A Trial of SHR-1701 With or Without Chemotherapy in Patients With Stage III NSCLC

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Carboplatin; Paclitaxel

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;

• Other moderate to severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and seriously affect respiratory function;

• Severe cardiovascular and cerebrovascular diseases;

• Clinically significant bleeding symptoms or significant bleeding tendency within 1 month before the first dose;

• Arteriovenous thrombotic events within 3 months before the first dose;

• Positive HIV test;

• Active hepatitis B or C;

• Evidence of active tuberculosis infection within 1 year before the first dose;

• Serious infection within 4 years before the first dose;

• History of attenuated live vaccination 28 days before the first dose or expected to receive attenuated live vaccination during the study;

• Major surgeries other than diagnosis or biopsy within 28 days prior to first dose;

• Previous or planned allogeneic bone marrow transplantation or solid organ transplantation;

• History of severe allergic reactions to other monoclonal antibodies/fusion proteins;

• Allergic to any component of the randomized treatment regimen;

• Female subjects who are pregnant, lactating, or planning to get pregnant during the study period;

• Subjects who has a known history of psychotropic drug abuse, alcoholism, or drug abuse

• Presence of other conditions that, in the opinion of the investigator, would make participation in this clinical trial inappropriate.