Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB NSCLC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShandong Cancer Hospital and Institute

About this trial

This study aims to evaluate the efficacy and safety of neoadjuvant camrelizumab combined with chemotherapy in resectable stage IIIA and IIIB (T3-4N2) non-small cell lung cancer (NSCLC) patients. Inclusion criteria are: age 18-75, pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC, absence of EGFR, ALK, and ROS1 gene mutations, and Eastern Cooperative Oncology Group (ECOG) status 0-1. All patients receive three cycles of camrelizumab combined with platinum-based doublet chemotherapy, followed by curative surgery within 4-6 weeks after completion of chemotherapy. Patients undergo 18F-fluorodeoxyglucose (FDG) PET/CT scans in 1 week before treatment and 1 week before surgery, and peripheral blood samples are collected for biomarker analysis. The primary endpoints for follow-up are pathologic complete response (pCR) rate and major pathological response (MPR) rate, while secondary endpoints include safety and progression-free survival. Exploratory endpoints include molecular imaging research and biomarker analysis.

Eligibility criteria

Qualifiers

Age 18-75

Pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC

Absence of EGFR, ALK, and ROS1 gene mutations

Eastern Cooperative Oncology Group (ECOG) status 0-1

Disqualifiers

Patients diagnosed with any other malignant tumor

Have received prior therapy with chemotherapy or immune checkpoint inhibitor

Insufficient caloric and/or fluid intake despite consultation with a dietitian and/or tube feeding

Have an active infection requiring systemic therapy that has not resolved 3 days (simple infection, such as cystitis) to 7 days (severe infection, such as pyelonephritis) before the first dose of trial treatment

Trial design

Treatments tested in this trial

  • Camrelizumab Plus Chemotherapy

Treatment groups

30 Participants
are divided into 1 treatment group