RecruitingPhase 2NCT04728724

Neoadjuvant Immunotherapy for Stage III Non-small Cell Lung Cancer

Neoadjuvant Sintilimab or Combined With Chemotherapy for Stage III Driven Gene Mutation Negative Non-small Cell Lung Cancer

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Enrollment

100 participants

Start Date

Sep 10, 2022

Study Type

INTERVENTIONAL

Conditions

Non-Small Cell Lung Cancer (Stage III)

Summary

This is a phase II, non-randomized, open-label, multi-center study to evaluate the efficacy of neoadjuvant Sintilimab (PD-1 antibody) or combined with chemotherapy as first-line treatment in patients with stage III non-small cell lung cancer (NSCLC).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving immunotherapy (a drug called sintilimab) along with chemotherapy before surgery helps shrink stage III non-small cell lung cancer (NSCLC) and improves the chances of successful surgical removal. **You may be eligible if:** - You are 18 or older - You have stage III NSCLC confirmed by biopsy and imaging - Your cancer is considered potentially resectable (removable by surgery) - Your overall health and organ function are adequate - You have at least one measurable tumor lesion - You are willing to use contraception during and after treatment **You may NOT be eligible if:** - Your non-squamous cancer has EGFR mutations or ALK rearrangement (different targetable mutations) - You have received prior cancer treatment for this tumor - Your cancer has already spread distantly - You have had prior major surgery within the past 4 weeks - You are pregnant or breastfeeding - You have had prior pneumonitis requiring steroids 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.

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Interventions

DRUGSintilimab

Neoadjuvant treatment stage: Sintilimab 200mg, q3w, i.v., 2-4 cycles, then receive chest CT evaluation. Surgery stage: the patients will receive radical surgery after the neoadjuvant treatment. Adjuvant treatment stage: according to the NCCN guidelines.

DRUGChemotherapy

Neoadjuvant treatment stage: Sintilimab 200mg, q3w, i.v., 2-4 cycles; platinum-based chemotherapy (Non-squamus: Carboplatin AUC 5 + Pemetrexed 500mg/m2; Squamous: Carboplatin AUC 5 + Gemcitabine 1000mg/m2 or Paclitaxel 200mg/m2) q3w, i.v., 2-4 cycles, then receive chest CT evaluation. Surgery stage: the patients will receive radical surgery after the neoadjuvant treatment. Adjuvant treatment stage: according to the NCCN guidelines.