Status:
UNKNOWN
Combined Atezolizumab and Chemotherapy (Carboplatin Plus Etoposide) in Neoadjuvant Treating Limited-Stage Small Cell Lung Cancer Patients
Lead Sponsor:
Shanghai Pulmonary Hospital, Shanghai, China
Conditions:
Small-cell Lung Cancer
Neoadjuvant Therapy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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-St...
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 (Carboplati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04696939
Start Date
January 1 2021
End Date
October 1 2023
Last Update
January 6 2021
Active Locations (1)
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1
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433