Studies oncologie

Studies oncologie

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University Clinical Research Center Antwerp (UNICCRA)

De research unit is een onderdeel van de oncologische afdeling binnen het UZA. Het doel van de research unit is nieuwe, betere en steeds meer doeltreffendere behandelingen vinden om kankerpatiënten te behandelen. Klinische studies zijn hiervoor de beste methode. Tijdens deze klinische studies kunnen onze onderzoekers bepalen welke behandelingen veiliger, effectiever en beter zijn dan huidige behandelingen. De research unit bestaat uit artsen, studie coördinatoren, logistieke medewerkers, studie verpleegkundigen, pathologen en administratieve medewerkers. 

Hoe kan ik de research unit bereiken?

Heb je vragen over de studies binnen de research unit? Neem gerust contact met ons op via 03 821 55 80, 03 821 53 07 of via research [dot] oncologie [at] uza [dot] be

Studies fase 1/basket oncologie 

Title Tumortype  Line of therapy Study information Status Register 

KISIMA-01: Phase Ib Study to evaluate the safety, tolerability and anti-tumor activity of ATP128, with or without BI 754091 in patients with stage IV CRC


  • Cohort 2: MSS or MSI
  • Cohort 3 and 4: MSS or MMR proficient
  • Cohort 2c: 2L, ongoing PR or SD after completion of 1st line SOC therapy (min. 6 months)
  • Cohort 2b and 4b: prior neoadjuvant SOC, no PD on prior neoadjuvant SOC, m+ limited to liver, eligible for en block surgery with curative intent
  • Cohort 3 and 4a: 2L, PR or SD after completion of 1st line SOC systemic therapy (min. 4 months) 
  • 1 liver lesion amenable to repeated biopsy
  • ATP128, VSV-GP128: chimeric recombinant protein vaccine
  • BI754091: anti-PD1
  • Cohort 2a, 2b, 2c: ATP128 + BI 754091 
  • Cohort 3, 4: ATP128 + VSV-GP128 + BI 754091


MCLA-145-CL01: A Phase 1, Open-label, Dose-escalation study of MCLA-145 in participants with advanced or metastatic malignancies 

  • Preferred: NSCLC, melanoma, H&N, urothelial cancer or MSI-H/dMMR tumors with PD-L1 >1%, that already received previous anti-PD-L1
  • MM approval: solid tumors with PD-L1 >1%
  • Dual CD137 + Anti-PD-L1 antibody 
  • Prior anti-PD-1 is allowed (max 1 line)
  • Mandatory pre- and on-treatment biopsy
  • Specific inclusion criteria for TNBC, melanoma, HNSCC and urothelial carcinoma


eNRGy: Full molecular testing by RNA/DNA next generation sequencing to detect RNA/DNA alterations (including NRG1 fusions) 

  • Adenocarcinoma of the pancreas (≤ 60 years old at the time of diagnosis)
  • Sponsor: Merus 
  • Whole genome sequencing of RNA/DNA (200 genes) 
  • Locally advanced/metastatic
  • Has been or is currently being treated with SOC
  • No known mutations: ALK, BRAF, EGFR, KRAS, MET, NRAS, RET, ROS1 and absence of known mutations on actionable genes 
  • PS 0-2
  • In case of NRG1 fusion, possibility to enter Early Access Program examining the safety and efficacy of Zenocutuzumab (

MATTERS: A mono-centric, first in-human (FIH), safety and preliminary efficacy study of (neo)adjuvant, model-based, whole-body hyperthermia (WBHT) treatment in advanced solid cancer patients or stage IV (TxNxM1) metastatic pancreatic adenocarcinoma patients

Solid - stage IV  All
  • Cohort A1: Three patients with advanced solid cancer will be subjected to repetitive hyperthermia starting with 2 hours (day 1), 4 hours (day 8) and 6 hours (day 15)
  • Cohort A2: The highest whole-body hyperthermia duration with acceptable side effects from cohort A1 will be applied to three additional patients with advanced solid cancer, once a week and for 15 days in total
  • Cohort B1: Three pancreatic cancer patients will be subjected to repetitive hyperthermia starting with 2 hours (day 1), 4 hours (day 8) and 6 hours (day 15) using the device and in combination with the standard of care chemotherapy (FOLFIRINOX, FOLFOX, gemcitabine/nab-paclitaxel or gemcitabine alone).
  • Cohort B2: The highest whole-body hyperthermia duration with acceptable side effects from cohort B1 will be applied in combination with chemotherapy (FOLFIRINOX, FOLFOX, gemcitabine/nabpaclitaxel or gemcitabine alone) to three additional pancreatic cancer patients, once a week and for 15 days in total
Open NCT04467593

INCB99280-112: A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Select Advanced Solid Tumors

  • MSI-high or MMR-deficient tumors (all types except brain)
  • TMB >10
  • Cutaneaous squamous cell carcinoma
  • HCC
  • DL-1 positive esophageal squamous cell carcinoma
  • Merkel cell carcinoma
  • SCLC
  • PDL-1 positive mesothelioma
  • Any PDL-1 amplified tumor (9p24.1)
  • Urothelial carcinoma with CPS >= 10%
  • Nasopharyngeal carcinoma
  • Cyclin-dependent kinase 12 mutated tumors (loss of function, not amplification)
  • Basal cell carcinoma (unresectable or metastatic)
  • RCC with sarcomatoid features
  • Clear cell ovarian or endometrial carcinoma
  • DNA polymerase epsilon mutated tumors (P286R and V411L)
  • Other tumor types with approval of Medical Monitor
  • Progressed after SOC or intolerant/ineligible for SOC
  • No limit to number of prior treatment regimens, but maximum 1 line of immune therapy
  • Prior anti-PD-L1 is exclusion
  • Oral anti-PD-L1
  • Mandatory screening + on treatment biopsy
Slots NCT04242199

EZH-1201: A Phase I, Open-label Multi-dose Pharmacokinetic and Safety Study of Oral Tazemetostat in Subjects with Moderate and Severe Hepatic Impairment with Advanced Malignancies.

All tumortypes with:

  • Moderate hepatic impairment -> slots
  • Severe hepatic impairment -> slots 
Prior SOC 
  • Moderate hepatic impairment: bilirubin from 1.5 to 3 x ULN
  • Severe hepatic impairment: bilirubin >= 3 x ULN
  • Oral tazemetostat
  • Intensive PK sampling


ARRAY 818-103: An Open-label Phase 1 Study to Evaluate Drug-Drug Interactions of Agents Co-Administered With Encorafenib and Binimetinib in Patients With BRAF V600-mutant Unresectable or Metastatic Melanoma or Other Advanced Solid Tumors

BRAF V600E/V600K mutated solid tumors

  • Progressed after SOC or intolerant/ineligible for SOC
  • No limit to number of prior treatment regimens
  • Prior BRAF/MEK inhibitor is permitted, except as last line
  • Arm 1: CYP probe cocktail (oral) + encorafenib and binimetinib
  • After drug-drug interaction period (first 28 days), patient proceeds with encorafenib and binimetinib
On Hold


TRIDENT-1: A Phase 1/2, Open-Label Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

  • Solid tumors with NTRK rearrangements
  • Solid: maximum 2 prior TKI’s, no limit on prior lines of chemotherapy/immune therapy
  • Oral repotrectinib = novel TKI
  • Different cohorts according to prior TKI and chemo/immune therapy


JZLA/EMBER: A Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With ER+ Locally Advanced or Metastatic Breast Cancer and Other Select Non-Breast Cancers

  • Part C: ER+/HER2+ mBC
  • Part D: ER+ endometroid endometrial cancer
  • Part C: min. 2 prior HER2 directed regimens for advanced disease, prior trastuzumab & pertuzumab & TDM-1, no prior CDK4/6i, no prior fulvestrant
  • Part D: progression on platinum-based SOC, no prior AI, no prior fulvestrant
  • LY3484356 (oral) monotherapy or in combination with other drugs
  • Part C: LY3484356 + trastuzumab +/- abemaciclib
  • Part D: LY3484356 +/- abemaciclib


TAPISTRY/BO41932: Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study

  • Cohort A: solid tumors with ROS1 fusion, except NSCLC
  • Cohort B: solid tumors with NTRK1/2/3 fusion
  • Cohort C: solid tumors with ALK fusion, except NSCLC
  • Cohort D: solid tumors with TMB >= 16 --> Hold
  • Cohort E: solid tumors with AKT1/2/3 point mutation --> Closed
  • Cohort F: solid tumors with HER2 point mutation, except primary CNS (Hold)
  • Cohort H: solid tumors with >= 2 PIK3CA point mutations
  • Cohort I: solid tumors with class II BRAF mutations/fusions
  • Cohort J: solid tumors with class III BRAF mutations
  • Cohort K: solid tumors with RET fusion, except NSCLC
  • Cohort A: prior SOC/none available, prior ROS1 inhibitor is exclusion
  • Cohort B: prior SOC/none available, prior NTRK inhibitor is exclusion
  • Cohort C: prior SOC/none available, prior ALK inhibitor is exclusion
  • Cohort D: prior SOC/none available, prior CF137 agonist or checkpoint inhibitor are exclusions --> Hold
  • Cohort E: prior SOC/none available, prior AKT inhibitor is exclusion --> Closed
  • Cohort F: prior SOC/none available, prior doxorubicin > 500mg/m2 and prior trastuzumab emtansine are exclusions --> Hold
  • Cohort H: prior SOC/none available, prior PIK3 inhibitor is exclusion
  • Cohort I: prior SOC/none available
  • Cohort J: prior SOC/none available
  • Cohort K: prior SOC/none available, prior RET inhibitor is exclusion
  • Cohort A: entrectinib oral
  • Cohort B: entrectinib oral
  • Cohort C: alectinib oral
  • Cohort D: atzeolizumab IV --> Hold
  • Cohort E: ipatasertib oral, specific mutations --> Closed
  • Cohort F: kadcyla IV, specific, specific mutations --> Hold
  • Cohort H: inavolisib oral, specific mutations
  • Cohort I: Belvarafenib oral, specific mutations --> Hold
  • Cohort J: Belvarafenib oral, specific mutations --> Hold
  • Cohort K: Pralsetinib oral


BI1472-0001: A Study to Test Different Doses of BI 1823911 Alone and Combined With Other Medicines in People With Different Types of Advanced Cancer With KRAS Mutation

  • All solid tumors with KRAS G12C mutation
  • Prior SOC or no SOC available
  • Prior RAS, MAPK or SOS1 targeted therapy is not allowed
  • Oral study medication
  • Intensive PK sampling with overnight hospital stays


MCLA-129: Phase 1/2 dose escalation and expansion study evaluating MCLA-129, a human anti-EGFR and anti-c-MET bispecific antibody, in patients with advanced NSCLC and other solid tumors

  • Cohort B: NSCLC cMet exon 14 skipping mutation
  • Cohort C: HNSCC eligible regardless of mutation, the following tumor types with EGFR or cMet mutation (only with medical monitor approval!): GC, GEJ, pancreas, ESCC, GBM and PRCC, NSCLC with rare EGFR mutation
  • Cohort D: NSCLC 1L harboring EGFR sensitizing mutations (i.e. Del19, L858R)
  • Cohort E: NSCLC >=2L osimertinib resistant + chemo naive 
  • Cohort B: ≥ 2L, capmatinib and tepotinib resistant 
  • Cohort C: prior SOC or intolerance
  • Cohort D: 1L
  • Cohort E: >=2L
  • MCLA-129 IV Q2W: biospecific monovalent EGFR x cMET antibody
  • Mandatory on-treatment biopsy
  • Intensive PK sampling with overnight hospital stay
  • Cohort B, C: MCLA-129 monotherapy
  • Cohort D, E: MCLA-129 + osimertinib


OPTIMIZE-1: A phase 1b/2 study assessing the safety and efficacy of mitazalimab in combination with chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma

  • Pancreatic ductal adenocarcinoma
1st line (previously untreated)
  • Mitazalimab (CD40 agonist) IV Q2W + mFOLFIRINOX Q2W
  • Mandatory pre- and on- study biopsies


GO42144: A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

KRAS G12C mutated
  • CRC
  • All other 
Prior SOC or intolerance
  • Oral study medication
  • Intensive PK sampling 


BALLETT: A study to examine the clinical value of comprehensive genomic profiling performed by Belgian NGS laboratories: a Belgian Precision study of the BSMO in collaboration with the Cancer Centre

