Pure Global

A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer - Trial NCT05908734

Access comprehensive clinical trial information for NCT05908734 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by Janssen Research & Development, LLC and is currently Recruiting. The study focuses on Carcinoma, Non-Small-Cell Lung. Target enrollment is 20 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

Free Database
Powered by Pure Global AI
840K+ Trials
NCT05908734
Phase 1/2
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05908734
View on ClinicalTrials.gov
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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

Study Focus

Cetrelimab

Interventional

drug

Sponsor & Location

Janssen Research & Development, LLC

Fairfax,Seoul,Seoul,Kuala Lumpur,Kuching, Malaysia,South Korea,United States of America

Timeline & Enrollment

Phase 1/2

May 18, 2023

Sep 28, 2025

20 participants

Primary Outcome

Phase 1: Number of Participants with Adverse events (AEs) by Severity,Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs),Phase 2: Objective Response Rate

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 by
 epidermal growth factor receptor (EGFR) exon19del or exon 21 leucine 858 to arginine
 substitution (L858R) mutations, who have progressed on or after prior standard of care
 therapy with a 3rd generation tyrosine kinase inhibitor (TKI) and platinum-based
 chemotherapy, in the Phase 2 (expansion).

ICD-10 Classifications

Carcinoma in situ: Bronchus and lung
Secondary malignant neoplasm of lung
Malignant neoplasm: Lower lobe, bronchus or lung
Malignant neoplasm: Bronchus or lung, unspecified
Malignant neoplasm of bronchus and lung

Data Source

ClinicalTrials.gov

NCT05908734

Non-Device Trial