jRCT2031250576RecruitingNot Applicable
A GLOBAL PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER
Not provided0 sites550 target enrollmentStarted: TBD
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 550
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
Eligibility Criteria
- Ages
- 18age old over to No limit (—)
- Sex
- All
Inclusion Criteria
- •Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
- •Participants have not received systemic therapy (chemotherapy, radiotherapy, chemoradiation) for ES-SCLC.
- •Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
- •Have at least one measurable lesion as the targeted lesion based on RECIST V1.
- •Eastern Cooperative Oncology Group performance status of 0 or
- •Adequate organ function
Exclusion Criteria
- •known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression
- •Leptomeningeal disease
- •Clinically significant risk of hemorrhage or fistula
- •history of another malignancy within 3 years
- •active autoimmune diseases requiring systemic treatment within the past 2 years
Investigators
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