Overview

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

Status:
Recruiting

Trial end date:
2023-10-31

Target enrollment:
0

Participant gender:
All

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

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Tongji University

Criteria

Inclusion Criteria:

1. Resectable stage IIIA NSCLC, EGFR mutation-negative and ALK rearrangement negative
(8th UICC TNM staging);

2. No prior anti-tumor therapy for NSCLC;

3. Age from 18 to 75 years old;

4. Adequate organ function:

Hemoglobin ≥9.0g/L; White blood cell count 4.0~10×109/L; The absolute value of
neutrophils (ANC) ≥ 1.5×109/L; Platelet count ≥100×109/L; Total bilirubin ≤ 1.5 times
the upper limit of normal; ALT and AST≤2.5 times the upper limit of normal; The
international normalized ratio of prothrombin time is ≤1.5 times the upper limit of
normal value, and the partial thromboplastin time is within the range of normal value;
Creatinine ≤ 1.5 times the upper limit of normal;

5. No chemotherapy, radiotherapy or hormone therapy for malignant tumors, no history of
other malignant tumors, excluding patients who have received hormone therapy for
prostate cancer and have had DFS for more than 5 years;

6. ECOG 0～1;

Exclusion Criteria:

1. Double primary or multiple primary NSCLC;

2. EGFR mutation or ALK mutation was positive

3. patients with psychosis;

4. Pre-existing or coexisting bleeding disorders;

5. Other uncontrollable and inoperable patients;

6. Patients whose previous operations have prevented this operation from being performed;

7. Female patients who are pregnant or breastfeeding;

8. For patients who are allergic to the drugs in the program.