OncoMatch/Clinical Trials/NCT06364917
DISCERN: Dual Versus Single ICB in PDL-1 Negative NSCLC
Is NCT06364917 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for non small cell lung cancer.
Treatment: Pembrolizumab · Carboplatin · Paclitaxel · Pemetrexed · Nivolumab · Ipilimumab — The purpose of this study, known as DISCERN, is to compare two different treatments for a type of lung cancer called non-small cell lung cancer (NSCLC) that does not show a marker known as PD-L1. This study will help us understand if using two types of immune therapy together with chemotherapy is better than using one type of immune therapy with chemotherapy. We're doing this by looking at changes in the subject's cancer's DNA in the blood after starting treatment.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Biomarker criteria
Required: EGFR sensitizing mutation (wild-type)
Participants should not have a known sensitizing mutation for which an FDA-approved targeted therapy for NSCLC exists in first line (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, and MET sensitizing mutations
Required: ALK sensitizing mutation (wild-type)
Participants should not have a known sensitizing mutation for which an FDA-approved targeted therapy for NSCLC exists in first line (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, and MET sensitizing mutations
Required: ROS1 sensitizing mutation (wild-type)
Participants should not have a known sensitizing mutation for which an FDA-approved targeted therapy for NSCLC exists in first line (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, and MET sensitizing mutations
Required: BRAF sensitizing mutation (wild-type)
Participants should not have a known sensitizing mutation for which an FDA-approved targeted therapy for NSCLC exists in first line (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, and MET sensitizing mutations
Required: RET sensitizing mutation (wild-type)
Participants should not have a known sensitizing mutation for which an FDA-approved targeted therapy for NSCLC exists in first line (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, and MET sensitizing mutations
Required: NTRK1 sensitizing mutation (wild-type)
Participants should not have a known sensitizing mutation for which an FDA-approved targeted therapy for NSCLC exists in first line (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, and MET sensitizing mutations
Required: NTRK2 sensitizing mutation (wild-type)
Participants should not have a known sensitizing mutation for which an FDA-approved targeted therapy for NSCLC exists in first line (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, and MET sensitizing mutations
Required: NTRK3 sensitizing mutation (wild-type)
Participants should not have a known sensitizing mutation for which an FDA-approved targeted therapy for NSCLC exists in first line (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, and MET sensitizing mutations
Required: MET sensitizing mutation (wild-type)
Participants should not have a known sensitizing mutation for which an FDA-approved targeted therapy for NSCLC exists in first line (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, and MET sensitizing mutations
Required: PD-L1 (CD274) expression <1% or negative (<1%)
tumor tissue...which have been determined as PD-L1 status <1% or negative prior to randomization
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic anticancer therapy
Exception: Patients who are recently diagnosed and received one cycle of chemotherapy while awaiting NGS/PDL-1 testing are allowed on study after discussion with medical monitor.
Participants should not have received prior systemic anticancer therapy for advanced or metastatic disease. For patients who are recently diagnosed and received one cycle of chemotherapy while awaiting NGS/PDL-1 testing are allowed on study after discussion with medical monitor.
Cannot have received: anti-PD-1 therapy
Prior treatment or history of allergy/hypersensitivity with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or other specific T-cell co-stimulation or checkpoint targeting drugs.
Cannot have received: anti-PD-L1 therapy
Prior treatment or history of allergy/hypersensitivity with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or other specific T-cell co-stimulation or checkpoint targeting drugs.
Cannot have received: anti-PD-L2 therapy
Prior treatment or history of allergy/hypersensitivity with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or other specific T-cell co-stimulation or checkpoint targeting drugs.
Cannot have received: anti-CTLA-4 therapy
Prior treatment or history of allergy/hypersensitivity with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or other specific T-cell co-stimulation or checkpoint targeting drugs.
Cannot have received: checkpoint inhibitor
Prior treatment or history of allergy/hypersensitivity with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or other specific T-cell co-stimulation or checkpoint targeting drugs.
Lab requirements
Blood counts
adequate organ function to be able to safely receive the approved standard of care regimens per the current FDA approved package insert, treating investigators discretion and institutional guidelines
Kidney function
adequate organ function to be able to safely receive the approved standard of care regimens per the current FDA approved package insert, treating investigators discretion and institutional guidelines
Liver function
adequate organ function to be able to safely receive the approved standard of care regimens per the current FDA approved package insert, treating investigators discretion and institutional guidelines
adequate organ function to be able to safely receive the approved standard of care regimens per the current FDA approved package insert, treating investigators discretion and institutional guidelines
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham · Birmingham, Alabama
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