Camrelizumab combined with 2 cycles of chemotherapy as first-line treatment for advanced non-small cell lung cancer (NSCLC): A two-arm, single-center, phase 2 study.

Abstract

8548 Background: In the treatment of advanced non-small cell lung cancer (NSCLC), the combination of anti-PD1 and chemotherapy has demonstrated an advantage over chemotherapy alone. First-line treatment of advanced NSCLC with camrelizumab in combination with platinum-based chemotherapy shows promising clinical activity. Nonetheless, the impact of varying chemotherapy cycles on efficacy and safety requires investigation through data from prospective studies. Methods: This was a two-arm, single-center, phase 2 clinical trial (ChiCTR2200065078) in which we assigned patients with stage IIIb-IV advanced non-small cell lung cancer (NSCLC) to receive 2 or 4 cycles of platinum-based chemotherapy combined with camrelizumab 200 mg, followed by camrelizumab maintenance therapy until 2 years. The primary endpoint was progression-free survival, and secondary endpoints were objective response rate (ORR), overall survival (OS) and safety. Results: As of December 1, 2024, 40 patients were enrolled in this study, including 16 patients in the 2-cycle platinum-based chemotherapy combined with camrelizumab groups (Group A), and 24 patients in the 4-cycle platinum-based chemotherapy combined with camrelizumab groups (Group B) with a median follow-up of 17.6 months. The patients in Group A are older than those in Group B (75.50 [72.75, 77.25] vs. 69.00 [63.75, 72.25]). The median progression-free survival (PFS) were 5.4 months (95% CI, 4.9 to 5.9) for the group A and 13.0 months (95% CI, 5.6 to 20.4) for the group B, respectively (P=0.195). The confirmed overall response (ORR) was 6.2%, (95% CI, 0.6% to 26.4%) for the Group A and 41.7%, (95% CI, 20.7% to 65.9%) for the Group B, respectively (P=0.036). The median OS were 11.4 months (95% CI, 8.6 to 14.2) for the group A and 24.1 months (95% CI, 17.4 to 30.8) for the Group B, respectively (P=0.079). Across the overall population, 97.5% of patients reported any grade of treatment-related adverse event (TRAE), with 6.2% experiencing grade ≥3 TRAEs for Group A, and 12.5% for Group B. Conclusions: The 2-cycle group did not show superior progression-free survival (PFS) relative to the 4-cycle platinum-based chemotherapy when combined with camrelizumab. However, the 4-cycle platinum-based chemotherapy group may have resulted in a higher probability of developing grade ≥3 treatment-related adverse events. A combination of a 2-cycle chemotherapy and immunotherapy may be more suitable for elderly patients with advanced lung cancer. Clinical trial information: ChiCTR2200065078 .