TRIPL: Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer

NCT06865339 Phase 2 RECRUITING

Determine anti-tumor efficacy by characterizing response rates on positron emission tomography (PET) following three cycles of induction immunotherapy with cemiplimab and fianlimab without chemotherapy for locally advanced non-small cell lung cancer (LA-NSCLC).

Details

Lead sponsor	Montefiore Medical Center
Phase	Phase 2
Status	RECRUITING
Enrolment	76
Start date	2025-08-07
Completion	2027-08

Conditions

• NSCLC
• Locally Advanced

Interventions

• Cemiplimab
• Fianlimab
• Radiotherapy
• Platinum Doublet Chemotherapy (PDC)

Primary outcomes

• Objective Response Rate (ORR) to induction IO therapy — Following 3 cycles (each cycle is ~3 weeks) of induction IO therapy, approximately 10 weeks overall
  ORR to induction therapy will be evaluated by fluorodeoxyglucose (FDG) FDG-PET scan using Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) criteria. Pre-and post-treatment maximum standardized uptake value (SUV) levels following PERCIST criteria will be assessed. Specifically, the percentage of patients who experience either a complete metabolic response (CMR) or partial metabolic response (PMR) based on changes in FDG uptake will be determined and quantified using the following calculation (PMR+CMR/Sample Size). All participants who initiate study therapy will be analyzed for ORR. Participants who do not undergo response rate evaluation for any reason will be categorized as non-responders. Response rates in each study cohort will be summarized and reported using counts and percentages. 95% Clopper-Pearson confidence intervals will be calculated. ORR based on PET are more accurate predictors of long-term clinical outcomes than computed tomography (CT).

Countries

United States