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

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04696939

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Small-cell Lung Cancer Neoadjuvant Therapy	Drug: Atezolizumab Drug: Carboplatin Drug: Etoposide	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Atezolizumab + Carboplatin +Etoposide +surgery 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 Atezolizumab intravenous infusion was administered at a dose of 1200mg on Day 1 of each 21-day cycle. Drug: Carboplatin Carboplatin intravenous infusion was administered at a dose of 75mg/m^2 on Day 1 of each 21-day cycle. Drug: Etoposide Etoposide intravenous infusion was administered at a dose of 100 mg/m^2 on Day 1 of every 3-day cycle.
Active Comparator: Carboplatin +Etoposide +surgery 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 Carboplatin intravenous infusion was administered at a dose of 75mg/m^2 on Day 1 of each 21-day cycle. Drug: Etoposide Etoposide intravenous infusion was administered at a dose of 100 mg/m^2 on Day 1 of every 3-day cycle.

Arm

Intervention/Treatment

Experimental: Atezolizumab + Carboplatin +Etoposide +surgery

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

Atezolizumab intravenous infusion was administered at a dose of 1200mg on Day 1 of each 21-day cycle.

Drug: Carboplatin

Carboplatin intravenous infusion was administered at a dose of 75mg/m^2 on Day 1 of each 21-day cycle.

Drug: Etoposide

Etoposide intravenous infusion was administered at a dose of 100 mg/m^2 on Day 1 of every 3-day cycle.

Active Comparator: Carboplatin +Etoposide +surgery

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

Carboplatin intravenous infusion was administered at a dose of 75mg/m^2 on Day 1 of each 21-day cycle.

Drug: Etoposide

Etoposide intravenous infusion was administered at a dose of 100 mg/m^2 on Day 1 of every 3-day cycle.

Outcome Measures

Primary Outcome Measures

Disease free survival（DFS） [12 months]
To assess disease free survival（DFS）after surgery.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.