WCLC 2025 - Posters & ePosters-P1.11.13 A Phase II Study of Camrelizumab Plus Docetaxol in Advanced NCSLC Pre-Treated With Immune Checkpoint Inhibitors and Chemotherapy

P1.11.13 A Phase II Study of Camrelizumab Plus Docetaxol in Advanced NCSLC Pre-Treated With Immune Checkpoint Inhibitors and Chemotherapy

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This phase II multicenter prospective study (ChiCTR2200065477) evaluated the efficacy and safety of camrelizumab combined with docetaxel as a second-line treatment in advanced non-small cell lung cancer (NSCLC) patients who progressed after first-line immune checkpoint inhibitors (ICI) plus chemotherapy. The regimen administered was camrelizumab (200 mg IV every 3 weeks) and docetaxel (75 mg/m² IV every 3 weeks). The primary endpoint was progression-free survival (PFS), with secondary endpoints including overall survival (OS), objective response rate (ORR), and treatment-related adverse events (TRAEs).<br /><br />Results from 22 patients (data cut-off March 31, 2025) showed an ORR of 11.8% and a disease control rate (DCR) of 75.5%. Median PFS was 4.0 months (95% CI: 0.45-7.55), while median OS was not reached at data cut-off. Patients who developed reactive cutaneous capillary endothelial proliferation (RCCEP, n=13) had significantly longer survival (median PFS 6.0 months) compared to those without RCCEP (median PFS 1.9 months; HR 0.358, p=0.046). Among 16 patients with PD-L1 tumor proportion score (TPS) data, those with TPS ≥50% (n=5) had a markedly better median PFS of 12.1 months versus 1.9 months for TPS <50% (n=11). No significant differences in outcomes were observed between squamous vs. non-squamous histology or initial response types (partial response vs stable disease).<br /><br />The most common TRAEs were fatigue (72.7%) and RCCEP (59.1%). Grade ≥3 adverse events primarily included decreased white blood cell and neutrophil counts (both 31.8%).<br /><br />In conclusion, camrelizumab plus docetaxel shows promise as a viable second-line strategy for advanced NSCLC patients progressing after frontline ICIs and chemotherapy, especially for patients with high PD-L1 expression or RCCEP development. However, the small sample size warrants larger studies to validate these findings. The study was supported by multiple Chinese oncology research grants and foundations.

Asset Subtitle

Jin Zhou

Meta Tag

Speaker Jin Zhou

Topic Metastatic Non-small Cell Lung Cancer – Immunotherapy

Keywords

camrelizumab

docetaxel

non-small cell lung cancer

NSCLC

second-line treatment

immune checkpoint inhibitors

progression-free survival

PD-L1 tumor proportion score

reactive cutaneous capillary endothelial proliferation

treatment-related adverse events