Actively Recruiting
A Study on the Efficacy of Atezolizumab Combined with Chemotherapy
Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2025-01-17
1430
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study on the Efficacy of Atezolizumab Combined with Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed Informed Consent Form
- Male or female, 18 years of age or older
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed extensive-stage small cell lung cancer per VALG staging system
- No prior treatment for extensive-stage small cell lung cancer
- History of treated asymptomatic CNS metastases allowed if stable and meeting specific criteria
- Measurable disease by RECIST v1.1 criteria
- Adequate blood counts and organ function within 14 days prior to randomization
- Submission of pre-treatment tumor tissue sample during the study
- For women of childbearing potential, agreement to use contraception or abstain from heterosexual intercourse during treatment and for 90 days after last dose
You will not qualify if you...
- Active or untreated CNS metastases
- Spinal cord compression not definitively treated or unstable
- Leptomeningeal disease
- Uncontrolled pleural, pericardial effusion, or ascites requiring frequent drainage
- Uncontrolled or symptomatic hypercalcemia
- Other malignancies within 5 years except low risk treated cancers
- Pregnancy, lactation, or intention to become pregnant during study
- History of severe allergic reactions to chimeric or humanized antibodies
- Known allergy to atezolizumab components
- History of autoimmune diseases with exceptions for stable hypothyroidism, controlled Type I diabetes, and certain dermatologic conditions
- History of certain lung diseases or active pneumonitis
- Positive HIV test
- Active hepatitis B or C infections
- Active tuberculosis
- Severe infections at enrollment
- Significant cardiovascular disease or recent myocardial infarction
- Major surgery within 28 days prior to randomization
- Prior allogeneic bone marrow or solid organ transplant
- Other conditions that contraindicate investigational drug use or affect study results
- Previous anti-cancer therapy for extensive-stage small cell lung cancer
- Use of other investigational agents or clinical study participation within 28 days
- Live attenuated vaccine within 4 weeks before randomization or planned during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Shanghai, China, 200433
Actively Recruiting
Research Team
C
Chunxia Su, doctor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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