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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
EU CTIS ID: 2025-523461-17-01
What this study is testing
To demonstrate that PF-08634404 + chemotherapy (experimental arm) is superior to pembrolizumab + chemotherapy (control arm) in prolonging OS. To demonstrate that PF-08634404 + chemotherapy (experimental arm) is superior to pembrolizumab + chemotherapy (control arm) in prolonging PFS by BICR.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 18 years of age or older
- 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 chemoradiation per the AJCC Staging Manual and the UICC Staging System (Eighth edition).
- Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy
- PD-L1 status available based on local testing results
- Measurable disease based on RECIST v1.1 per investigator.
- ECOG PS score of 0 or 1
You likely can't join if
- Participants with known AGAs, including EGFR, ALK, ROS1, NTRK, BRAF, RET, and MET, for which there are approved first-line therapies per local SOC are ineligible. Documented negative results for EGFR, ALK, and ROS1 AGAs are required for participants with non-squamous histology.
- Major surgery < 4 weeks or minor surgery < 3 days prior to first dose of study intervention.
- History of severe bleeding tendency or coagulation dysfunction
- History of esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose.
- Participants with acute, chronic or symptomatic infections including participants positive for active HIV, HBV, or HCV.
- Participants with history of immunodeficiency
See the full eligibility criteria
Who can join
- 18 years of age or older
- 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 chemoradiation per the AJCC Staging Manual and the UICC Staging System (Eighth edition).
- Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy
- PD-L1 status available based on local testing results
- Measurable disease based on RECIST v1.1 per investigator.
- ECOG PS score of 0 or 1
- Expected survival ≥12 weeks
What rules you out
- Participants with known AGAs, including EGFR, ALK, ROS1, NTRK, BRAF, RET, and MET, for which there are approved first-line therapies per local SOC are ineligible. Documented negative results for EGFR, ALK, and ROS1 AGAs are required for participants with non-squamous histology.
- Major surgery < 4 weeks or minor surgery < 3 days prior to first dose of study intervention.
- History of severe bleeding tendency or coagulation dysfunction
- History of esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose.
- Participants with acute, chronic or symptomatic infections including participants positive for active HIV, HBV, or HCV.
- Participants with history of immunodeficiency
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior (in the past 5 years) or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.
- Previous systemic anti-tumor therapy including: -Prior systemic therapy, including anti-PD-(L)1 therapy, for locally advanced, unresectable, or metastatic NSCLC. a) (Neo)adjuvant anti-PD-(L)1 is allowed if recurrence or progression occurred ≥9 months after the last dose. b) Other (neo)adjuvant or definitive therapy is allowed if recurrence or progression occurred ≥6 months after the last dose. -Previous treatment with immunotherapy. -Prior radiotherapy to the lung < 6 months of first dose of study intervention. -Palliative local therapy < 2 weeks before the first dose. -Non-specific immunomodulatory therapy < 2 weeks before the first dose. -Prior systemic anti-angiogenic therapy.
- Prior immune-related AE that led to anti-PD-(L)1 treatment discontinuation, adverse events from prior immunotherapy not improved to Grade 1 before screening, or required treatment with systemic immunosuppressive therapy.
- Prior and concomitant therapy: -Therapeutic oral or parenteral anticoagulants or thrombolytic agents < 10 days to the first dose. -Chronic antiplatelet therapy <7 days to randomization. Live or attenuated live vaccine < 4 weeks to the first dose. -Current high-dose systemic corticosteroids. -Prohibited concomitant medication(s) < 21 days to the first dose.
- Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.
- Known active CNS lesions are excluded. Participants with definitively treated brain metastases (surgery and/or radiotherapy) may be eligible. Clinically inactive brain metastases of longest diameter < 1 cm are permitted.
- Participants with clinically significant risk of hemorrhage or fistula are excluded.
- Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
- Unresolved toxicities from prior anti-tumor therapy, that did not recover to NCI CTCAE v5.0 Grade 0 or 1.
- 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.
- Participants with any of the following respiratory conditions:-Evidence of noninfectious or drug-induced ILD or pneumonitis -Known DLCO (adjusted for hemoglobin) <50% predicted. -Grade ≥3 pulmonary disease unrelated to underlying malignancy.
- History of uncontrolled comorbidities within 6 months prior to the first dose including uncontrolled cardiac and cerebrovascular conditions, hypertension, diabetes and arterial/severe venous thromboembolic events.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- United States
- Japan
- Argentina
- United Kingdom
- China
- Israel
- Brazil
- Canada
- Australia
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; United States; Japan; Argentina; United Kingdom; China and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.