Neoadjuvant Therapy, Small-cell Lung Cancer
Conditions
Keywords
Limited-Stage Small Cell Lung Cancer, Atezolizumab, Immunotherapy, Carboplatin, Etoposide
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.
Interventions
DRUGAtezolizumab
Atezolizumab intravenous infusion was administered at a dose of 1200mg on Day 1 of each 21-day cycle.
DRUGCarboplatin
Carboplatin intravenous infusion was administered at a dose of 75mg/m\^2 on Day 1 of each 21-day cycle.
DRUGEtoposide
Etoposide intravenous infusion was administered at a dose of 100 mg/m\^2 on Day 1 of every 3-day cycle.
Sponsors
Shanghai Pulmonary Hospital, Shanghai, China
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival（DFS） | 12 months | To assess disease free survival（DFS）after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Disease control rate (DCR) | 3 months | To assess disease control rate (DCR) 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. |
| Duration of response (DOR) | 3 months | To evaluate duration of response (DOR) after treatment. |
Countries
China
Contacts
Primary ContactYayi He, Doctor
Outcome results
None listed