Study of PF-08634404 with Other Cancer Agents in Advanced Cancers

This study is investigating PF-08634404, a biological medicine given as an infusion, in combination with other anti-cancer agents like Sigvotatug Vedotin, for people with advanced non-small cell lung cancer (NSCLC). Researchers want to learn if these combinations are safe and what side effects might occur. For some parts of the study, your cancer's PD-L1 status must be at least 1%. The study will also measure how many participants respond to the treatment. You may be eligible if you are 18 or older and have advanced NSCLC that cannot be surgically removed or cured with standard treatments. The study aims to enroll 162 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 162 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for treatment-related events for up to approximately 5 years after their last study intervention.

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NCT07227298

Symbiotic-Lung-20: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers

Recruiting
PHASE1Ages 18+InterventionalTreatment
Pfizer
~162 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:PF-08634404Sigvotatug VedotinCombination Agent 1

At a glance

Recruiting sites
65 of 73 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured over Through 90 days after the last study intervention; Up to approximately 5 years
+2 more outcomes measured
Advanced/Metastatic Non-Small Cell Lung Cancer
Carcinoma, Non-Small Cell Lung
Non-Small Cell Lung Cancer
73 sites across 31 states
Virginia7
Spain7
California6
Florida6
New Jersey6
Taiwan6
Texas5
Arkansas3
  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

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Eligibility criteria

Inclusion

Pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC and are not a candidate for complete surgical resection and curative concurrent/sequential chemoradiotherapy
PD-L1 status available
Part B only: PD-L1 ≥ TPS 1%
Measurable disease based on RECIST v1.1 per investigator.
Eastern Cooperative Oncology Group performance status of 0 or 1.
Adequate organ function

Exclusion

Participants with known AGAs including EGFR, ALK and ROS1, NTRK, BRAF, and MET
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
Known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression
Leptomeningeal disease
Active autoimmune diseases requiring systemic treatment within the past 2 years
Previous systemic anti-tumor therapy for locally advanced, unresectable, or metastatic NSCLC
Previous treatment with immunotherapy (exception is (neo)adjuvant anti-PD-(L)1), ADCs containing MMAE payload, systemic anti-angiogenic therapy, or prior radiotherapy to the lung within 6 months of first dose of study intervention
  • Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)Through 90 days after the last study intervention; Up to approximately 5 years

    AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.

  • Phase I: Number of participants with dose limiting toxicity (DLT)Through 90 days after the last study intervention; Up to approximately 5 years

    Dose limiting toxicity based on dose limiting toxicity evaluable participants. The number of participants who experienced DLTs during the DLT observation period.

  • Phase 2: Confirmed Objective Response Rate (ORR) per RECIST v1.1 by investigatorUp to approximately 5 Years

    ORR is defined as the proportion of participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or confirmed Partial Response (PR) per RECIST v1.1.