All solid tumors All (early lines are preferred)
  • Sponsor: BSMO
  • Patients with advanced/metastatic solid tumors that are candidates for systemic therapy
  • Life expectancy < 12 weeks
  • ECOG ≤ 2
  • Tumor tissue < 2 years old
  • Patients should also enter the Precision-1 trial (Health Data database - Sciensano)
  • National ‘Molecular Tumor Board’ provides therapy recommendation based on CGP results


SGNTUC-019: Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations

  • Her2 overexpression/amplification: cervical, uterine and urothelial cancer
  • Specific Her2 mutation: breast cancer
  • At least 1 prior SOC
  • For HR+ Her2-mutated breast: prior CDK4/6 inhibitor in metastatic setting 
  • Tucatinib PO BID + Trastuzumab IV Q3W
  • Fulvestrant addition for HR+ Her2 mutated breastcarcinoma


INCB 99318-122: A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Select Advanced Solid Tumors

  • MSI-high or MMR-deficient tumors (all types except brain)
  • TMB >10
  • Cutaneaous squamous cell carcinoma
  • HCC
  • PDL-1 positive esophageal squamous cell carcinoma
  • Merkel cell carcinoma
  • SCLC
  • PDL-1 positive mesothelioma
  • Any PDL-1 amplified tumor (9p24.1)
  • Nasopharyngeal carcinoma
  • Cyclin-dependent kinase 12 mutated tumors (loss of function, not amplification)
  • Basal cell carcinoma (unresectable or metastatic)
  • RCC with sarcomatoid features
  • Clear cell ovarian or endometrial carcinoma
  • DNA polymerase epsilon mutated tumors (P286R and V411L)
  • Other tumor types with approval of Medical Monitor
  • Progressed after SOC or intolerant/ineligible for SOC
  • No limit to number of prior treatment regimens, but maximum 1 line of immune therapy
  • Prior anti-PD-L1 is exclusion
  • Oral anti-PD-L1
  • Mandatory screening + on treatment biopsy


BT5528-100: A Phase I/II study of BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression

  • Urothelial cancer
  • Ovarian cancer
  • H&N
  • TNBC
  • Gastric/upper GI
  • Prior SOC 
  • No limit to number of prior treatment regimens
  • No prescreening anymore for EphA2 expression
  • BT5528 IV QW or Q2W
  • Intensive PK sampling during first cycle


20210102 (AMG552): A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Bemarituzumab Monotherapy and Combination with Docetaxel in Subjects with Squamous-Cell Non-Small-Cell Lung Cancer (FORTITUDE-201)

  • Squamous cell lung carcinoma
  • Centrally confirmed FGFR2b overexpression
  • Part 1 and 2: at least 1 prior regimen
  • Part 3: at least 2 prior regimens
  • Part 4: no prior therapy in metastatic setting
  • Prior treatment must include platinum chemotherapy and checkpoint inhibition, and targeted therapy (if applicable)
  • Prescreening for FGFR2b overexpression determination
  • Part I and 2: bemarituzumab IV Q3W + docetaxel IV Q3W
  • Part 3: bemarituzumab IV monotherapy Q2W
  • Part 4: bemarituzumab IV Q3W + pembro IV Q3W + (nab)-paclitaxel/carboplatin IV Q3W
Slots  NCT05267470

AMG 20190135: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation

  • Subprotocol F, all cohorts: NSCLC
  • Subprotocol H: 
    • Cohort C: NSCLC
    • Cohort D, F, G: CRC
  • Subprotocol F: 
    • Cohort B: prior platinum and/or anti-PD(L)-1 and targeted therapy (if applicable)
    • Cohort A1: 1st line (no prior platinum, no prior anti-PD(L)-1)
    • Cohort A2: prior anti-PD(L)-1 mono or prior platinum-based combination
  • Subprotocol H: 
    • Cohort B: at least 1 prior KRAS G12c inhibitor for which progression, at least 1 prior treatment line
    • Cohort C: at least 1 prior SOC, no prior KRAS G12C inhibitor
    • Cohort D: 1 prior SOC in metastatic setting, no prior KRAS G12C inhibitor
    • Cohort F: 1st line (no prior SOC in metastatic setting), no prior KRAS G12C inhibitor
    • Cohort G: at least 1 prior SOC, no prior KRAS G12C inhibitor
  • Subprotocol F:
    • Cohort B: sotorasib + doxetaxel
    • Cohort A1 and A2: sotorasib + carboplatinum + pemetrexed
  • Subprotocol H:
    • Cohort B, C, D: sotorasib + panitumumab
    • Cohort F, G: sotorasib + panitumumab + FOLFIRI
  • Mandatory screening and on-treatment biopsy 
Slots NCT04185883

CL1-95012-001: A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors

Solid tumors
  • Prior SOC, no restriction on number
  • Prior anti-PD(L)-1 is allowed
  • PRS-344/S095012 IV Q2W
  • Intensive PK sampling during cycle 1 and 2
Slots NCT05159388

20210023 (AMG193): AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors (MTAP) 

  • Solid tumors
  • MTAP-null and/or CDKN2A-null, or lost MTAP expression (local testing)
  • Prior SOC or ineligible
  • AMG193 oral
Slots NCT03564340

XL092-001: A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects with Inoperable Locally Advanced or Metastatic Soli

  • Cohort A (ccRcc)
  • Cohort B (nccRCC)
  • Cohort E (nccRCC)
  • Cohort F (HR+BC)
  • Cohort G (mCRPC)
  • Cohort H (CRC): KRAS/NRAS wild type
  • Cohort A, B, E, F: 1-3 prior lines
  • Cohort G: 1-4 prior lines
  • Cohort H: prior SOC 
  • XL092: a small molecule inhibitor of RTKs, primarily targeting MET and VEGFR2 
  • Cohort A, B: XL092 
  • Cohort E, F, G: XL092 + atezolizumab 
Slots NCT03845166

20210104 (AMG 552): A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors with FGFR2b Overexpression (FORTITUDE-301) 

  • Head and Neck Squamous Cell
  • Squamous esophageal
  • Triple-negative breast
  • Pancreatic ductal adenocarcinoma
  • Intrahepatic cholangiocarcinoma
  • Colorectal 
  • Platinum-resistant Ovarian epithelial
  • Endometrial
  • Cervical
  • Other FGFR2b+ solid tumors, except for primary CNS tumors, squamous NSCLC, gastric and GEJ adenocarcinoma 
  • TNBC, CRC: at least 2 lines
  • All other tumor types: at least 1 line
  • Bemarituzumab (AMG 552): a monoclonal antibody against FGFR2b, IV Q2W
  • Pre-screening for central IHC FGFR2b overexpression (tissue <10y)
Slots NCT05325866

