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

NCT ID: NCT05157776

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-28
• Study Completion Date: 2025-10-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Neoadjuvant therapy of Sintilimab and chemotherapy in 2 cycles before surgery and optional adjuvant therapy of Sintilimab and chemotherapy in 2 cycles after surgery

Group Type: ACTIVE_COMPARATOR

PD-1 and chemotherapy

Intervention Type: DRUG

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

Experimental group

Neoadjuvant therapy of Sintilimab and chemotherapy in 4 cycles before surgery

Group Type: EXPERIMENTAL

PD-1 and chemotherapy

Intervention Type: DRUG

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

Interventions

PD-1 and chemotherapy

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji University

OTHER

Sponsor Role: lead

Responsible Party

Jiang Fan

Director of Department of Thoracic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiang Fan, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai General Hospital; Shanghai Pulmonary Hospital

Locations

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiang Fan, MD

Role: CONTACT

fan_jiang@tongji.edu.cn

15901013210

Dong Lin, MD

Role: CONTACT

dlin2014@126.com

18121299433

Facility Contacts

Jiang Fan, MD

Role: primary

fan_jiang@tongji.edu.cn

02163240090

References

Lin D, Wu L, Wang P, Li X, Wang X, Cai Y, Xiong K, Chen X, Yang F, Huang W, Wang X, Fan J. Dynamic circulating tumor DNA indicates pathological benefits of additional neoadjuvant chemoimmunotherapy courses for locally advanced non-small-cell lung cancer patients. Front Oncol. 2025 Jul 24;15:1563315. doi: 10.3389/fonc.2025.1563315. eCollection 2025.

Reference Type: DERIVED

PMID: 40777124 (View on PubMed)

Other Identifiers

SGHDOT 21-10

Identifier Type: -

Identifier Source: org_study_id