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NCT05908734

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
Janssen Research & Development, LLC·Phase 1/2·ClinicalTrials.gov·drugRecruiting
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Study focus
Disease/Condition
Carcinoma, Non-Small-Cell Lung
Drug/Device/Intervention
Cetrelimab
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Janssen Research & Development, LLC
Location
Fairfax,Seoul,Seoul,Kuala Lumpur,Kuching, Malaysia,South Korea,United States of America
Timeline & enrollment
Phase
Phase 1/2
Start date
May 18, 2023
End date
Sep 28, 2025
Enrollment
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 lungSecondary malignant neoplasm of lungMalignant neoplasm: Lower lobe, bronchus or lungMalignant neoplasm: Bronchus or lung, unspecifiedMalignant neoplasm of bronchus and lung
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05908734
Type
Non-Device Trial
About this record

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.