WP43295: A phase 1a/b open-label study to evaluate safety, pharmacokinetics, and preliminary clinical activity of RO7276389 alone and in combination with cobimetinib in participants with BRAF-V600 mutation-positive advanced solid tumor or BRAF-V600 mutation-positive melanoma with central nervous system metastases

  • Part 1: Metastatic or locally advanced solid tumors with BRAF-V600 mutation
  • Part 2: Cutaneous melanoma with asymptomatic brain metastases 
Prior SOC
  • RO7276389: a potent RAF inhibitor targeting mutant BRAF V600E/K protein
  • Part 1a, part 2 cohorts 1 & 2: monotherapy RO7276389
  • Part 1b, part 2 cohorts 3 & 4: combination RO7276389 with cobimetinib
Slots ISRCTN13713551

61186372GIC2002 (ORIGAMI-1): A Phase 1b/2, Open-Label Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants with Advanced or Metastatic Colorectal Cancer

  • Cohort A: left sided, no prior anti-EGFR therapy
  • Cohort B: left sided, with prior EGFR-therapy
  • Cohort C: right sided
  • Cohort D: left or right sided, no prior oxaliplatin or anti-EGFR therapy
  • Cohort E: left or right sided, no prior irinotecan or anti-EGFR therapy
  • Cohort A, B, C: 3-4 L
  • Cohort D, E: 2L
  • Amivantamab: an antibody directed against EGF and MET receptors
  • Cohort A, B, C: amivantamab monotherapy
  • Cohort D: amivantamab + mFOLFOX6
  • Cohort E: amivantamab + FOLFIRI
Slots NCT05379595

TES16382: Open-label study evaluating the effect of tusamitamab ravtansine on the QTc interval in participants with metastatic solid tumors

  • CRC 
  • Non-squamous NSCLC
  • GC/GEJ
Prior SOC or intolerant
  • Pre-screening for CEACAM5 expression, required for NSCLC and GC/GEJ
  • No pre-screening required for CRC 
  • Tusamitamab ravtansine (90 min IV, Q2W)
Slots NCT05429762

20200469: A Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects with Extensive Stage Small Cell Lung Cancer

  • SCLC
  • Part 1, 2, 3: AMG757 (tarlatamab) + carboplatin/etoposide + atezolizumab
  • Part 5: AMG757 (tarlatamab) + atezolizumab 
Slots NCT05361395

MK6482-016: An Open-label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Multiple Solid Tumors

  • Cohort A: HCC
  • Cohort B: CRC
  • Cohort C: pancreas
  • Cohort D: biliary tract
  • Cohort E: endometrium
  • Cohort F, G: ESCC
  • Cohort A: 1L
  • Cohort B: 3L
  • Cohort C: 2L
  • Cohort D: 2L
  • Cohort E: 1L, non-MSI-H
  • Cohort F: 2L, IO naïve
  • Cohort G: 2L, IO refractory
  • Pembrolizumab Q6W + lenvatinib + belzutifan
  • Belzutifan: inhibitor of HIF-2α
  • Lenvatinib: inhibitor of VEGFR1-3
Slots NCT04976634

KBA1412-101: A Phase I, first-in-human, multicenter, open-label, dose escalation followed by an expansion phase clinical study of KBA1412 given as monotherapy or in combination with pembrolizumab in adults with advanced solid malignant tumors 

  • Part A: all solid tumors
  • Part B, C: melanoma, ovarian cancer, gastric cancer, CRC
  • Part A: All
  • Part B, C: Prior PD(-L)1 therapy, if this is SOC
  • Part A, B: KBA1412 monotherapy
  • Part C: KBA1412 + pembrolizumab
  • KBA1412 = anti-CD9 human monoclonal antibody, IV
Slots NCT05501821

DAY101-102: A Phase 1b/2, Open Label Study of DAY101 Monotherapy or Combination with Other Therapies for Patients with Recurrent, Progressive, or Refractory Solid Tumors Harboring MAPK Pathway Aberrations

All solid tumors with:
  • BRAF fusion with intact kinase domain except SEPT3-BRAF
  • CRAF/RAF1 fusion
  • CRAF/RAF1 amplification
Prior SOC or intolerant
  • DAY101 monotherapy
  • DAY101: oral type II pan-RAF kinase inhibitor
  • Archival tissue <1y old
Slots NCT04985604

DO2.22.01: A Phase 1 Study to Determine the Safety, and Pharmacokinetics of the Selective MET kinase Inhibitor, DO-2 in Patients With Advanced or Refractory Solid Tumours

All solid tumors with:
  • MET activating mutation
  • MET amplification >10 GCN
  • Hereditary renal papillary cancer
  • Treatment naive with no current options
  • Prior SOC (prior MET inhibitor without PD is allowed)
  • Intolerance
  • DO-2: Oral MET kinase inhibitor

INCA0186-101: A Phase 1, Open-Label, Multicenter Study of INCA00186 as Monotherapy or in Combination With Immunotherapy in Participants With Advanced Solid Tumors

  • CRC
  • Gastric/GEJ cancer
  • HCC
  • PDAC
  • SCAC (SCC of anal canal)
Prior SOC
  • Cohort A: INCA00186 monotherapy
  • Cohort C: INCA00186 + INCB105385 + Retifanlimab 
  • INCA00186: mAb that binds CD73, IV Q2W
  • INCB105385: oral antagonist of A2A and A2B receptors, QD
  • Retifanlimab: anti-PD-1, IV Q4W
  • Mandatory pre-screening biopsy for presence of CD8+ T cells (if negative, patient can participate to backfill cohort)
Slots NCT04989387

1403-0011 (Brightline-2): A Phase IIa/IIb, open-label, single-arm, multi-centre trial of BI 907828 for treatment of patients with locally advanced/metastatic, MDM2 amplified, TP53 wild-type biliary tract adenocarcinoma, pancreatic ductal adenocarcinoma, or other selected solid tumours

MDM2 amplified, TP53 wild-type solid tumours:
  • Cohort 1: biliary tract adenocarcinoma
  • Cohort 2: pancreatic ductal adenocarcinoma
  • BI 907828 monotherapy
  • BI 907828: oral MDM2-p53 antagonist, Q3W, 45 mg 
  • MDM2 amplification and TP53 wild type on local testing
Open NCT05512377

