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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Non-Small-Cell Lung Cancer

Intervention / Treatment
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* Drug: SHR-1701+Paclitaxel+carboplatin
* Drug: SHR-1701


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A<br>SHR-1701+Paclitaxel+carboplatin | Drug: SHR-1701+Paclitaxel+carboplatin<br>* Drug: SHR-1701 30mg/kg Drug: Paclitaxel 175mg/m2 Drug: Carboplatin AUC 5<br>|
| Experimental: Treatment group B<br>SHR-1701 | Drug: SHR-1701<br>* Drug: SHR-1701 30mg/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective response rate | From the initiation of the first dose to 3 years | 
| EFS | event free survival | From the initiation of the first dose to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | overall survival | From the initiation of the first dose to 3 years | 
| EFS rate | event free survival rate | From the initiation of the first dose to 3 years | 
| TDDM | time to death or distant metastasis | From the initiation of the first dose to 3 years | 
| Adverse events(AEs) | Incidence of treatment-related AEs | From the initiation of the first dose to 90 days after the last dose |