DISCERN: Dual Versus Single ICB in PDL-1 Negative NSCLC

PHASE2RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

May 30, 2025

Primary Completion Date

April 27, 2027

Study Completion Date

September 30, 2027

Conditions
Non Small Cell Lung Cancer
Interventions
DRUG

Pembrolizumab

The dosing regimens for Pembrolizumab (200 mg Q3W), are based on established FDA-approved dosages for the treatment of NSCLC, ensuring a balance between efficacy and tolerability. These doses are selected based on extensive clinical experience indicating optimal response rates with manageable safety profiles in the target population. The route of administration (intravenous) is chosen for its direct delivery into the bloodstream, ensuring maximum bioavailability and consistency of dosing.

DRUG

Carboplatin

The combination therapy dosages for Carboplatin are aligned with standard chemotherapy protocols for NSCLC, tailored to minimize toxicity while maintaining therapeutic efficacy. This dosing strategy is justified by previous phase 3 trials demonstrating the effectiveness and safety of these regimens in advanced NSCLC patients.

DRUG

Paclitaxel

The combination therapy dosages for Paclitaxel are aligned with standard chemotherapy protocols for NSCLC, tailored to minimize toxicity while maintaining therapeutic efficacy. This dosing strategy is justified by previous phase 3 trials demonstrating the effectiveness and safety of these regimens in advanced NSCLC patients.

DRUG

Pemetrexed

The combination therapy dosages for Pemetrexed are aligned with standard chemotherapy protocols for NSCLC, tailored to minimize toxicity while maintaining therapeutic efficacy. This dosing strategy is justified by previous phase 3 trials demonstrating the effectiveness and safety of these regimens in advanced NSCLC patients.

DRUG

Nivolumab

The dosing regimens for Nivolumab (360 mg Q3W) are based on established FDA-approved dosages for the treatment of NSCLC, ensuring a balance between efficacy and tolerability. These doses are selected based on extensive clinical experience indicating optimal response rates with manageable safety profiles in the target population. The route of administration (intravenous) is chosen for its direct delivery into the bloodstream, ensuring maximum bioavailability and consistency of dosing.

DRUG

Ipilimumab

The dosing regimens for Ipilimumab (1 mg/kg Q6W) are based on established FDA-approved dosages for the treatment of NSCLC, ensuring a balance between efficacy and tolerability. These doses are selected based on extensive clinical experience indicating optimal response rates with manageable safety profiles in the target population. The route of administration (intravenous) is chosen for its direct delivery into the bloodstream, ensuring maximum bioavailability and consistency of dosing.

Trial Locations (1)

35294

RECRUITING

University of Alabama at Birmingham, Birmingham

All Listed Sponsors
lead

University of Alabama at Birmingham

OTHER

NCT06364917 - DISCERN: Dual Versus Single ICB in PDL-1 Negative NSCLC | Biotech Hunter | Biotech Hunter