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June 20, 2026Open Access

Neoadjuvant camrelizumab plus chemotherapy in resectable stage IIIA–IIIB non-small cell lung cancer: integrated multidimensional biomarker analysis from a phase II study

Key Points

This study aims to evaluate biomarker profiles associated with therapeutic response and prognosis in resectable NSCLC treated with neoadjuvant camrelizumab plus chemotherapy.
Conducted as a single-arm phase II trial with 30 patients diagnosed with resectable stage IIIA–IIIB NSCLC receiving three cycles of camrelizumab plus chemotherapy followed by surgery.
Primary endpoints included pathological complete response (pCR) and secondary endpoints included major pathological response (MPR) and disease-free survival (DFS).
Exploratory analyses were conducted on immune subsets in the tumor microenvironment, cytokine profiles, ctDNA dynamics, and spatial immune-tumor interactions.
The pCR rate was 33.3% and the MPR rate was 50.0%.
At a median follow-up of 27.2 months, the 2-year DFS rate was 77.4%.
Baseline levels of CD8+ T cells and proximity to tumor cells were associated with improved DFS, while ctDNA positivity predicted shorter DFS.

Abstract

Background This study evaluated biomarker profiles associated with therapeutic response and prognosis in resectable non-small cell lung cancer (NSCLC) receiving neoadjuvant camrelizumab plus chemotherapy. Methods In this single-arm phase II trial, patients with resectable stage IIIA–IIIB NSCLC received three cycles of camrelizumab plus chemotherapy, followed by surgery. Primary endpoints were pathological complete response (pCR). Secondary endpoints included major pathological response (MPR), disease-free survival (DFS), and safety. Exploratory analyses assessed immune subsets in the tumor microenvironment (TME) and peripheral blood, cytokine profiles, circulating tumor DNA (ctDNA) dynamics, and spatial immune–tumor interactions. Results Thirty patients were enrolled (22 squamous, 8 adenocarcinoma); 27 underwent radical resection. The pCR and MPR rates were 33.3% and 50.0%, respectively. At a median follow-up of 27.2 months, the 2-year DFS rate was 77.4%. Grade≥3 treatment-related adverse events occurred in 13.3%. Achieving pCR was associated with higher baseline levels of CD8+ T cells and naïve-like T cells in both blood and TME. Elevated baseline CD8+ naïve-like T cells in both peripheral blood and tumor nests and their closer proximity to tumor cells correlated with improved DFS. Higher circulating baseline chemokine (C-C motif) ligand 3 (CCL3) levels were associated with both pCR and prolonged DFS. Postneoadjuvant treatment ctDNA positivity predicted shorter DFS, while longitudinal ctDNA monitoring identified relapse as early as 17.6 months before radiographic progression. Conclusions Baseline CD8+ naïve-like T-cell abundance and spatial proximity to tumor cells, circulating CCL3 levels, and ctDNA dynamics may serve as potential prognostic biomarkers in resectable NSCLC receiving neoadjuvant camrelizumab plus chemotherapy. Trial registration number NCT06241807 .

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Cai et al. (Mon,) studied this question.

synapsesocial.com/papers/6a3631a1db0793dc1a53873c https://doi.org/https://doi.org/10.1136/jitc-2026-015604

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