RecruitingInterventionalPhase 2/Phase 3

A GLOBAL PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER

NCT ID: NCT07226999Sponsor: PfizerLast updated: 2026-06-04

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.

Arms & interventions

DrugPF-08634404
Concentrate for solution for infusion
BiologicalAtezolizumab
Injection for intravenous use
DrugChemotherapy
Injection for intravenous use

Outcome measures

Primary

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
Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) is observed as best overall response. ORR using RECIST v1.1 as assessed by investigator.
Time frame: Up to approximately 2 years after completion of study treatment of last study participant
Phase 2: Number of participants with treatment-emergent adverse events
Adverse Events (AEs) as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
Time frame: Up to 90 days after the last dose of treatment
Phase 3: Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause. OS is secondary outcome measure in Phase 2 portion of the study.
Time frame: Up to approximately 2 years after completion of study treatment of last study participant

Secondary

Duration of Response (DOR) as assessed by Investigator based on RECIST v1.1
Time frame: Up to approximately 2 years after completion of study treatment of last study participant
Progression Free Survival (PFS) as assessed by investigator based on RECIST v1.1
Time frame: Up to approximately 2 years after completion of study treatment of last study participant
Number of participants with Laboratory abnormalities
Time frame: Up to 90 days after the last dose of treatment
Phase 2: Number of Participants who Experience a Dose-Limiting Toxicity (DLT)
Time frame: Up to 90 days after the last dose of treatment
Pharmacokinetics: Serum concentrations of PF-08634404
Time frame: Up to 37 days after the last dose of treatment
Incidence of antidrug antibody against PF-08634404
Time frame: Up to 37 days after the last dose of treatment
Phase 2: Overall Survival
Time frame: Up to approximately 2 years after completion of study treatment of last study participant
Phase 3: PFS using RECIST v1.1 as assessed by blinded independent central review (BICR)
Time frame: Up to approximately 2 years after completion of study treatment of last study participant
Phase 3: Confirmed ORR using RECIST v1.1 as assessed by BICR
Time frame: Up to approximately 2 years after completion of study treatment of last study participant
Phase 3: DOR using RECIST v1.1 as assessed by BICR
Time frame: Up to approximately 2 years after completion of study treatment of last study participant
Phase 3: Mean scores and Change from baseline in the global health status/quality of life (QoL), function, and symptom scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Time frame: Up to approximately 2 years after completion of study treatment of last study participant
Phase 3: Mean scores and Change from Baseline on the EORTC Quality of Life Cancer Questionnaire - Lung Cancer 13 (EORTC QLQ-LC13)
Time frame: Up to approximately 2 years after completion of study treatment of last study participant
Phase 3: Time to definitive deterioration (TTdD) in the global health status/QoL, function, and symptom scores on the EORTC QLQ-C30
Time frame: Up to approximately 2 years after completion of study treatment of last study participant
Phase 3: TTdD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13
Time frame: Up to approximately 2 years after completion of study treatment of last study participant

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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

Study locations (23)

Highlands Oncology Group

Fayetteville, Arkansas, 72703

Recruiting

Highlands Oncology Group

Rogers, Arkansas, 72758

Recruiting

Highlands Oncology Group

Springdale, Arkansas, 72762

Recruiting

BRCR Coral Springs

Coral Springs, Florida, 33065

Recruiting

Mid Florida Hematology and Oncology Center

Orange City, Florida, 32763

Recruiting

BRCR Global - Tamarac

Tamarac, Florida, 33321

Recruiting

Texas Oncology - Gulf Coast

Beaumont, Texas, 77702

Recruiting

Texas Oncology - San Antonio

Fredericksburg, Texas, 78624

Recruiting

Texas Oncology - Gulf Coast

Houston, Texas, 77024

Recruiting

Texas Oncology - Gulf Coast

Houston, Texas, 77054

Recruiting

Texas Oncology - San Antonio

New Braunfels, Texas, 78130

Recruiting

Texas Oncology - Gulf Coast

Pearland, Texas, 77584

Recruiting

Texas Oncology - San Antonio

San Antonio, Texas, 78217

Recruiting

Texas Oncology - San Antonio

San Antonio, Texas, 78240

Recruiting

Texas Oncology - San Antonio

San Antonio, Texas, 78258

Recruiting

Texas Oncology - Gulf Coast

Sugar Land, Texas, 77479

Recruiting

Texas Oncology - Gulf Coast

The Woodlands, Texas, 77380

Recruiting

Texas Oncology - Gulf Coast

Webster, Texas, 77598

Recruiting