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

Conditions

• Small Cell Lung Cancer (SCLC)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PF-08634404 — DRUG
  Concentrate for solution for infusion
• Atezolizumab — BIOLOGICAL
  Injection for intravenous use
• Chemotherapy — DRUG
  Injection for intravenous use

Study Details

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.

Key Dates

Start date

Dec 9, 2025

Status verified

Jun 2026

Primary completion

Jun 14, 2030

Completion

Mar 11, 2034

Study Design

Enrollment

550 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 2 Single arm
  Participants will receive PF-08634404 in combination with chemotherapy
• Experimental: Phase 3 Experimental Arm
  Participants will receive PF-08634404 in combination with chemotherapy
• Active Comparator: Phase3 Control Arm
  Participants will receive atezolizumab in combination with chemotherapy

Primary Outcome Measure

Phase 2: Confirmed Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] based on the investigator's assessment [ Time Frame: Up to approximately 2 years after completion of study treatment of last study participant ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (23)

Find similar trials in Fayetteville, AR

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