What is PF-08634404 studying for extensive-stage small cell lung cancer?

PF-08634404 is being studied in combination with chemotherapy to understand its effects in adults with extensive-stage small cell lung cancer. The trial compares this combination to another approved treatment, aiming to evaluate which approach works better. Pfizer sponsors this global phase 2/3 clinical trial.

Who may be eligible for this extensive-stage small cell lung cancer clinical trial?

Adults 18 years or older with confirmed extensive-stage small cell lung cancer who have not previously received chemotherapy or radiation for this condition may be eligible. Participants must have good physical health and adequate organ function. Please review eligibility criteria for more details.

Is there any cost to participate in this extensive-stage small cell lung cancer clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses to and from study visits may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Phase 3

Age: 18Years +

All Genders

ID07226999

A Global Phase 2/3 Interventional Study of PF-08634404 Combined with Chemotherapy in Adults with Extensive-Stage Small Cell Lung Cancer

Led by Pfizer · Updated on 2026-06-04

550

Participants Needed

Research Sites

195 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying a new medicine called PF-08634404 in combination with chemotherapy for adults with extensive-stage small cell lung cancer (ES-SCLC), a fast-growing lung cancer that has spread widely in the body. The study aims to learn how well PF-08634404 works and how safe it is when given with chemotherapy compared to another approved treatment, atezolizumab plus chemotherapy. The study is a global phase 2/3 randomized trial sponsored by Pfizer. Participants will receive treatments through intravenous (IV) infusions during repeated cycles. The study has two parts: the first part focuses on checking safety and tolerance of PF-08634404 plus chemotherapy, while the second part compares PF-08634404 plus chemotherapy to atezolizumab plus chemotherapy to evaluate which works better. Some participants may continue receiving PF-08634404 alone after the initial treatment period. During the study, participants will have regular assessments including scans to measure tumor response, laboratory tests to monitor organ function, and evaluations of side effects. Researchers will track outcomes like overall survival, tumor response rate, progression-free survival, and quality of life using specific questionnaires. Safety monitoring will continue for up to 90 days after treatment. Participation may last for about two years after the last treatment dose for follow-up and outcome measurement.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC)
No prior systemic therapy (chemotherapy, radiotherapy, or chemoradiation) for ES-SCLC
Treatment-free for at least 6 months since last chemo/radiotherapy if previously treated for limited-stage SCLC
At least one measurable lesion based on RECIST V1.1
Eastern Cooperative Oncology Group performance status of 0 or 1
Adequate organ function based on medical tests

You will not qualify if you...

Known active central nervous system lesions, including brainstem, meningeal, or spinal cord metastases or compression
Leptomeningeal disease
Clinically significant risk of bleeding or fistula
History of another malignancy within the past 3 years
Active autoimmune diseases requiring systemic treatment within the past 2 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to approximately 2 years or until disease progression or discontinuation

Participants receive PF-08634404 in combination with chemotherapy or atezolizumab in combination with chemotherapy as part of the study treatment.

Multiple visits for treatment and monitoring during therapy

Follow-up

Duration - Up to 90 days after the last dose of treatment and up to approximately 2 years for survival follow-up

Participants are monitored for safety and survival after completing the study treatment.

Visits as scheduled for safety assessments and survival monitoring

Trial Site Locations

Total: 43 locations

Highlands Oncology Group

Fayetteville, Arkansas, United States, 72703

Actively Recruiting

Highlands Oncology Group

Rogers, Arkansas, United States, 72758

Actively Recruiting

Highlands Oncology Group

Springdale, Arkansas, United States, 72762

Actively Recruiting

BRCR Coral Springs

Coral Springs, Florida, United States, 33065

Actively Recruiting

Mid Florida Hematology and Oncology Center

Orange City, Florida, United States, 32763

Actively Recruiting

BRCR Global - Tamarac

Tamarac, Florida, United States, 33321

Actively Recruiting

Texas Oncology - Gulf Coast

Beaumont, Texas, United States, 77702

Actively Recruiting

Texas Oncology - San Antonio

Fredericksburg, Texas, United States, 78624

Actively Recruiting

Texas Oncology - Gulf Coast

Houston, Texas, United States, 77024

Actively Recruiting

Texas Oncology - Gulf Coast

Houston, Texas, United States, 77054

Actively Recruiting

Texas Oncology - San Antonio

New Braunfels, Texas, United States, 78130

Actively Recruiting

Texas Oncology - Gulf Coast

Pearland, Texas, United States, 77584

Actively Recruiting

Texas Oncology - San Antonio

San Antonio, Texas, United States, 78217

Actively Recruiting

Texas Oncology - San Antonio

San Antonio, Texas, United States, 78240

Actively Recruiting

Texas Oncology - San Antonio

San Antonio, Texas, United States, 78258

Actively Recruiting

Texas Oncology - Gulf Coast

Sugar Land, Texas, United States, 77479

Actively Recruiting

Texas Oncology - Gulf Coast

The Woodlands, Texas, United States, 77380

Actively Recruiting

Texas Oncology - Gulf Coast

Webster, Texas, United States, 77598

Actively Recruiting