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

NCT05157776 | Unknown Phase 3 DMC

• 1 other identifier: SGHDOT 21-10
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Neoadjuvant; PD-1; NSCLC; Phase III; Platinum-based; Locally Advanced

Outcome Measures

Primary Outcomes (1)

• Pathologically complete response (pCR) rate

  in three weeks after the surgical resection

Secondary Outcomes (3)

• 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)

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Drug: PD-1 and chemotherapy

Experimental group

EXPERIMENTAL

Neoadjuvant therapy of Sintilimab and chemotherapy in 4 cycles before surgery

Drug: PD-1 and chemotherapy

Interventions

PD-1 and chemotherapy DRUG

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

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Resectable stage IIIA NSCLC, EGFR mutation-negative and ALK rearrangement negative (8th UICC TNM staging);
• No prior anti-tumor therapy for NSCLC;
• Age from 18 to 75 years old;
• 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;
• 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;
• ECOG 0～1;

You may not qualify if:

• Double primary or multiple primary NSCLC;
• EGFR mutation or ALK mutation was positive
• patients with psychosis;
• Pre-existing or coexisting bleeding disorders;
• Other uncontrollable and inoperable patients;
• Patients whose previous operations have prevented this operation from being performed;
• Female patients who are pregnant or breastfeeding;
• For patients who are allergic to the drugs in the program.

Sponsors & Collaborators

• Tongji University: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40777124 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jiang Fan, MD

  Shanghai General Hospital; Shanghai Pulmonary Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiang Fan, MD

CONTACT

15901013210; fan_jiang@tongji.edu.cn

Dong Lin, MD

CONTACT

18121299433; dlin2014@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Thoracic Surgery

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 15, 2021
• Study Start: October 28, 2021
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2025
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)