A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer
NCT06532032 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2026-04-13
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).
Conditions
- Carcinoma, Non-Small-Cell Lung
Interventions
- DRUG
-
Amivantamab will be administered as IV infusion.
- DRUG
-
Docetaxel will be administered as IV infusion.
Sponsors & Collaborators
-
Janssen Research & Development, LLC
lead INDUSTRY
Principal Investigators
-
Janssen Research &Development, LLC Clinical Trial · Janssen Research & Development, LLC
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-23
- Primary Completion
- 2026-05-29
- Completion
- 2026-06-09
- FDA Drug
- Yes
Countries
- United States
- Taiwan
- Turkey (Türkiye)
- United Kingdom
Study Locations
More Related Trials
-
A Study of the Efficacy and Safety of MetMAb Combined With Tarceva in Patients With Met-Positive Non-Small Cell Lung Cancer
NCT02031744 ·Status: COMPLETED ·Phase: PHASE3
-
Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced Non-Small Cell Lung Cancer
NCT00193453 ·Status: COMPLETED ·Phase: PHASE2
-
Phase I/II Study of Nivolumab and Ipilimumab Combined With Nintedanib in Non Small Cell Lung Cancer
NCT03377023 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
S0119: Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
NCT00030433 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Vantictumab (OMP-18R5) in Combination With Docetaxel in Patients With Previously Treated NSCLC
NCT01957007 ·Status: COMPLETED ·Phase: PHASE1
-
Trilaciclib in Combination With Docetaxel for Second-Line and Beyond Treatment of Locally Advanced or Metastatic NSCLC
NCT06929936 ·Status: RECRUITING ·Phase: PHASE2
-
A Study Evaluating the Efficacy and the Safety of First-line Chemotherapy Combined With the Therapeutic Vaccine Named TG4010 and Nivolumab in Patients With Advanced Non-squamous Non-Small Cell Lung Cancer (NSCLC)
NCT03353675 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 2 Study of Anvumetostat in Participants With MTAP-deleted Advanced NSCLC (MTAPESTRY 201)
NCT06593522 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions
NCT04538664 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Combination Chemotherapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
NCT00054392 ·Status: WITHDRAWN ·Phase: PHASE3
-
CM082 and JS001 in Patients With Advanced Small-cell Lung Cancer (SCLC)
NCT03904719 ·Status: UNKNOWN ·Phase: PHASE2
-
Docetaxel in Non Small Cell Lung Cancer (NSCLC)
NCT00258739 ·Status: COMPLETED ·Phase: PHASE2
-
Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has Increased Copies of the MET Gene (An Expanded Lung-MAP Treatment Trial)
NCT06116682 ·Status: RECRUITING ·Phase: PHASE2
-
A Study Evaluating the Efficacy of PD-1 Inhibitor Combined With Denosumab and Chemotherapy in Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Patients With Driver Gene-Negative Status
NCT07034391 ·Status: RECRUITING ·Phase: PHASE2
-
Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung Cancer
NCT00065182 ·Status: COMPLETED ·Phase: PHASE2
-
Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery
NCT00004253 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer
NCT01703091 ·Status: COMPLETED ·Phase: PHASE2
-
SHR1020 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Squamous Non Small Cell Lung Cancer
NCT02766140 ·Status: TERMINATED ·Phase: PHASE3
-
Trial of Weekly Taxotere and Irinotecan (CPT-11) in Patients With Advanced Non-small Cell Lung Cancer
NCT00819728 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
NCT05498428 ·Status: RECRUITING ·Phase: PHASE2
-
Taxotere Combinations as First Line Therapy for Locally Advanced Unresectable or Metastatic Non-small Cell Lung Cancer.
NCT00425191 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 2, Open-Label Study of Amuvatinib in Combination With Platinum-Etoposide Chemotherapy in Small Cell Lung Cancer
NCT01357395 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of MetMAb Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib)
NCT00854308 ·Status: COMPLETED ·Phase: PHASE2
-
Phase II Study of Platinum (Cisplatin/Carboplatin)and Polymeric Micelles Paclitaxel(Pm-Pac) With Ivonescimab in First Line Metastatic Squamous NSCLC.
NCT07009925 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Envafolimab Plus Docetaxel In Combination With or Without Trilaciclib Versus Docetaxel in Advanced NSCLC
NCT05910034 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2