Symbiotic-Lung-04: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Extensive-Stage Small Cell Lung Cancer

Summary

This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to adults with extensive-stage small cell lung cancer (ES-SCLC), a fast-growing type of lung cancer that has spread widely in the body. To join the study, participants must meet the following conditions: * Be 18 years or older. * Have extensive-stage small cell lung cancer confirmed by lab tests. * Have not received chemotherapy or radiation for this type of lung cancer. * Be in good physical condition and have healthy organs based on medical tests. The study has two parts: * In the first part, researchers will check how safe the study medicine is and how well people tolerate it when given with chemotherapy. * In the second part, they will compare study medicine plus chemotherapy to another approved treatment (atezolizumab plus chemotherapy) to see which works better. Participants will receive the treatment through IV infusions (medicine given directly into a vein). The treatment will be given in repeated time periods called cycles. Some participants will continue receiving the study medicine alone after the initial treatment.

Eligibility

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 V1.1.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* 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

Conditions3

Interventions2

Locations20 sites

Find trials near these locations

Related trials

• A Modular Multi-Basket Trial to Improve Personalized Medicine in Cancer Patients (Basket of Baskets) — Vall d'Hebron Institute of Oncology
• A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Treatment-refractory Solid Tumor Patients (South Korea) — Bionoxx Inc.
• A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study — Hoffmann-La Roche
• A Study on the Efficacy of Atezolizumab Combined with Chemotherapy — Shanghai Pulmonary Hospital, Shanghai, China
• A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice — Hoffmann-La Roche
• Atezolizumab Combined With Platinum-based Chemotherapy as Neoadjuvant Therapy for Patients With Resectable Stage II-IIIB — Hunan Province Tumor Hospital
• Atezolizumab and Bevacizumab With Photon Radiotherapy for Unresectable Hepatocellular Carcinoma — Chang Gung Memorial Hospital
• Atezolizumab and Rechallenge Chemotherapy in Relapsed Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC). — Gruppo Oncologico Italiano di Ricerca Clinica

Browse More Trials