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

Shanghai Pulmonary Hospital, Shanghai, China

Status and phase: Unknown; Phase 2

Conditions: Small-cell Lung Cancer; Neoadjuvant Therapy

Treatments: Drug: Carboplatin; Drug: Atezolizumab; Drug: Etoposide

Study type: Interventional

Funder types: Other

Identifiers

NCT04696939

2020LY032

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Histologically or cytologically confirmed stage IIb-IIIb SCLC.
3. Patients with good physical condition and good organ function.
4. Previously untreated patients.
5. Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
6. Patients can tolerate chemotherapy, immunotherapy, and surgery.

Exclusion criteria

1. Unclear diagnosis of SCLC.
2. Contraindicated chemotherapy, immunotherapy, and surgery.
3. 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.
4. Positive test result for human immunodeficiency virus (HIV).
5. Positive test result for active tuberculosis.
6. Pregnant or lactating women
7. A history of psychotropic substance abuse, drug abuse, or alcoholism.
8. Other factors assessed by the sponsors.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Atezolizumab + Carboplatin +Etoposide +surgery

Experimental group

Description:

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.

Treatment:

Drug: Atezolizumab

Drug: Carboplatin

Drug: Etoposide

Carboplatin +Etoposide +surgery

Active Comparator group

Description:

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.

Treatment:

Drug: Carboplatin

Drug: Etoposide