Last updated 15 days ago
A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer
75 patients around the world
Available in Brazil, United States
Janssen Research & Development, LLC
1Research sites
75Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Participant must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) (any histology), and must have metastatic NSCLC at the time of enrollment:Phase 1 (Combination Dose Selection) Cohort; Metastatic NSCLC progressed on or after standard of care systemic anti-cancer therapy and participant is declining other systemic treatment options, if any.Participants without known mutations must have had disease progression on, or have intolerance to, prior platinum-based chemotherapy and PD-(L)1-targeted immunotherapy given concurrently or sequentially,OR Participants with NSCLC characterized by known driver mutations must have had disease progression on, or have intolerance to, appropriate targeted therapies as per local standard of care. Participants may have received prior therapy with amivantamab as long as discontinuation was not due to toxicity. Participants with EGFR mutation must not have had an anti-PD-1/PD-L1 therapy.Phase 2 Expansion Cohorts;Cohort A: Participant's tumor must have an EGFR exon19del or L858R mutation, as determined by local molecular testing,Cohort B: Participants must have tumors lacking known primary driver mutations and must have PD-L1 expression of greater than or equal to (>=)50 percentage (%), per local testing, and are treatment-naïve in the metastatic settingParticipant must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, that has not been previously irradiatedHave an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Participant has an uncontrolled illness, including but not limited to:a. Uncontrolled diabetes,b. Ongoing or active infection (includes infection requiring treatment with antimicrobial therapy [participants will be required to complete antibiotics 1 week prior to starting study treatment] or diagnosed or suspected viral infection),c. Active bleeding diathesis,d. Impaired oxygenation requiring continuous oxygen supplementation,e. Psychiatric illness or any other circumstances (including social circumstances) that would limit compliance with study requirementsMedical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screeningHas an active autoimmune disease or a documented history of autoimmune disease that requires systemic steroids or immunosuppressive agentsParticipant has received radiotherapy for palliative purposes less than 14 days prior to the first dose of study treatmentParticipant hasa. (or has a history of) leptomeningeal disease (carcinomatous meningitis),b. spinal cord compression not definitively treated with surgery or radiation
Sites
Fundação Antônio Prudente - CAPEC - Centro de Apoio à Pesquisa Clínica
Recruiting
StudyPolyDamas
SponsorJanssen Research & Development, LLC
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05908734
