Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT07226999

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

Led by Pfizer · Updated on 2026-04-20

550

Participants Needed

32

Research Sites

430 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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

Eligible

You may qualify if you...

  • 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
Not Eligible

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 hemorrhage or fistula
  • History of another malignancy within 3 years
  • Active autoimmune diseases requiring systemic treatment within the past 2 years

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 32 locations

1

Highlands Oncology Group

Fayetteville, Arkansas, United States, 72703

Actively Recruiting

2

Highlands Oncology Group

Rogers, Arkansas, United States, 72758

Actively Recruiting

3

Highlands Oncology Group

Springdale, Arkansas, United States, 72762

Actively Recruiting

4

BRCR Coral Springs

Coral Springs, Florida, United States, 33065

Actively Recruiting

5

BRCR Global - Coral Springs

Coral Springs, Florida, United States, 33065

Actively Recruiting

6

Mid Florida Hematology and Oncology Center

Orange City, Florida, United States, 32763

Actively Recruiting

7

BRCR Global - Tamarac

Tamarac, Florida, United States, 33321

Actively Recruiting

8

Clario

Philadelphia, Pennsylvania, United States, 19103

Not Yet Recruiting

9

Texas Oncology - Gulf Coast

Beaumont, Texas, United States, 77702

Actively Recruiting

10

Texas Oncology - San Antonio

Fredericksburg, Texas, United States, 78624

Actively Recruiting

11

Texas Oncology - Gulf Coast

Houston, Texas, United States, 77024

Actively Recruiting

12

Texas Oncology - Gulf Coast

Houston, Texas, United States, 77054

Actively Recruiting

13

Texas Oncology - San Antonio

New Braunfels, Texas, United States, 78130

Actively Recruiting

14

Texas Oncology - Gulf Coast

Pearland, Texas, United States, 77584

Actively Recruiting

15

Texas Oncology - San Antonio

San Antonio, Texas, United States, 78217

Actively Recruiting

16

Texas Oncology - San Antonio

San Antonio, Texas, United States, 78240

Actively Recruiting

17

Texas Oncology - San Antonio

San Antonio, Texas, United States, 78258

Actively Recruiting

18

Texas Oncology - Gulf Coast

Sugar Land, Texas, United States, 77479

Actively Recruiting

19

Texas Oncology - Gulf Coast

The Woodlands, Texas, United States, 77380

Actively Recruiting

20

Texas Oncology - Gulf Coast

Webster, Texas, United States, 77598

Actively Recruiting

21

Border Medical Oncology Research Unit

Albury, New South Wales, Australia, 2640

Not Yet Recruiting

22

Hôpital Ambroise Paré

Boulogne-Billancourt, Île-de-France Region, France, 92100

Not Yet Recruiting

23

Kansai Medical University Hospital

Hirakata, Osaka, Japan, 573-1191

Actively Recruiting

24

Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka, Japan, 411-8777

Actively Recruiting

25

Doctor's Center Hematology & Oncology Group

Manati, Puerto Rico, 00674

Actively Recruiting

26

Pan American Center for Oncology Trials, LLC - Mayaguez Office Mayaguez Medical Center

Mayagüez, Puerto Rico, 00680

Actively Recruiting

27

Pan American Center for Oncology Trials, LLC

San Juan, Puerto Rico, 00909

Actively Recruiting

28

Hospital Oncologico Dr. Isaac Gonzalez-Martinez

San Juan, Puerto Rico, 00935

Actively Recruiting

29

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de, Spain, 28041

Not Yet Recruiting

30

National Cheng Kung University Hospital

Tainan, Taiwan, 704302

Not Yet Recruiting

31

National Taiwan University Hospital

Taipei, Taiwan, 10002

Not Yet Recruiting

32

Taipei Medical University Hospital

Taipei, Taiwan, 110

Actively Recruiting

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Research Team

P

Pfizer CT.gov Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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