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NCT06532032CompletedPhase 1/2

A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer

61186372PANSC2003: 61186372PANSC2003 ISA#3 Platform Trial

Source: ClinicalTrials.gov · Last updated 31 Jul 2026

Brief summary (registry, in English)

The purpose of this study is to identify the recommended Phase 2 (combination) dose (RP2CD) of the amivantamab and docetaxel combination therapy in participants with metastatic non-small cell lung cancer (NSCLC) in Phase 1 (combination dose selection); and to evaluate the antitumor effect of the combination at the selected RP2CD in participants with NSCLC without oncogenic driver mutations with disease progression on platinum-based chemotherapy and immune checkpoint inhibitor, in the Phase 2 (expansion).

Status (registry)
Completed
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
12 (actual)
First submitted
29 Jul 2024
Start date
23 Jul 2024
Primary completion date
14 May 2026
Lead sponsor
Janssen Research & Development, LLC
Diseases
Lung cancer
NCT number
NCT06532032

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 12
  • From 23 Jul 2024 to the primary completion date, 14 May 2026
  • 15 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participant has received radiotherapy for palliative purposes less than 14 days prior to the first dose of study treatment
  • Participant has: a.(Or has a history of) leptomeningeal disease (carcinomatous meningitis); b. Spinal cord compression not definitively treated with surgery or radiation.

Other illness

  • Medical history of (non-infectious) ILD/pneumonitis, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening- Participant has history of any significant drug allergy (such as anaphylaxis, hepatotoxicity, or immune-mediated thrombocytopenia or anemia) or has known allergies, hypersensitivity, or intolerance to: a. amivantamab or amivantamab excipients (refer to the amivantamab IB); b.docetaxel, docetaxel excipients or to other drugs formulated with polysorbate and paclitaxel

Lab values

  • For Phase 2 only: Participant has known oncogenic driver mutations (EGFR, MET, HER2, ALK, ROS1, NTRK, BRAF, RET, or KRAS) as detected by local testing or by central ctDNA testing

Who the study is looking for

  • Participant must have histologically or cytologically confirmed NSCLC and must have metastatic NSCLC at the time of enrollment
  • Participant must have at least 1 measurable lesion, according to RECIST v1.1, that has not been previously irradiated
  • May have brain metastases only if previously definitively treated, and participant is clinically stable and asymptomatic for \>2 weeks and is off or receiving low-dose corticosteroid treatment (\<=10 mg prednisone or equivalent) for at least 2 weeks prior to start of study treatment
  • May have a prior malignancy (other than the disease under study) if the natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
  • Have an ECOG performance status of 0 or 1

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Leeds Teaching Hospitals NHS Trust
Coordinator of this site? Confirm its status
LeedsUnited KingdomUnknown status
The Royal Marsden NHS Trust
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SuttonUnited KingdomUnknown status
Changhua Christian Hospital
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ChanghuaTaiwanUnknown status
Kaohsiung Medical University Hospital
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Kaohsiung CityTaiwanUnknown status
Chi Mei Medical Center Liu Ying
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Liou Ying TownshipTaiwanUnknown status
Taichung Veterans General Hospital
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TaichungTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Taipei Medical University
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TaipeiTaiwanUnknown status
Virginia Cancer Specialists
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FairfaxUnited StatesUnknown status
Hunterdon Hematology Oncology
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FlemingtonUnited StatesUnknown status
UCI Health Irvine Hospital
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IrvineUnited StatesUnknown status
Cancer and Blood Specialty Clinic
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Los AlamitosUnited StatesUnknown status
University of California Irvine Medical Center Chao Family Comprehensive Cancer Center
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OrangeUnited StatesUnknown status
Oncology Hematology Associates
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SpringfieldUnited StatesUnknown status
Ankara Bilkent Sehir Hastanesi
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ÇankayaTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.