Trials / Active Not Recruiting
Active Not RecruitingNCT05908734
A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer
A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Cetrelimab Combination Therapy in Metastatic Non-small Cell Lung Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 71 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to identify the recommended Phase 2 (combination) dose (RP2CD) of the amivantamab and cetrelimab combination therapy in participants with 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 characterized on the basis of epidermal growth factor receptor (EGFR) and Programmed-cell death Ligand (PD-L)1 status, in the Phase 2 (expansion).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cetrelimab | Cetrelimab will be administered as IV infusion. |
| DRUG | Amivantamab | Amivantamab will be administered as IV infusion. |
Timeline
- Start date
- 2023-05-18
- Primary completion
- 2027-01-31
- Completion
- 2027-03-31
- First posted
- 2023-06-18
- Last updated
- 2026-03-13
Locations
43 sites across 9 countries: United States, Brazil, Italy, Malaysia, Poland, South Korea, Spain, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05908734. Inclusion in this directory is not an endorsement.