1412-0003: A phase Ia/Ib, open label, multicentre, dose escalation study of BI 905711 in combination with chemotherapy followed by expansion cohorts in patients with advanced gastrointestinal cancers

  • Cohort 1: CRC
  • Cohort 2: PDAC (CDH17 positive pancreatic adenocarcinoma) 
  • Cohort 1 (CRC): Folfiri + bevacizumab +- BI 905711 (randomisatie 2:1)
  • Cohort 2 (PDAC): BI 905711 + Folfiri (of liposomal irinotecan + 5FU/leucovorin)
  • BI 905711: Bispecific antibody targeting TRAILR2 and CDH17
  • Fresh biopsy or archival tissue <6m old
On hold


Studies borstkanker 

Title Tumortype Line of therapy Study information Status Register
The AURORA PROGRAM: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer All 1-2L
  • Molecular study, no study treatment
  • Blood samples every 6 months and at progression
  • Biopsy after first or second progression and prior to next line of therapy
Hold NCT02102165
SERENA-4: A Randomised, Double-Blind, Phase III Study of AZD9833 (an Oral SERD) plus Palbociclib vs Anastrozole plus Palbociclib for the Treatment of Patients with ER-Positive, HER2-Negative Advanced Breast Cancer  who Have Not Received Any Systemic Treatment for Advanced Disease HER2-/ER+ 1L
  • AZD9833/Placebo + Placebo/Anastrazole + Palbociclib
  • De novo m+ allowed --> on HOLD
  • If adj. ET treatment: min 24 months AI or Tamoxifen
  • If adj. AI +/- CDK4/6 inhibitor: PD after min. 12 months completion of adj. therapy
WO41554/INAVO120: Phase III, double-blind, placebo-controlled study evaluating the efficacy and safety of GDC-0077/Placebo plus Palbociclib and Fulvestrant in patients with PIK3CA-mutant, Hormone Receptor-Positive, Her2-Negative locally advanced or metastatic breast cancer. HER2-/HR+ 1L
  • PIK3CA mutant
  • PD on or within 12 months of completing adjuvant treatment
  • Measurable disease per RECIST 1.1
  • GDC-0077/Placebo + Fulvestrant + Palbociclib
Open NCT04191499
DESTINY-Breast09: Phase III, Trastuzumab Deruxtecan (T-DXd) with or without Pertuzumab vs Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast cancer. HER2+ 1L
  • HER2+ must be centrally confirmed
  • No prior therapy in m+ setting
  • 3 study arms (1:1:1)
    • ARM 1: T-DXd + Pertuzumab
    • ARM 2: T-DXd + Placebo
    • ARM 3 : Taxane (paclitaxel QW or docetaxel Q3W) + Trastuzumab + Pertuzumab
Open NCT04784715
DESTINY-Breast08: Phase Ib of Trastuzumab Deruxtecan (T-DXd) in combination with other Anti-Cancer Agents in patients with Metastatic HER2-low Breast Cancer. TNBC

Module 1: 0-2L --> on Hold

Module 2: 1L

Module 3: 0-2L

  • Participation in Part 2 TNBC modules:
  • Module 1: T-DXd + capecitabine
  • Module 2: T-DXd + durvalumab + paclitaxel
  • Module 3: T-DXd + capivasertib
Closed NCT04556773

DESTINY-05: A phase 3, multicenter, randomized, open-label, active-controlled study of trastuzumab deruxtecan (T-DXd) vs T-DM1 in subjects with high-risk HER2-positive primary breast cancer who have residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy.

HER2+ Adjuvant
  • HER2+ centrally confirmed prior to randomization.
  • Operable at presentation: cT1-3,N0-1,M0, with axillary node positive disease (ypN1-3) following neoadjuvant therapy.
  • Inoperable at presentation: cT4,N0-3,M0 or T1-3,N2-3,M0. 
  • At least 6 cycles of neoadjuvant chemotherapy (min 16 weeks in total), including min. 9 weeks of trastuzumab + min. 9 weeks of taxane based chemotherapy.
  • No prior treatment with T-DXd, T-DM1 or other anti-HER2 antibody-drug conjugate.
Open  NCT04622319

lidERA: a phase III, randomized, open-label, multicenter study evaluating the efficacy and safety of adjuvant giredestrant compared with physician's choice of adjuvant endocrine monotherapy in patients with estrogen receptor positive, her2-negative early breast cancer

ER+/HER2- Adjuvant
  • Medium and high risk stage I-III 
  • Arm A: giredestrant QD
  • Arm B: ET per SOC 
Open NCT04961996

AL-2001 (Allarity): Phase II, open label, single arm study to investigate anti-tumor effect of ixabepilone in patients with locally recurrent or metastatic breast cancer (mBC)

TNBC and HER2-/HR+ 4L
  • Ixabepilone
  • DRP score centrally confirmed.
  • Patient must have received a taxane and an anthracycline, unless not indicated
  • Number of ET does not matter
Open  NCT04796324

Studies gynaecologische oncologie 

Title Tumortype Line of therapy Study information Status Register

R4018-ONC-1721: Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer 

Ovarian carcinoma of epithelial origin
  • At least 1 prior platinum line for which progression
  • REGN4018 IV QW as monotherapy OR REGN4018 IV QW + cemiplimab IV Q3W
  • Mandatory screening biopsy
  • Very intensive study with mandatory hospitalization after the first 3-6 REGN4018 administrations (depending on cohort)
  • Very intensive PK sampling
Slots NCT03564340

FLORA-5: Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery

  • Ovarian: stage III or IV
  • BRCA1/2 negative
  • New diagnosis
  • After (interval) debulking surgery (with R0 or R1 resection)
  • Oregovomab = anti-CA-125 antibody
  • Primary debulking: 6 cycles of carbo/paclitaxel + 4 administrations of oregovomab/placebo IV
  • Interval debulking: 3 additional cycles of carbo/paclitaxel + 4 administrations of oregovomab/placebo IV
Open  NCT04498117

Studies digestieve oncologie 

Title  Tumortype Line of therapy Study information Status Register
 ASPIRIN: A Randomised, double–blind, placebo-controlled Trial of Aspirin to prevent Recurrence   Colon Cancer  Adjuvant
  • Aspirin versus placebo
  • Ro resection
  • >45year
  • stage II-III
 Open   NCT03464305

