An Open-label, Multicenter Phase II Clinical Trial of SHR-1701 With or Without Chemotherapy in the Treatment of Unresectable Stage III Non-small Cell Lung Cancer

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country107 target enrollmentNovember 10, 2020

ConditionsNon-Small-Cell Lung Cancer

InterventionsSHR-1701+Paclitaxel+carboplatin SHR-1701

DrugsSHR-1701+Paclitaxel+carboplatin SHR-1701

Overview

Phase: Phase 2
Intervention: SHR-1701+Paclitaxel+carboplatin
Conditions: Non-Small-Cell Lung Cancer
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 107
Locations: 1
Primary Endpoint: ORR
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is being conducted to evaluate the efficacy and safety of SHR-1701 with or without chemotherapy in the treatment of unresectable stage III non-small cell lung cancer

Registry

clinicaltrials.gov

Start Date

November 10, 2020

End Date

March 1, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntarily participate in the study and sign the informed consent form;
•18 to 70 years old, both male and female;
•ECOG score: 0-1
•histopathologically or cytologically confirmed, inoperable stage III squamous cell or non-squamous cell lung cancer;
•subjects who can provide fresh or archival tumor tissue;
•Measurable lesions available;
•Major organ function is basically normal;
•Non-surgically sterile female subjects of childbearing age must have a negative serum HCG test before randomization;

Exclusion Criteria

•histologically or cytologically confirmed mixed SCLC and NSCLC;
•subjects who have malignant pleural effusion;
•Previous systemic anti-tumor therapy for NSCLC;
•Previous thoracic radiotherapy;
•Subjects who participated in other clinical trials within 4 weeks or 5 drug half-lives(whichever is shorter) before the first dose.
•Systemic immunostimulant therapy before the first dose;
•Systemic immunosuppressive therapy before the first dose or were expected to require systemic immunosuppressive drugs during the study treatment;
•Subjects with autoimmune diseases;
•Other malignant tumors other than non-small cell lung cancer within 5 years before screening;
•Known or suspected interstitial pneumonia;

Arms & Interventions

Treatment group A

SHR-1701+Paclitaxel+carboplatin

Intervention: SHR-1701+Paclitaxel+carboplatin

Treatment group B

SHR-1701

Intervention: SHR-1701

Outcomes

Primary Outcomes

ORR

Time Frame: From the initiation of the first dose to 3 years

Objective response rate

EFS

Time Frame: From the initiation of the first dose to 3 years

event free survival

Secondary Outcomes

OS(From the initiation of the first dose to 3 years)
EFS rate(From the initiation of the first dose to 3 years)
TDDM(From the initiation of the first dose to 3 years)
Adverse events(AEs)(From the initiation of the first dose to 90 days after the last dose)