Trial results for a Phase 2 study (NCT04623775) investigating relatlimab plus nivolumab in combination with chemotherapy for Stage IV or recurrent non-small cell lung cancer (NSCLC) were posted on ClinicalTrials.gov on 2025-03-18. The study found that the combination achieved an overall response rate (ORR) of 50.6%, compared to 43.0% for nivolumab plus chemotherapy alone.
Background
The study aimed to evaluate the safety profile and overall response rate of relatlimab plus nivolumab in combination with platinum doublet chemotherapy (PDCT) as a first-line treatment for participants with previously untreated Stage IV or recurrent non-small cell lung cancer (NSCLC).
Trial design
The study (NCT04623775) was a Phase 2 trial that enrolled 468 participants with Stage IV or recurrent non-small cell lung cancer (NSCLC). The trial compared two treatment arms: relatlimab plus nivolumab in combination with platinum doublet chemotherapy (PDCT) (Treatment C/A) versus nivolumab in combination with PDCT (Treatment D/B). The chemotherapy regimens included carboplatin, cisplatin, and paclitaxel. The study's objectives included assessing the safety profile and determining if the triple combination improved overall response rate (ORR).
Key results
Key results from the trial include:
- For Overall Response Rate (ORR) per RECISTS v1.1 by BICR in Part 2:
- Part 2: Treatment C (relatlimab plus nivolumab in combination with chemotherapy) showed an ORR of 50.6 Percentage of Participants.
- Part 2: Treatment D (nivolumab in combination with chemotherapy) showed an ORR of 43.0 Percentage of Participants.
- An Odds Ratio (OR) for ORR of 1.39 (90.0% CI: 0.94 to 2.05) was calculated using the Cochran-Mantel-Haenszel method.
- Regarding treatment-related adverse events (TRAEs) leading to discontinuation within 12 weeks of the first dose in Part 1:
- Part 1: Treatment A (relatlimab plus nivolumab in combination with chemotherapy) reported 5.6 Percentage of Participants.
- Part 1: Treatment B (nivolumab in combination with chemotherapy) reported 12.1 Percentage of Participants.
- The Risk Difference (RD) for TRAEs leading to discontinuation was -6.5 (95.0% CI: -16.0 to 3.0).
- The total number of participants with any treatment-related AE in Part 1 was 75 Participants for Treatment A and 76 Participants for Treatment B.
What this means
The results suggest that the combination of relatlimab plus nivolumab with chemotherapy may offer an improved overall response rate compared to nivolumab plus chemotherapy alone in patients with Stage IV or recurrent NSCLC. Additionally, the lower percentage of treatment-related adverse events leading to discontinuation within 12 weeks for the triple combination suggests a potentially manageable safety profile in the initial treatment phase. These findings contribute to the understanding of combination immunotherapies in advanced lung cancer.
Source
The information for these trial results was sourced from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04623775, titled "A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)," were posted on 2025-03-18 on clinicaltrials.gov.