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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Atezolizumab intravenous infusion was administered at a dose of 1200mg on Day 1 of each 21-day cycle.
Carboplatin intravenous infusion was administered at a dose of 75mg/m\^2 on Day 1 of each 21-day cycle.
Etoposide intravenous infusion was administered at a dose of 100 mg/m\^2 on Day 1 of every 3-day cycle.
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Disease free survival(DFS)
To assess disease free survival(DFS)after surgery.
Time frame: 12 months
Disease control rate (DCR)
To assess disease control rate (DCR) after treatment.
Time frame: 3 months
Overall survival (OS)
To estimate overall survival (OS) of patients with ES-SCLC.
Time frame: 24 months
Objective response rate (ORR)
To evaluate objective response rate (ORR)after treatment.
Time frame: 3 months
Duration of response (DOR)
To evaluate duration of response (DOR) after treatment.
Time frame: 3 months
Major pathological response (MPR)
To evaluate major pathological response (MPR) after treatment.
Time frame: 3 months
Complete pathological response (CPR)
To evaluate complete pathological response (CPR)after treatment.
Time frame: 3 months
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