A Study of Atezolizumab With or Without Tiragolumab in Participants With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy 


 Unresectable locally advanced esophageal squamous cell carcinoma   1
  • Arm A: Tiragolumab + atezolizumab
  • Arm B: Tiragolumab + placebo 
  • Arm C: placebo + placebo 
  • Randomized (1:1:1), double-blind, phase III study 
  • Stage II-IVA esophageal squamous cell (8th edition) 
  • Received at least 2 cycles platinum-based chemo and radiation consistent with definitive treatment without evidence of disease progression 
  • Randomization must occur with 1-63 days after last dose definitive concurrent chemo radiotherapy  
 Open  NCT04543617

Neoadjuvant Regorafenib in Combination With Nivolumab and Short-course Radiotherapy in Intermediate-risk, Stage II-III Rectal Cancer 


Rectal cancer Neo-adjuvant
  • Regorafenib + nivolumab + short-course radiotherapy
  • Intermediate-risk stage II-III 


A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer



Advanced gastric or gastroesophageal junction 2L-3L
  • phase 2: ALX 148 + Trastuzumab + Ramicirumab+ Paclitaxel vs Trastuzumab  +Ramicirumab + Paclitaxel 
  • phase 3:  ALX 148 + Trastuzumab + Ramicirumab+ Paclitaxel vs Ramicirumab + Paclitaxel
  • HER2 positive tumor
  • Progression on or after prior HER2 directed agent + 5FU or platinum containing regimen


Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression 

AMGEN 20210096 FORTITUDE-101

Advanced gastric or gastroesophageal junction  1L
  • Bemarituzumab versus placebo +chemotherapy  (folfox 6)
  • FGRF2b central testing by IHC
  • HER2 positive tumor is exclusion if known


Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen 



Advanced gastric or gastroesophageal junction 2L
  • Trastuzumab Deruxtecan versus Ramicirumab+Paclitaxel
  • Centrally confirmed HER2- positive tumor (IHC3+ or IHC 2+)
  • Progression on or after first line Trastuzumab-containing regimen


A Trial to Assess Efficacy and Safety of Octreotide (CAM2029) Subcutaneous Depot in Patients With GEP-NET 


  • CAM2029 versus octreotide LAR or lanreotide ATG
  • Well-differentiated NET of GEP
  • Progression during treatment (including SSAs)


Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation 



Advanced colorectal cancer  2L
  • MRTX 849 + cetuximab versus chemotherapy
  • KRAS G12C mutation
  • Disease progression on 1st line


Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer

AMGEN 20210098 - FORTITUDE-102

Unresectable (locally advanced or metastatic) gastric of GEJ adenocarcinoma 1st line 
  • Bemarituzumab + mFOLOFOX6 + Nivolumab Versus Placebo + mFOLFOX6 + Nivolumab
  • No prior treatment for metastatic or unresectable disease except for a maximum of 1 dose of mFOLFOX6 with or without nivolumab. 
  • FGFR2b overexpression positive as determined by centrally performed immunohistochemistry (IHC) testing
  • Prior treatment with (FGF—FGFR pathway is exclusion


FOLICOLOR Trial: Following therapy response through Liquid Biopsy in metastatic colorectal cancer patients

(unresectable) Metastatic colorectal Cancer 1L
(2-3L if recurrence)
  • Randomized trial: Therapy response CT-scan VS. Liquid Biopsy
  • Starting FOLFOX/FOLFIRI + Panitumumab
  • No history of anti- EGFR
  • RAS/BRAF (V600E) WT
  • ECOG 0-2
  • > 18 years


A non-comparative randomized phase 2 study, evaluating the efficacy of 5-FU + Naliri and 5-FU + Nalirinox for metastatic pandreatic ductal adenocarcinoma

Metastatic PDAC 2L
  • Randomized trial 1:1: 
  • Arm A (standard of care arm): nal-IRI + 5-FU/LV (NALIRI)
  • Arm B (experimental arm): nal-IRI + 5-FU/LV + OxaliplatinECOG 0-2
  • Progression After 1L gemcitabine mono OR gemcitabine/abraxane
Open  NCT05472259


Collection of Liquid Biopsies in Pancancer patients

Colon adenomCa, Rectum adenoCa, Pancreas adenoCa, Hepatocellulair Ca, slokdarm plaveivelcelCa 1L
  • Liquid Biopsy collection new diagnoses 
  • No NET-tumours

Studies hoofd- en halsoncologie

Title Tumortype Line of therapy Study information Status Register
UPSTREAM: A pilot study of personalized biomarker-based treatment strategy or immunotherapy in patients with recurrent/metastatic squamous cell carcinoma of the head and neck


  • oral cavity 
  • oropharynx
  • hypopharynx
  • larynx 
>1L, platinum failed 
  • Fresh tumor core biospy, centrally assessed
  • Cohort I2: Pretreated with prior PD(L)1 --> Closed
  • Cohort I3: Last treatment line was PD(L)1
  • Cohort B1: p16 negative and EGFR amplification/mutation or PTEN high or HER2 amplification/mutation --> closed
  • Cohort B2: p16 negative and cetuximab naïve
  • Cohort B3: p16 negative and CCND1 amplification
  • Cohort B4: p16 negative and ‘platinum-sensitive’
  • Cohort B5: p16 positive oropharyngeal cancer --> closed
  • Cohort I2: monalizumab + durvalumab vs. physician's choice
  • Cohort I3: INCAGN01876
  • Cohort B1 + B2: afatinib vs. physician's choice
  • Cohort B3: palbociclib vs. physician's choice
  • Cohort B4 + B5: Niraparib
Open  NCT03088059

JZJB/LIBRETTO-531: A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing Selpercatinib to Cabozantinib or Vandetanib in Patients with Progressive, Advanced, Kinase Inhibitor Naïve, RET-Mutant Medullary Thyroid Cancer 


  • Crossover possible
  • Patients from 12 yo
On hold NCT04211337 

TACTI-003 (Two ACTive Immunotherapeutics): A multicenter, open label, randomized, Phase II trial to investigate a soluble LAG-3 fusion protein, eftilagimod alpha (efti; IMP321) in combination with pembrolizumab (PD-1 antagonist) for first line treatment of subjects with unresectable recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC) 

