PF-08634404 combined with other cancer medicines for advanced non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1/2 program tests PF-08634404 in several combination arms alongside different anticancer agents, including an antibody‑drug conjugate (sigvotatug vedotin). Early dose-escalation cohorts will determine safe dose levels and side effects, and expansion cohorts will look for signs of tumor shrinkage and clinical benefit using RECIST v1.1. Eligible participants are adults with measurable, locally advanced or metastatic NSCLC, good performance status (ECOG 0–1), and adequate organ function; one expansion arm requires PD-L1 TPS ≥1%. The main goals are to define tolerability, characterize adverse events, and see if the combinations produce objective responses.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* Participants with known AGAs including EGFR, ALK and ROS1, NTRK, BRAF, and MET for which there are available first-line therapies per local standard-of-care (SOC)
* History of another malignancy within 2 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 or metastatic NSCLC
* Previous treatment with immunotherapy (exception is (neo)adjuvant or consolidation anti-PD-(L)1), ADCs containing MMAE payload, systemic anti-angiogenic therapy, or prior radiotherapy \>30 Gy to the lung within 6 months of first dose of study intervention

Where it's running

• Highlands Oncology Group, PA
  Fayetteville, Arkansas, United States Recruiting
• Highlands Oncology Group, PA
  Rogers, Arkansas, United States Recruiting
• Highlands Oncology Group, PA
  Springdale, Arkansas, United States Recruiting
• Providence Medical Foundation
  Fullerton, California, United States Recruiting
• Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center and Infusion Center
  Fullerton, California, United States Recruiting
• Providence St. Jude Medical Center
  Fullerton, California, United States Recruiting

+54 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.