Recruiting

PF-08634404 and Chemotherapy for Advanced Non-Small Cell Lung Cancer

What is being tested

PF-08634404

+ Chemotherapy Regimen 1

+ Chemotherapy Regimen 2

BiologicalDrug

Who is being recruted

Bronchial Neoplasms+14

+ Carcinoma

+ Carcinoma, Bronchogenic

Over 18 Years

+25 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: January 2026

See protocol details

Summary

Principal SponsorPfizer

Study ContactPfizer CT.gov Call Center

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 6, 2026

Actual date on which the first participant was enrolled.

This study aims to determine if a new medication, PF-08634404, combined with chemotherapy, is more effective than the current standard treatment, pembrolizumab with chemotherapy, for adults with non-small cell lung cancer (NSCLC). This type of lung cancer is either locally advanced, meaning it has spread to nearby areas, or metastatic, meaning it has spread to other parts of the body. The study targets adults aged 18 or older who have not received previous treatment for advanced or metastatic NSCLC and do not have certain genetic changes in their tumors. The goal is to find a potentially better treatment option for those who cannot undergo surgery or certain other treatments. Participants will be divided into two groups based on their type of lung cancer: squamous or non-squamous NSCLC. They will be randomly assigned to receive either the new medicine PF-08634404 or the standard treatment pembrolizumab, both in combination with chemotherapy. These treatments are administered through an IV, meaning the medication is given directly into a vein. Treatment cycles will involve either continuing with the combination or switching to the new medicine or pembrolizumab alone, depending on the group. Regular check-ups will occur to monitor participants' health and how their cancer responds to treatment, initially every six weeks, then every twelve weeks after the first year. Participants will keep receiving treatment as long as it is beneficial and does not cause serious side effects.

Official TitleAN INTERVENTIONAL PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER

NCT07222566

Principal SponsorPfizer

Study ContactPfizer CT.gov Call Center

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

1410 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinomaCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasm MetastasisNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialNeoplastic ProcessesPathologic ProcessesRespiratory Tract DiseasesRespiratory Tract NeoplasmsPathological Conditions, Signs and SymptomsThoracic Neoplasms

Criteria

7 inclusion criteria required to participate

Expected survival ≥12 weeks

18 years of age or older at screening.

Measurable disease based on RECIST v1.1 per investigator.

Have pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV)squamous or non-squamous NSCLC and not be a candidate for complete surgical resection and curative concurrent/sequential chemoradiotherapy (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer Tumor, lymph nodes, metastasis (TNM) staging system).

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18 exclusion criteria prevent from participating

Participants with history of immunodeficiency

Previous systemic anti-tumor therapy including: Prior systemic therapy, including anti-PD-(L)1 therapy, for locally advanced, unresectable, or metastatic NSCLC, Previous treatment with immunotherapy, Prior radiotherapy > 30 Gy to the lung < 6 months of first dose of study intervention, Palliative local therapy < 2 weeks before the first dose of study intervention, Non-specific immunomodulatory therapy < 2 weeks before the first dose, Prior systemic anti-angiogenic therapy

Known to have a history of a severe allergy to any component of the study intervention, or a history of severe allergic reaction to chimeric or humanized antibody.

History of allogeneic organ / hematopoietic stem cell transplantation.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants will receive PF-08634404 combined with chemotherapy regimen 1, followed by maintenance therapy with PF-08634404.

Group II

Experimental

Participants will receive PF-08634404 combined with chemotherapy regimen 2, followed by maintenance therapy with PF-08634404 and chemotherapy.

Group III

Active Comparator

Participants will receive pembrolizumab combined with chemotherapy regimen 1, followed by maintenance therapy with pembrolizumab.

Group IV

Active Comparator

Participants will receive pembrolizumab combined with chemotherapy regimen 2, followed by maintenance therapy with pembrolizumab and chemotherapy.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 17 locations

Recruiting

Highlands Oncology Group

Springdale, United StatesOpen Highlands Oncology Group in Google Maps

Recruiting

Sansum Clinic

California City, United States

Recruiting

Cancer Care Centers of Brevard, Inc.

Melbourne, United States

Recruiting

Mid Florida Hematology and Oncology Center

Orange City, United States

Recruiting

17 Study Centers