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NCT07222566 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Non-Small Cell Lung Cancer and Lung Cancer, sponsored by Pfizer.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,410
- Enrollment target
- 17
- Study locations
NCT07222566: Recruiting Phase 3 study of Non-Small Cell Lung Cancer and Lung Cancer, sponsored by Pfizer.
NCT07222566 is a Phase 3 study of Non-Small Cell Lung Cancer and Lung Cancer that is actively recruiting participants, run by Pfizer. The registered enrollment target is 1,410 participants, above the 649-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (117% higher). The trial reports 17 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07222566, a Phase 3 study of Non-Small Cell Lung Cancer and Lung Cancer, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,410 participants
- Enrollment target
- 17
- Study locations
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
Primary Outcome
Overall survival defined as the time from the date of randomization to the date of death due to any cause.
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 |
What NCT07222566 shows while recruiting
NCT07222566 is an interventional study that assigns participants to a tested intervention. Its 1,410 participants enrollment target places it among the larger protocols in the corpus, above the 649-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (117% higher).
The record links to 6 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT07222566 lists 17 locations in 9 states (Other, Texas, Florida).
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: Non-Small Cell Lung Cancer, Lung Cancer, Carcinoma, Non-Small Cell Lung, Metastatic Non Small Cell Lung Cancer, Advanced Non-Small-Cell Lung Cancer.
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).
Who is sponsoring clinical trial NCT07222566?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT07222566's enrollment target sits among peer trials
1,410 13th of 454 higher than 441 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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