OncoMatch/Clinical Trials/NCT07222566
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
Is NCT07222566 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including PF-08634404 and Pembrolizumab for advanced non-small cell lung cancer.
Treatment: PF-08634404 · Pembrolizumab · Chemotherapy Regimen 1 · Chemotherapy Regimen 2 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Small Cell Lung Cancer
Biomarker criteria
Required: PD-L1 (CD274) status available (testing required; no eligibility threshold specified)
PD-L1 status available based on local testing results
Excluded: EGFR actionable genomic alteration
Participants with known actionable genomic alteration (AGAs), including estimated glomerular filtration rate (EGFR)...are ineligible. Documented negative results for EGFR...AGAs are required for participants with non-squamous histology.
Excluded: ALK actionable genomic alteration
Participants with known actionable genomic alteration (AGAs), including...anaplastic lymphoma kinase (ALK)...are ineligible. Documented negative results for ALK...AGAs are required for participants with non-squamous histology.
Excluded: ROS1 actionable genomic alteration
Participants with known actionable genomic alteration (AGAs), including...Repressor of Silencing 1 (ROS1)...are ineligible. Documented negative results for ROS1...AGAs are required for participants with non-squamous histology.
Excluded: NTRK1 actionable genomic alteration
Participants with known actionable genomic alteration (AGAs), including...neurotrophic tyrosine receptor kinase (NTRK)...are ineligible.
Excluded: NTRK2 actionable genomic alteration
Participants with known actionable genomic alteration (AGAs), including...neurotrophic tyrosine receptor kinase (NTRK)...are ineligible.
Excluded: NTRK3 actionable genomic alteration
Participants with known actionable genomic alteration (AGAs), including...neurotrophic tyrosine receptor kinase (NTRK)...are ineligible.
Excluded: BRAF actionable genomic alteration
Participants with known actionable genomic alteration (AGAs), including...v-raf murine sarcoma viral oncogene homolog B1 (BRAF)...are ineligible.
Excluded: RET actionable genomic alteration
Participants with known actionable genomic alteration (AGAs), including...rearranged during transfection (RET)...are ineligible.
Excluded: MET actionable genomic alteration
Participants with known actionable genomic alteration (AGAs), including...mesenchymal-epithelial transition (MET)...are ineligible.
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anti-tumor therapy
Previous systemic anti-tumor therapy including: Prior systemic therapy, including anti-PD-(L)1 therapy, for locally advanced, unresectable, or metastatic NSCLC.
Cannot have received: immunotherapy
Previous treatment with immunotherapy
Cannot have received: radiotherapy
Exception: Prior radiotherapy > 30 Gy to the lung < 6 months of first dose of study intervention
Prior radiotherapy > 30 Gy to the lung < 6 months of first dose of study intervention
Cannot have received: palliative local therapy
Exception: Palliative local therapy < 2 weeks before the first dose of study intervention
Palliative local therapy < 2 weeks before the first dose of study intervention
Cannot have received: non-specific immunomodulatory therapy
Exception: Non-specific immunomodulatory therapy < 2 weeks before the first dose
Non-specific immunomodulatory therapy < 2 weeks before the first dose
Cannot have received: systemic anti-angiogenic therapy
Prior systemic anti-angiogenic therapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Highlands Oncology Group · Springdale, Arkansas
- Sansum Clinic · California City, California
- Cancer Care Centers of Brevard, Inc. · Melbourne, Florida
- Mid Florida Hematology and Oncology Center · Orange City, Florida
- Hope and Healing Cancer Services · New Lenox, Illinois
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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