Recurrent or metastatic squamous cell carcinoma of the H&N 

  • CPS >= 1 : Efti + pembrolizumab vs pembrolizumab mono
  • CPS < 1 : Efti + Pembrolizumab
  • Disease progression on 1st line
Open  NCT04811027

ProcemISA: A Phase II Study of cemiplimab, an anti-PD-1 monoclonal antibody, and ISA101b vaccine in patients with recurrent/metastatic HPV16- positive Oropharyngeal Cancer who have experienced disease progression with prior anti-PD-1 therapy

SCCHN Oropharynx HPV16+

  • Recurrent/ metastatic
  • Local HPV16 PCR or ISH
  • Must have previously received at minimum 600 mg pembrolizumab or 960 mg nivolumab for 1L or 2L
  • Last dose IO not more than 6 months prior to first dose in trial and should be last regimen
  • PD on or after IO
  • 4 x ISA101b vaccin + Cemiplimab q3w
Open NCT04398524

ELEVATE: A Phase 2 Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma


  • oropharynx
  • oral cavity
  • hypopharynx
  • larynx
1L / 2-3L
  • metastatic or unresectable, locally recurrent
  • Phase 2 cohort 1: 1L
    • arm A: magrolimab + pembrolizumab + platinum + 5-FU
    • arm B: pembrolizumab + platinum + 5-FU
  • Phase 2 cohort 3: 2-3L
    • magrolimab + docetaxel
Open NCT04854499

COLIPAN: collection of Liquid Biopsies in Pancancer patients

H&N plaveiselcelCa

  • Liquid Biopsy collection new diagnoses NO NET-tumours

Studies musculoskeletale oncologie (tumoren van de weke delen) 

Title Tumor Type Line of therapy Study information Status Register

Studies hersenkanker 

Title  Tumor Type Line of therapy Study information Status Register
ADDIT-GLIO: Adjuvant dendritic-cell immunotherapy plus temozolomide following surgery and chemoradiation in patients with newly diagnosed glioblastoma Glioblastoma Adjuvant
  • Estimated to start with chemoradiation ≥ 28 days and ≤ 49 days following surgical resection
  • No Prior radiation or chemotherapy
  • Total or subtotal resection
  • No corticosteroid treatment ≤ 1 week before
  • WT1 mRNA-loaded DC vaccination + CRT (temozolomide)
Open  NCT02649582

Studies urologische oncologie 

Title Tumor Type Line of therapy Study information Status Register
PEACE III: A Randomized phase III trial comparing enzalutamide vs. a combination of Ra223 and enzalutamide in asymptomatic or mildly symptomatic castration resistant prostate cancer patients metastatic to bone. Prostate cancer >= 1L
  • ≥ 2 bone metastases
  • Ongoing androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist or antagonist or bilateral orchiectomy
  • Prior docetaxel is permitted under the following conditions: started within 2 months of ADT initiation, given for a maximum of 6 cycles and progression after 6 months of the last dose of docetaxel.
  • ARM A: Enzalutamide
  • ARM B: Ra223 + Enzalutamide
open NCT02194842
KEYNOTE-676: A Phase 3, Randomized, Comparator-controlled Clinical Trials to study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Bacillus Calmette-Guerin (BCG) in Participants with High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) that is Persistent or Recurrent Following BCG Induction. Non-muscle invasive bladder carcinoma Persistent or recurrent following BCG induction
  • HR NMIBC: recurrent T1, high-grade Ta and/or CIS
  • Persistent: remains present within 3 months (-2 weeks) to 6 months (+4 weeks) after start of BCG induction (note: persistent T1 nog eligible)
  • Recurrent: reappearance of HR NMIBC after achieving a CR or tumor free state within 6 months after start of BCG induction. The recurrence must be within 24 months of last exposure to BCG (+56 days).
  • Prior cystoscopy/TURBT within 12 weeks prior to randomization.
  • For recurrent T1: restaging TURBT between 14-56 days prior to randomization.
 Open  NCT03711032
COLIPAN: collection of Liquid Biopsies in Pancancer patients Prostaat adenoCa 1L
  • Liquid Biopsy collection new diagnoses No NET-tumours 

Studies dermatologische oncologie (huidtumoren) 

Title  Tumor Type Line of therapy Study information Status Register
IFX-1-P2.8: Open label, multicenter Phase II study of the C5a-antibody IFX-1 alone or IFX-1 + pembrolizumab in patients with PD-1- or PD-L1-resistant/refractory locally advanced or metastatic cutaneous squamous cell carcinoma (cSCC) Cutaneous squamous cell carcinoma
  • Prior SOC
  • Anti-PD-(L)1 as last line for which progression within 12 weeks from last dose
  • randomization between IFX-1 monotherapy (IV) or IFX-1 with pembrolizumab
  • mandatory baseline biopsy 
Open  NCT04812535


De dienst thoraxoncologie is een onderdeel van het MOCA (Multidisciplinair Oncologisch Centrum Antwerpen) binnen het UZA. We behandelen patiënten met longkanker, longvlieskanker en thymustumoren. Naast standaard behandelingen bieden we ook behandelingen in studieverband aan. Het gaat hier om fase II en III klinische studies. Het doel van een klinische studie is om te onderzoeken of een nieuwe behandeling veiliger, effectiever en beter is dan huidige behandeling. Voor fase I klinische studies verwijzen we u naar de research unit.

Hoe kan ik de dienst thoraxoncologie bereiken? 

Heb je vragen over de studies binnen de dienst thoraxoncologie? Neem gerust contact met ons op via 03 821 31 07 of via thoraxoncologie [at] uza [dot] be.

