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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

NCT ID: NCT07226999

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

550 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-17

Study Completion Date

2034-03-11

Brief Summary

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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.

Detailed Description

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Conditions

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Small Cell Lung Cancer (SCLC)

Keywords

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small cell lung cancer extensive stage small cell lung cancer first-line

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Phase 2 is open-label, whereas Phase 3 is double-blind, randomized design.

Study Groups

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Phase 2 Single arm

Participants will receive PF-08634404 in combination with chemotherapy

Group Type EXPERIMENTAL

PF-08634404

Intervention Type DRUG

Concentrate for solution for infusion

Chemotherapy

Intervention Type DRUG

Injection for intravenous use

Phase 3 Experimental Arm

Participants will receive PF-08634404 in combination with chemotherapy

Group Type EXPERIMENTAL

PF-08634404

Intervention Type DRUG

Concentrate for solution for infusion

Chemotherapy

Intervention Type DRUG

Injection for intravenous use

Phase3 Control Arm

Participants will receive atezolizumab in combination with chemotherapy

Group Type ACTIVE_COMPARATOR

Atezolizumab

Intervention Type BIOLOGICAL

Injection for intravenous use

Chemotherapy

Intervention Type DRUG

Injection for intravenous use

Interventions

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PF-08634404

Concentrate for solution for infusion

Intervention Type DRUG

Atezolizumab

Injection for intravenous use

Intervention Type BIOLOGICAL

Chemotherapy

Injection for intravenous use

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Central Contacts

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Pfizer CT.gov Call Center

Role: CONTACT

Phone: 1-800-718-1021

Email: [email protected]

Other Identifiers

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2025-523522-41-00

Identifier Type: CTIS

Identifier Source: secondary_id

C6461004

Identifier Type: -

Identifier Source: org_study_id