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

Sponsor

Tongji University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05157776

Collaborator

(none)

Enrollment

Location

Arms

24.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
NSCLC, Stage IIIA EGF-R Negative Non-Small Cell Lung Cancer ALK Negative NSCLC	Drug: PD-1 and chemotherapy	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 28, 2021

Anticipated Primary Completion Date :

Oct 31, 2022

Anticipated Study Completion Date :

Oct 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Drug: PD-1 and chemotherapy Sintilimab+(Squamous)ABX+DDP/CBP, or (non-Squamous)PEM+DDP/CBP
Experimental: Experimental group Neoadjuvant therapy of Sintilimab and chemotherapy in 4 cycles before surgery	Drug: PD-1 and chemotherapy Sintilimab+(Squamous)ABX+DDP/CBP, or (non-Squamous)PEM+DDP/CBP

Arm

Intervention/Treatment

Active Comparator: 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

Drug: PD-1 and chemotherapy

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

Experimental: Experimental group

Neoadjuvant therapy of Sintilimab and chemotherapy in 4 cycles before surgery

Drug: PD-1 and chemotherapy

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

Outcome Measures

Primary Outcome Measures

Pathologically complete response (pCR) rate [in three weeks after the surgical resection]

Secondary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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;

Exclusion Criteria:

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.