CompletedPhase 1/2

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

United States, Taiwan, Turkey (Türkiye)12 participantsStarted 2024-07-23

Plain-language summary

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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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. * 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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this is a Phase 1/Phase 2 trial combining amivantamab with docetaxel, and the first phase was specifically focused on measuring safety and dose-limiting toxicities, what do the early safety findings suggest about the risk profile of this combination compared to docetaxel alone for my situation?
2The trial has already completed recruitment — does that mean results or data might be available soon, and could my doctor access any preliminary findings to help us understand whether this combination showed meaningful tumor response rates in people with metastatic non-small cell lung cancer like mine?
3Docetaxel is an established chemotherapy drug — would my doctor recommend I try docetaxel on its own as a standard treatment first, or is there a reason combining it with amivantamab might be worth considering for my specific cancer profile?
4Since this trial measured 'objective response rate' as its main Phase 2 goal, can my doctor help me understand what that means in practical terms — like whether tumors actually shrank — and how that compares to what I might expect from other available options?
5Given that this trial is now completed and no longer enrolling, are there any currently open trials or approved treatments involving amivantamab or similar targeted therapies that my doctor thinks would be worth exploring for my case?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Phase 1: Number of Participants with Adverse events (AEs) by Severity

Timeframe: Up to 1 year 4 months

Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs)

Timeframe: Up to 21 days

Phase 2: Objective Response Rate (ORR)

Timeframe: Up to 1 year 4 months

Trial details

NCT IDNCT06532032

SponsorJanssen Research & Development, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-29

View on ClinicalTrials.gov More Carcinoma, Non-Small-Cell Lung trials