Abstract 609P
Background
Adjuvant immunotherapy has been considered as a standard treatment for early-stage NSCLC. However, the timing of adding immune checkpoint inhibitors is still deserved to be further inquired. Therefore, this study aimed to explore the efficacy and safety of camrelizumab combined with platinum doublet chemotherapy as adjuvant treatment for stage IIA-IIIA NSCLC.
Methods
In this phase II, single-arm study, 30 patients with pathologically confirmed stage IIA or IIIA NSCLC according to the AJCC (8th edition) who had achieved R0 resection were enrolled. Eligible patients were aged 18 years or older, ECOG PS of 0 or 1, without EGFR/ALK alterations and had not received neoadjuvant radiotherapy or chemotherapy. After complete resection, patients received 4 cycles of platinum doublet chemotherapy and camrelizumab (Q3W) until disease progression, unacceptable toxicity, or completion up to 17 cycles of treatment. The primary endpoint is 12-month DFS rate while the secondary endpoints are 36-month DFS rate, DFS, overall survival and safety.
Results
Up to July 15, 2024, 25 patients were enrolled with a median age of 59 years (range, 48-75 years). 72% of the patients were male, and 32% were smokers. The histological subtypes were as follows: 7 patients had adenocarcinoma, 16 had squamous cell carcinoma, and 2 had carcinosarcoma. As of data cutoff, 18 patients had completed treatment, while 7 patients were still on treatment. No negative impact of surgery on adjuvant therapy was observed. The median follow-up duration was 447 days. The median cycle of camrelizumab was 8 (range 3 -17). The 12-month DFS rate was 94.44%. During the course of adjuvant therapy, the grade 3 or worse treatment-related adverse events were anemia (4%). Common grade 1-2 adverse reactions included RCCEP (72%), nausea (48%), sensory neuropathy (40%). The treatment was well tolerated and no toxic death occurred. All the adverse events can be controlled and alleviated after symptomatic treatment.
Conclusions
Camrelizumab combined with platinum doublet chemotherapy may disproportionately improve early-stage NSCLC outcomes following curative-intent resection. This encouraging result promoted us to continue this phase II study.
Clinical trial identification
ChiCTR2100053236.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.