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

Phase 3

Recruiting

• Conditions: NSCLC, Stage IIIA; EGF-R Negative Non-Small Cell Lung Cancer; ALK Negative NSCLC
• Interventions: Drug: PD-1 and chemotherapy

• Registration Number: NCT05157776
• Lead Sponsor: Tongji University

Brief 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

Detailed Description

This study is a prospective, multicenter, phase III randomized controlled clinical study. Stage IIIA NSCLC patients with EGFR mutation negative and ALK rearrangement negative were enrolled, and after 2 courses of treatment with Sintilimab combined with Platinum-based Chemotherapy, they were randomly assigned 1:1 to the control group (surgical resection and postoperative treatment for 2 courses are recommended) or the experimental group (surgery after 2 courses of treatment).

The primary endpoint is pCR rate. The second endpoints are MPR, DFS, and MRD.

Study Timeline

• Study Start: 2021-10-28
• Study First Submitted: 2021-12-07
• Study First Submitted QC: 2021-12-14
• Study First Posted: 2021-12-15
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-07
• Last Update Posted: 2023-05-09
• Primary Completion: 2024-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	PD-1 and chemotherapy	Neoadjuvant therapy of Sintilimab and chemotherapy in 2 cycles before surgery and optional adjuvant therapy of Sintilimab and chemotherapy in 2 cycles after surgery
Experimental group	PD-1 and chemotherapy	Neoadjuvant therapy of Sintilimab and chemotherapy in 4 cycles before surgery

Primary Outcome Measures

Name	Time	Method
Pathologically complete response (pCR) rate	in three weeks after the surgical resection

Secondary Outcome Measures

Name	Time	Method
Major pathological response (MPR) rate	in three weeks after the surgical resection
Disease-free survival (DFS)	one, two, three and five years since the initial treatment (each treatment is 2 days)
Minimal residual disease(MRD)	in one week before each cycle and in the forth week after the surgical resection (each cycle is 21 days)

Trial Locations

Locations (1)

Shanghai General Hospital; 🇨🇳 Shanghai, Shanghai, China