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

NSCLC, Stage IIIA Clinical Trial

Official title:

Neoadjuvant Sintilimab and Platinum-based Chemotherapy for Resectable Locally Advanced NSCLC Harboring no Driver Mutations: A Prospective, Randomized, Multicenter Phase III Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05157776
• Other study ID #: SGHDOT 21-10
• Status: Recruiting
• Phase: Phase 3
• Start date: October 28, 2021
• Est. completion date: October 31, 2025

Study information

• Verified date: May 2023
• Source: Tongji University
• Contact: Jiang Fan, MD
• Phone: 15901013210
• Email: fan_jiang[@]tongji.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC, Stage IIIA

Intervention

Drug:
• PD-1 and chemotherapy
Sintilimab+(Squamous)ABX+DDP/CBP, or (non-Squamous)PEM+DDP/CBP

Locations

Country	Name	City	State
China	Shanghai General Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Tongji University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologically complete response (pCR) rate		in three weeks after the surgical resection
Secondary	Major pathological response (MPR) rate		in three weeks after the surgical resection
Secondary	Disease-free survival (DFS)		one, two, three and five years since the initial treatment (each treatment is 2 days)
Secondary	Minimal residual disease(MRD)		in one week before each cycle and in the forth week after the surgical resection (each cycle is 21 days)