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PF-08634404 / Advanced Non Small Cell Lung Cancer / Carcinoma, Non Small Cell Lung · Phase 3 Trial
ClinicalTrials.gov · August 17, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 randomized controlled trial registration (NCT07222566) comparing PF-08634404 plus chemotherapy to pembrolizumab plus chemotherapy in treatment-naïve adults with locally advanced or metastatic non-squamous and squamous NSCLC. No results have been posted in this registry record; the study is currently recruiting and outcome data are not yet available.
Phase 3, Interventional, Randomized, Parallel, Double masking, Treatment purpose. Advanced Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung, Carcinoma, Non-Small-Cell Lung (NSCLC), Metastatic Non Small C…; age from 18 Years. Intervention: Arm A; Arm C. Compared with: Arm B — Active Comparator; Arm D — Active Comparator. n = 1,410. 440 sites across 20 countries.
This is a Phase 3 randomized controlled trial registration (NCT07222566) comparing PF-08634404 plus chemotherapy to pembrolizumab plus chemotherapy in treatment-naïve adults with locally advanced or metastatic non-squamous and squamous NSCLC. No results have been posted in this registry record; the study is currently recruiting and outcome data are not yet available.
This is a registry record with no outcome data posted; no efficacy or safety results are available
This trial is designed to determine whether PF-08634404 improves overall survival or progression-free survival compared to the standard-of-care pembrolizumab plus chemotherapy in advanced NSCLC. Results, when available, may inform treatment selection for this patient population.
This is a Phase 3 trial registration with no results posted; the study is actively recruiting and outcomes have not yet been assessed or reported.
As stated by the source record.
Quoted from the source exactly as published.
This trial is designed to determine whether PF-08634404 improves overall survival or progression-free survival compared to the standard-of-care pembrolizumab plus chemotherapy in advanced NSCLC. Results, when available, may inform treatment selection for this patient population.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07222566). This is a study registration, not published results. Lead sponsor: Pfizer. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 1410 participants (ESTIMATED). Conditions: Advanced Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung, Carcinoma, Non-Small-Cell Lung (NSCLC), Metastatic Non Small Cell Lung Cancer, Lung Cancer. Interventions: BIOLOGICAL: PF-08634404; BIOLOGICAL: Pembrolizumab; DRUG: Chemotherapy Regimen 1; DRUG: Chemotherapy Regimen 2. Primary outcome measures: Overall Survival , Approximately 39 months; Progression Free Survival (PFS) assessed by blinded independent central review (BICR) , Approximately 32 months. Brief 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 serious side effects. The study will include regular visits for: * Treatment and health checks: while participant continues receiving treatment. * Tests to monitor how cancer responds: every 6 weeks during the first 48 weeks, then every 12 weeks thereafter.
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