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
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Leeds Teaching Hospitals NHS Trust Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| The Royal Marsden NHS Trust Coordinator of this site? Confirm its status | Sutton | United Kingdom | Unknown status |
| Changhua Christian Hospital Coordinator of this site? Confirm its status | Changhua | Taiwan | Unknown status |
| Kaohsiung Medical University Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Chi Mei Medical Center Liu Ying Coordinator of this site? Confirm its status | Liou Ying Township | Taiwan | Unknown status |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Medical University Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Virginia Cancer Specialists Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| Hunterdon Hematology Oncology Coordinator of this site? Confirm its status | Flemington | United States | Unknown status |
| UCI Health Irvine Hospital Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| Cancer and Blood Specialty Clinic Coordinator of this site? Confirm its status | Los Alamitos | United States | Unknown status |
| University of California Irvine Medical Center Chao Family Comprehensive Cancer Center Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Oncology Hematology Associates Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Ankara Bilkent Sehir Hastanesi Coordinator of this site? Confirm its status | Çankaya | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.