Combined Atezolizumab and Chemotherapy (Carboplatin Plus Etoposide) in Neoadjuvant Treating Limited-Stage Small Cell Lung Cancer Patients

Study Overview
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Brief Summary
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This Phase II study was designed to evaluate the safety and efficacy of Atezolizumab in combination with Chemotherapy compared with treatment with Chemotherapy alone in previously untreated Limited-Stage Small Cell Lung Cancer patients.

Detailed Description
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This Phase II study was designed to evaluate the safety and efficacy of Atezolizumab in combination with Chemotherapy (Carboplatin plus Etoposide) compared with treatment with Chemotherapy (Carboplatin plus Etoposide) alone in previously untreated Limited-Stage Small Cell Lung Cancer patients. Participants will be divided in a 1:1 ratio to receive either Atezolizumab + Carboplatin + Etoposide or Carboplatin + Etoposide followed by radical surgery.

Official Title
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Clinical Study of Programmed Cell Death Ligand-1(PD-L1) Antibody (Atezolizumab) Plus Chemotherapy (Carboplatin Plus Etoposide) for Previously Untreated Small Cell Lung Cancer

Conditions
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Small-cell Lung Cancer, Neoadjuvant Therapy

Intervention / Treatment
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* Drug: Atezolizumab
* Drug: Carboplatin
* Drug: Etoposide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be volunteered to participate in the clinical trial. Patients must sign the informed Consent form (ICF) and be willing to follow and able to complete all test procedures. Histologically or cytologically confirmed stage IIb-IIIb SCLC. Patients with good physical condition and good organ function. Previously untreated patients. Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Patients can tolerate chemotherapy, immunotherapy, and surgery. Exclusion Criteria: Unclear diagnosis of SCLC. Contraindicated chemotherapy, immunotherapy, and surgery. Undergoing other active malignancies within 5 years or at the same time.Patients with localized curable tumors, such as basal cell carcinoma, squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, or breast carcinoma in situ, will not be excluded. Positive test result for human immunodeficiency virus (HIV). Positive test result for active tuberculosis. Pregnant or lactating women A history of psychotropic substance abuse, drug abuse, or alcoholism. Other factors assessed by the sponsors.

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: Atezolizumab + Carboplatin +Etoposide +surgery<br>Neoadjuvant therapy: Atezolizumab, 1200 milligrams(mg) on Day 1 of every 21-day cycle, 2 cycles; Carboplatin, 75 mg per square meter(mg/m^2) on Day 1 of every 21-day cycle, 2 cycles; Etoposide, 100 mg/m^2 on Day 1 of every 3-day cycle, 2 cycles. Surgery: patients will receive surgery. | Drug: Atezolizumab<br>* Atezolizumab intravenous infusion was administered at a dose of 1200mg on Day 1 of each 21-day cycle.<br>Drug: Carboplatin<br>* Carboplatin intravenous infusion was administered at a dose of 75mg/m^2 on Day 1 of each 21-day cycle.<br>Drug: Etoposide<br>* Etoposide intravenous infusion was administered at a dose of 100 mg/m^2 on Day 1 of every 3-day cycle.<br>|
| Active Comparator: Carboplatin +Etoposide +surgery<br>Neoadjuvant therapy: Carboplatin, 75 mg/m^2 on Day 1 of every 21-day cycle, 2 cycles; Etoposide, 100 mg/m^2 on Day 1 of every 3-day cycle, 2 cycles. Surgery: patients will receive surgery. | Drug: Carboplatin<br>* Carboplatin intravenous infusion was administered at a dose of 75mg/m^2 on Day 1 of each 21-day cycle.<br>Drug: Etoposide<br>* Etoposide intravenous infusion was administered at a dose of 100 mg/m^2 on Day 1 of every 3-day cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival（DFS） | To assess disease free survival（DFS）after surgery. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate (DCR) | To assess disease control rate (DCR) after treatment. | 3 months | 
| Overall survival (OS) | To estimate overall survival (OS) of patients with ES-SCLC. | 24 months | 
| Objective response rate (ORR) | To evaluate objective response rate (ORR)after treatment. | 3 months | 
| Duration of response (DOR) | To evaluate duration of response (DOR) after treatment. | 3 months | 
| Major pathological response (MPR) | To evaluate major pathological response (MPR) after treatment. | 3 months | 
| Complete pathological response (CPR） | To evaluate complete pathological response (CPR）after treatment. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Limited-Stage Small Cell Lung Cancer, Atezolizumab, Immunotherapy, Carboplatin, Etoposide