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

Primary Purpose

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

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

PD-1 and chemotherapy

About this trial

This is an interventional treatment trial for NSCLC, Stage IIIA focused on measuring Neoadjuvant, PD-1, NSCLC, Phase III, Platinum-based, Locally Advanced

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Shanghai General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Experimental group

Arm Description

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

Neoadjuvant therapy of Sintilimab and chemotherapy in 4 cycles before surgery

Outcomes

Primary Outcome Measures

Pathologically complete response (pCR) rate

Secondary Outcome Measures

Major pathological response (MPR) rate

Disease-free survival (DFS)

Minimal residual disease(MRD)

Full Information

NCT ID

NCT05157776

First Posted

December 7, 2021

Last Updated

May 7, 2023

Sponsor

Tongji University

1. Study Identification

Unique Protocol Identification Number

NCT05157776

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 28, 2021 (Actual)

Primary Completion Date

October 31, 2024 (Anticipated)

Study Completion Date

October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tongji University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Neoadjuvant therapy of Sintilimab and chemotherapy in 4 cycles before surgery

Intervention Type

Drug

Intervention Name(s)

PD-1 and chemotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Pathologically complete response (pCR) rate

Time Frame

in three weeks after the surgical resection

Secondary Outcome Measure Information:

Title

Major pathological response (MPR) rate

Time Frame

in three weeks after the surgical resection

Title

Disease-free survival (DFS)

Time Frame

one, two, three and five years since the initial treatment (each treatment is 2 days)

Title

Minimal residual disease(MRD)

Time Frame

in one week before each cycle and in the forth week after the surgical resection (each cycle is 21 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jiang Fan, MD

Phone

15901013210

fan_jiang@tongji.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Dong Lin, MD

Phone

18121299433

dlin2014@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiang Fan, MD

Organizational Affiliation

Shanghai General Hospital; Shanghai Pulmonary Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai General Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200080

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jiang Fan, MD

Phone

02163240090

fan_jiang@tongji.edu.cn

First Name & Middle Initial & Last Name & Degree

Jiang Fan, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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