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A Phase III Trial of Neoadjuvant Sintilimab and Chemotherapy for NSCLC Harboring No Driver Mutations

NCT05157776 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2023-05-09

No results posted yet for this study

Summary

This is a randomized, open-label study designed to evaluate the safety and efficacy of neoadjuvant PD-1 antibody plus chemotherapy followed by surgery in resectable stage IIIA non-small cell lung cancer.

The primary endpoint: pCR rate The second endpoint: MPR, DFS, MRD

Conditions

  • NSCLC, Stage IIIA
  • EGF-R Negative Non-Small Cell Lung Cancer
  • ALK Negative NSCLC

Interventions

DRUG

PD-1 and chemotherapy

Sintilimab+(Squamous)ABX+DDP/CBP, or (non-Squamous)PEM+DDP/CBP

Sponsors & Collaborators

  • Tongji University

    lead OTHER

Principal Investigators

  • Jiang Fan, MD · Shanghai General Hospital; Shanghai Pulmonary Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-28
Primary Completion
2024-10-31
Completion
2025-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05157776 on ClinicalTrials.gov