Effect and Safety of Envafolimab Combined With Endostar/S-1 in Second-line of Advanced Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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The trial was a randomized, open-label, multicenter Phase II study of patients with advanced or metastatic NSCLC who don't harbor driver genes. The aim is to explore the efficacy and safety of Envafolimab Combined With Endostar/S-1 in second-line treatment of advanced non-small cell lung cancer.

Detailed Description
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Patients with advanced (stage IV. NSCLC), after signing informed consent, are screened to meet the admission requirements. All the candidates are not randomly placed in 3 treatment groups (which treatment regimen the patient chooses is determined by the clinical supervisor on a patient-by-case basis).

Official Title
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An Exploratory Non-randomized Controlled Trial for Effect and Safety of Envafolimab Combined With Recombinant Human Endostartin Injection/S-1 in Second-line Treatment of Advanced Non-small Cell Lung Cancer

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: Envafolimab plus Endostar and S-1
* Drug: Envafolimab plus Endostar
* Drug: Envafolimab plus S-1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients are histologically or cytologically confirmed stage IV non-small cell lung cancer. Genetic testing identifies no driver gene mutations. Male or female, age > 18 years, < 75 years. Patients had not received PD-L1 inhibitors in first-line treatment. KPS score ≥ 70 points (ECOG score 0-1 points), the expected survival ≥3 months; No dysfunction of major organs. EcG, liver function, renal function, and blood count tests before treatment are normal or basically normal, but must meet the following experimental results: Blood routine test: Leukocyte WBC≥3.5×109/L; Neutrophil count (ANC) ≥ 1.5×109/L; Platelet (PLT) ≥ 80×109/L; Blood biochemical test: Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal values; Alanine aminotransferase (ALT/SGPT) and alanine transaminases (AST/SGOT) ≤ 2.5 times the normal high value (ULN), or ≤ 5 times the upper limit of normal value in patients with liver metastases; Serum creatinine (Cr) ≤ 1.5 times the upper limit of normal values; c. Cardiac function test: 50% of the left ventricular ejection function of the heart >; 6) The subject has good compliance, and can cooperates with follow-up. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Envafolimab plus Endostar and S-1<br>Envafolimab (300 mg subcutaneously each time, using 4-6 cycles), Recombinant Human Endostartin Injection (210 mg, d1-7 pumps, repeat every 3 weeks, using 4-6 cycles), Tegafur,Gimeracil and Oteracil Porassium Capsules (40 mg Bid, take 2 weeks stop for 1 week, use 4-6 cycles) | Drug: Envafolimab plus Endostar and S-1<br>* Immunotherapy combined with chemotherapy and anti VEGFR therapy<br>* Other names: Envafolimab combined with Recombinant Human Endostatin Injection/Tegafur,Gimeracil and Oteracil Porassium Capsules;|
| Active Comparator: Envafolimab plus Endostar<br>Envafolimab (300 mg subcutaneously each time, using 4-6 cycles), Recombinant Human Endostartin Injection (210 mg, d1-7 pumps, repeat every 3 weeks, using 4-6 cycles), | Drug: Envafolimab plus Endostar<br>* Immunotherapy combined with anti VEGFR therapy<br>* Other names: Envafolimab combined with Recombinant Human Endostatin Injection;|
| Active Comparator: Envafolimab plus S-1<br>Envafolimab (300 mg subcutaneously each time, using 4-6 cycles), Tegafur,Gimeracil and Oteracil Porassium Capsules (40 mg Bid, take 2 weeks stop for 1 week, use 4-6 cycles) | Drug: Envafolimab plus S-1<br>* Immunotherapy combined with chemotherapy<br>* Other names: Envafolimab combined with Tegafur,Gimeracil and Oteracil Porassium Capsules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate(ORR) | proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors | six weeks | 
| Adverse events | safety | three weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival(PFS) | the time from initial treatment to disease progression | six weeks | 
| overall survival(OS) | the time from initial treatment to death from any cause | six weeks |