RecruitingPhase 2NCT06241807

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

A Phase II Trial of Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB Non-Small Cell Lung Cancer


Sponsor

Shandong Cancer Hospital and Institute

Enrollment

30 participants

Start Date

Dec 2, 2022

Study Type

INTERVENTIONAL

Summary

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving camrelizumab (an immunotherapy drug) combined with chemotherapy before surgery can improve outcomes for patients with resectable stage IIIA–IIIB non-small cell lung cancer (NSCLC). Giving treatment before surgery (called neoadjuvant therapy) may shrink the tumor and improve the chance of a complete surgical removal. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed resectable stage IIIA–IIIB (T3–4N2) non-small cell lung cancer - Your tumor does NOT have EGFR, ALK, or ROS1 gene mutations - Your general health is good (ECOG status 0–1) - Your blood counts and organ function meet the required levels **You may NOT be eligible if...** - You have had prior chemotherapy or immunotherapy - You have another active cancer - You have interstitial lung disease or non-infectious pneumonia - You have an active autoimmune disease being treated with systemic medications - You have significant heart or lung dysfunction that makes surgery unsafe - You have an active infection requiring systemic treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCamrelizumab Plus Chemotherapy

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 \[cisplatin, 75 mg/m2; carboplatin, area under the curve, 5\])


Locations(1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06241807