A Trial of SHR-1701 With or Without Chemotherapy in Patients With Stage III NSCLC
Phase 2
Active, not recruiting
- Conditions
- Non-Small-Cell Lung Cancer
- Interventions
- Drug: SHR-1701+Paclitaxel+carboplatin
- Registration Number
- NCT04580498
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 107
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group B SHR-1701 SHR-1701 Treatment group A SHR-1701+Paclitaxel+carboplatin SHR-1701+Paclitaxel+carboplatin
- Primary Outcome Measures
Name Time Method ORR From the initiation of the first dose to 3 years Objective response rate
EFS From the initiation of the first dose to 3 years event free survival
- Secondary Outcome Measures
Name Time Method OS From the initiation of the first dose to 3 years overall survival
EFS rate From the initiation of the first dose to 3 years event free survival rate
TDDM From the initiation of the first dose to 3 years time to death or distant metastasis
Adverse events(AEs) From the initiation of the first dose to 90 days after the last dose Incidence of treatment-related AEs
Trial Locations
- Locations (1)
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China