Combined Atezolizumab and Chemotherapy (Carboplatin Plus Etoposide) in Neoadjuvant Treating Limited-Stage Small Cell Lung Cancer Patients
- Conditions
- Small-cell Lung CancerNeoadjuvant Therapy
- Interventions
- Registration Number
- NCT04696939
- Lead Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Carboplatin +Etoposide +surgery Carboplatin 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. Atezolizumab + Carboplatin +Etoposide +surgery Atezolizumab 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. Atezolizumab + Carboplatin +Etoposide +surgery Carboplatin 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. Atezolizumab + Carboplatin +Etoposide +surgery Etoposide 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. Carboplatin +Etoposide +surgery Etoposide 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.
- Primary Outcome Measures
Name Time Method Disease free survival（DFS） 12 months To assess disease free survival（DFS）after surgery.
- Secondary Outcome Measures
Name Time Method Objective response rate (ORR) 3 months To evaluate objective response rate (ORR)after treatment.
Overall survival (OS) 24 months To estimate overall survival (OS) of patients with ES-SCLC.
Disease control rate (DCR) 3 months To assess disease control rate (DCR) after treatment.
Complete pathological response (CPR） 3 months To evaluate complete pathological response (CPR）after treatment.
Major pathological response (MPR) 3 months To evaluate major pathological response (MPR) after treatment.
Duration of response (DOR) 3 months To evaluate duration of response (DOR) after treatment.
Trial Locations
- Locations (1)
Shanghai Pulmonary Hospital
🇨🇳Shanghai, Shanghai, China