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

Sponsor
Shandong Cancer Hospital and Institute
Study ID
NCT06241807
Phase
PHASE2
Status
Recruiting
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Conditions

  • Biomarkers / Blood
  • IMMUNOTHERAPY
  • Neoadjuvant Therapy
  • Resectable Lung Non-Small Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab Plus Chemotherapy — DRUG
    Patients were assigned to receive 3 cycles of camrelizumab (200 mg) plus chemotherapy (nab-paclitaxel, 130 mg/m2 or pemetrexed (for adenocarcinoma), 500mg/m2 plus platinum \[cisplatin, 75 mg/m2; carboplatin, area under the curve, 5\])

Study Details

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.

Key Dates

Start date
Dec 2, 2022
Status verified
Feb 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab Plus Chemotherapy Arm
    Patients were assigned to receive 3 cycles of camrelizumab (200 mg) plus chemotherapy (nab-paclitaxel, 130 mg/m2 or pemetrexed (for adenocarcinoma), 500mg/m2 plus platinum \[cisplatin, 75 mg/m2; carboplatin, area under the curve, 5\])

Primary Outcome Measure

Major Pathological Response Rate [ Time Frame: From date of surgery to 14 days later ]

Central Contacts

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