Studies thoraxoncologie 

Title Tumor Type Line of therapy Study information Status Register
MARIPOSA-2: A Phase 3, Open-Label, Randomized Study of Amivantamab and Lazertinib in Combination with Platinum-Based Chemotherapy Compared with Platinum-Based Chemotherapy in Patients with EGFR-Mutated Locally Advanced or Metastatic NSCLC After Osimertinib Failure NSCLC 2L-3L
  • EGFR Exon 19del or Exon 21 L858R mutation
  • osimertinib as 1L (or second line after 1st/2nd gen EGFR TKI)
  • Randomization 2:2:1
  • Arm A: Lazertinib + Amivantamab + Pemetrexed + Carboplatin
  • Arm B: Pemetrexed + Carboplatin
  • Arm C: Amivantamab + Pemetrexed + Carboplatin
On hold NCT04988295 
AcceleRET: A Randomized, Open-Label, Phase 3 Study of Pralsetinib vs SOC for First Line Treatment of RET fusion-positive, Metastatic NSCLC  NSCLC stage III-IV 1L
  • Arm A: Pralsetinib PO

  • Arm B: Carboplatin or cisplatin/pemetrexed; Pembrolizumab/carboplatin or cisplatin/pemetrexed; Carboplatin or cisplatin/gemcitabine 

  • Tissue to be submitted (archived/fresh)

  • Crossover possible after central confirmed PD

Open NCT04222972
CARMEN-LC03: Randomized, Open Label Phase 3 study of SAR408701 versus Docetaxel in Previously Treated metastatic nonsquamous NSCLC patients with CEACAM5 positive tumors NSCLC >1L
  • CEACAM5 >=2+ in >=50% tumor cells (centrally assessed)
  • 1 prior platinum chemotherapy + 1 checkpoint inhibitor (+ targeted therapy if indicated)
  • No previous corneal disorder
  • Contact lenses are not permitted
Open NCT04154956
LUMINOSITY: Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ NSCLC


  • c-Met+ assessed by IHC (central)
  • prior chemotherapy (one line) AND prior immune checkpoint (N/A if mutant) AND prior TKI (sequential lines count as 1)
  • pre-screening can be done during prior line
  • Non-Sq EGFR WT c-MET high Stage 2
  • Non-Sq EGFR WT c-MET intermediate Stage 2
  • Non-Sq EGFR Mut c-MET high Stage 1 -> Closed 
  • Non-Sq EGFR Mut c-MET intermediate Stage 1 -> Closed
  • Squamous -> Closed


ALKALINE: Activity of Lorlatinib based on ALK resistance mutations on blood in ALK positive NSCLC patients previously treated with 2nd generation ALK inhibitor


  • stage IIIB - IV
  • ALK rearrangement, by FISH or IHC
  • treated with at least 1 2nd-generation ALK inhibitor
  • samples collected for cohort allocation during screening
  • prospective sub-study: 3-monthly LBx during the ongoing response to 2nd-generation ALK inhibitor


CARMEN-LC06: Open-label, Phase 2 study, evaluating the efficacy and safety of tusamitamab ravtansine in non-squamous NSCLC participants with negative or moderate CEACAM5 expression tumors and high circulating CEA


  • CEACAM5 IHC assessed through CARMEN-LC03 trial
  • Circulating CEA ≥100 ng/mL
  • Prior platinum chemotherapy + checkpoint inhibitor, but no more than 2 prior chemotherapies (+ targeted therapy if indicated)
  • no previous corneal disorder
  • contact lenses are not permitted


EVOKE-01: Open-Label, Global, Multicenter, Randomized, Phase 3 Study of Sacituzumab Govitecan Versus Docetaxel in Patients With Advanced or Metastatic NSCLC With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy


  • stage IV at time of enrollment
  • prior platinum + anti-PD-(L)1
  • Patients with EGFR, ALK, or any other known actionable genomic alternations must have also received treatment with at least 1 approved TKI 


DOLBY-LC01: Clinical verification study of epigenetic biomarker panels for the diagnosis of lung cancer (stage IV)

NSCLC and healty subjects

prior to 1L
  • Adeno and squamous
  • Healthy subjects:
    • never smoked or stopped >20y and no COPD
    • smoker >20 PY
  • Blood and urine collection
  • Tissue from patients only
  • Sample collection before start 1L
PACIFIC-8: A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre, International Study of Durvalumab plus Domvanalimab in Participants with Locally Advanced (Stage III), Unresectable NSCLC Whose Disease has not Progressed Following Definitive Platinum-based Concurrent Chemoradiation Therapy

NSCLC stage III, T1c-T3N0M0

1L maintenance
  • PD-L1 TC ≥ 1% assessed centrally during pre-screening while on cCRT
  • Must have not progressed following cCRT
  • Must have received at least 2 cycles of chemotherapy
  • Total dose of radiation of 60 Gy ± 10% 
Open NCT05211895
JZJX: A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib following Definitive Locoregional Treatment in Participants with Stage IB-IIIA RET fusion-Positive NSCLC (LIBRETTO-432)


  • RET fusion on PCR/NGS
  • Must have received definitive locoregional therapy
  • Max 10 weeks between local therapy and randomization
  • Max 26 weeks between adj chemo and randomization
  • Crossover possible
Open NCT04819100
KRYSTAL-7: A Phase 2 Trial of MRTX849 Monotherapy and in Combination with Pembrolizumab in Patients with Advanced NSCLC with KRAS G12C Mutation


  • KRAS G12C
  • Cohort 1: PD-L1 TPS <1%
  • Cohort 2: PD-L1 TPS ≥1% (CLOSED)
  • Unresectable or metastatic
  • Squamous or nonsquamous
Open NCT04613596
PACIFIC-4: A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab with Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with unresected Stage I/II, lymph-node negative NSCLC


  • T1 to T3N0M0
  • Medically inoperable or surgery refusal
  • Central or peripheral lesions are eligible
  • (Meta)synchronous NSCLC tumors are allowed (max 2)
  • NSCLC with sensitizing EGFRm may be eligible for osimertinib cohort:
    • osimertinib after SBRT (no durvalumab)
    • Ex19del or L858R
Open NCT03833154

Malignant Pleural Mesothelioma

1L, after induction chemotherapy and surgery
  • High-Dose RT, Lung-sparing multimodality therapy
  • R0-R1 resection
  • >18 years
  • WHO 0-2
  • DLCO > 40%
PRIMALung: PRophylactic cerebral Irradiation or active MAgnetic resonance imaging surveillance in small-cell Lung cancer patients

SCLC, any stage

after 1L
  • Stage I-IV
  • Randomization within 16 weeks after last chemo
  • Immunotherapy continuing adjuvant is allowed
  • No brain metastases and no prior brain RT
Open NCT04790253
COLIPAN: collection of liquid biopsies in pancancer patients 

NSCLC adenoCa,

NSCLC plaveiselcelCa

  • Liquid Biopsy collection new diagnoses No NET tumors 
KRYSTAL-12: A Randomized Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients with Previously Treated NSCLC with KRAS G12C Mutation


  • Prior platinum + I/O
  • Crossover possible
Open NCT04685135
Laatst aangepast: 30 maart 2023