A Study on the Efficacy of Atezolizumab Combined with Chemotherapy
ConditionLung Cancer, Small Cell
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Pulmonary Hospital, Shanghai, China
About this trial
This is a multicenter phase III simulated RCT study aimed to compare the efficacy and safety of atezolizumab combined with chemotherapy versus placebo combined with chemotherapy in small cell lung cancer.
Eligibility criteria
Qualifiers
Signed Informed Consent Form
Male or female, 18 years of age or older
ECOG performance status of 0 or 1
Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group (VALG) staging system
Disqualifiers
Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 1 week prior to randomization
Leptomeningeal disease
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) Patients with indwelling catheters (e.g., PleurX®) are allowed.
Trial design
Treatments tested in this trial
- Atezolizumab
- Etoposide
- Carboplatin
Treatment groups
1,430 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov