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A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
NCT07222566 · View on ClinicalTrials.gov ↗
Study Summary
This study is being done to find out if a new medicine called PF-08634404, when given with chemotherapy, works better than the present standard treatment (pembrolizumab with chemotherapy) for adults with a type of lung cancer called non-small cell lung cancer (NSCLC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body. To join the study, participants must meet the following conditions: * Be 18 years or older. * Have locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC. * Is not a candidate for complete surgical resection or curative chemoradiotherapy. * Do not have known actionable genomic alterations * Be treatment naïve for advanced or metastatic disease Participants in this study will be assigned to two different parts of the study depending on their type of tumor: participants with squamous NSCLC will be assigned to Part 1, while participants with non-squamous NSCLC will be assigned to Part 2. Each participant will be randomly assigned (like a flip of the coin) to one of two treatment groups in a blinded fashion: * Part 1 - Arm A or Part 2 - Arm C (Experimental Group): Will receive a new study medicine called PF-08634404 along with a kind of chemotherapy specific to the type of tumor. * Part 1 - Arm B or Part 2 - Arm D (Control Group): Will receive an approved medicine called pembrolizumab along with a kind of chemotherapy specific to the type of tumor. Participants will receive their assigned treatment through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, participants will receive PF-08634404 or Pembrolizumab in combination with chemotherapy followed by maintenance with either PF-08634404 or Pembrolizumab monotherapy (Part 1) or PF-08634404 or Pembrolizumab in combination with a chemotherapeutic drug (Part 2). Participants will continue receiving treatment if it is helping and not experiencing s
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL PF-08634404
- DRUG Chemotherapy Regimen 1
- DRUG Chemotherapy Regimen 2
Study Locations (17)
Other
- Icon Cancer Centre Hobart — Hobart
- National Hospital Organization Kyushu Cancer Center — Fukuoka
- Pan American Center for Oncology Trials, LLC- Dorado Office — Dorado
- BRCR Global Puerto Rico - Hato Rey — San Juan
Texas
- Texas Oncology - West Texas — El Paso
- Texas Oncology - Gulf Coast — Texas City
- Texas Oncology - Northeast Texas — Tyler
Florida
- Cancer Care Centers of Brevard, Inc. — Melbourne
- Mid Florida Hematology and Oncology Center — Orange City
Illinois
- Hope and Healing Cancer Services — New Lenox
- Illinois CancerCare, P.C. — Peoria
Tennessee
- Tennessee Cancer Specialists — Knoxville
- SCRI Oncology Partners — Nashville
Arkansas
- Highlands Oncology Group — Springdale
California
- Sansum Clinic — California City
New York
- Hematology Oncology Associates of Rockland — Nyack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,410 participants |
| Start Date | 2026-01-06 |
| Est. Completion | 2032-08-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07222566
The ClinicalTrials.gov registry entry for NCT07222566 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,410 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Lung Cancer appearing as the primary indexed condition, and to 4 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07222566 reports 17 study locations spanning 9 distinct geographic areas — top geographies include Other, Texas, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07222566 about?
NCT07222566 is a clinical study titled "A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer". This study is being done to find out if a new medicine called PF-08634404, when given with chemotherapy, works better than the present standard treatment (pembrolizumab with chemotherapy) for adults with a type of lung cancer called non-small cell lung cancer (NSCLC) that is either locally advanced ...
What is the current status of trial NCT07222566?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,410 participants. The study started on 2026-01-06. Estimated completion is 2032-08-26.
What conditions does trial NCT07222566 study?
This clinical trial studies the following conditions: Lung Cancer, Non-Small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung, Metastatic Non Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07222566?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), PF-08634404 (BIOLOGICAL), Chemotherapy Regimen 1 (DRUG), Chemotherapy Regimen 2 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07222566?
This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07222566 being conducted?
This trial has 17 study locations across Arkansas, California, Florida, Illinois, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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