NCT06688656

Neoadjuvant Chemotherapy Sequentially Combined with Sintilimab in Resectable EGFR-Mutant NSCLC

A Phase II Single-Center Exploratory Study on the Efficacy and Safety of Neoadjuvant Chemotherapy Sequentially Combined with Sintilimab in Resectable EGFR-Mutant Stage II-IIIB Non-Squamous Non-Small Cell Lung Cancer Patients

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, single-arm, single-center Phase II trial, aiming to investigate efficacy and safety of neoadjuvant chemotherapy sequentially combined with sintilimab in resectable EGFR-mutant stage II-IIIB non-squamous NSCLC patients

Detailed description

Previous studies have confirmed the efficacy of neoadjuvant chemotherapy and immunotherapy in NSCLC patients without driver gene mutations, while their effectiveness in patients with driver gene mutations remains controversial. This study is a prospective, single-arm, single-center Phase II trial targeting eligible subjects with resectable EGFR-mutated stage II-IIIB non-squamous non-small cell lung cancer, aiming to evaluate the efficacy and safety of sintilimab combined with chemotherapy as neoadjuvant therapy. Eligible subjects who meet the inclusion criteria and have signed the informed consent will receive sintilimab in combination with chemotherapy, with a treatment cycle of 3 weeks. A tumor assessment will be conducted before the start of the third cycle of treatment, and surgery will be performed within 3-6 weeks after the last cycle of neoadjuvant therapy, with a tumor assessment conducted 7 days prior to surgery. After completing local treatment (surgery), researchers will offer optional adjuvant therapy to patients, including EGFR-TKI. Concurrently, dynamic blood samples will be collected before neoadjuvant therapy and after each treatment cycle for exploratory analysis, with the evaluation of MPR and pCR based on circulating tumor DNA minimal residual disease (ctDNA-MRD).

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Pemetrexed 500 mg/m2	1\. Pemetrexed: 500mg/m² on Day 1, Q3W, administered via intravenous infusion for a total of 3 cycles.
DRUG	carboplatin	AUC=5 on Day 1, Q3W，administered via intravenous infusion for a total of 3 cycles.
DRUG	Sintilimab	Sintilimab, 200mg, administered via intravenous infusion on the 3rd day of each cycle, Q3W, for a total of 3 cycles.

Timeline

• Start date: 2025-03-31
• Primary completion: 2026-03-31
• Completion: 2028-03-31
• First posted: 2024-11-14
• Last updated: 2024-11-14

Locations

1 site across 1 country: China