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

AN INTERVENTIONAL OPEN-LABEL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF PF-08634404 IN COMBINATION WITH DIFFERENT ANTICANCER AGENTS IN PARTICIPANTS WITH ADVANCED SOLID TUMORS

PHASE1; PHASE2 · Pfizer · NCT07227298

This will test whether PF-08634404 given with other cancer medicines is safe and can help adults with advanced or metastatic non-small cell lung cancer.

Quick facts

PhasePHASE1; PHASE2
Study typeInterventional
Enrollment162 (estimated)
Ages18 Years and up
SexAll
SponsorPfizer (industry)
Drugs / interventionsimmunotherapy
Locations32 sites (Fayetteville, Arkansas and 31 other locations)
Trial IDNCT07227298 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with pathologically confirmed locally advanced or metastatic NSCLC, measurable disease, ECOG 0–1, adequate organ function, and (for Part B) PD-L1 TPS ≥1% are the intended participants.

Not a fit: Patients with known targetable genomic alterations (EGFR, ALK, ROS1, NTRK, BRAF, MET), active central nervous system metastases or leptomeningeal disease, recent other malignancies, active autoimmune disease requiring systemic treatment, or prior systemic therapy for their advanced disease may be excluded or unlikely to benefit.

Why it matters

Potential benefit: If successful, these combinations could offer an additional treatment option that controls tumors for some people with advanced NSCLC.

How similar studies have performed: Combining novel targeted agents or antibody‑drug conjugates with other anticancer drugs has shown promise in other NSCLC programs, but PF-08634404 combinations are early-stage and not yet proven.

Eligibility criteria

Show full inclusion / exclusion criteria 
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
* 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

Where this trial is running

Fayetteville, Arkansas and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Advanced/Metastatic Non-Small Cell Lung Cancer, Carcinoma, Non-Small Cell Lung, Non-Small Cell Lung Cancer, non-small cell lung cancer, NSCLC, advanced solid tumors, metastatic non-small cell lung cancer, locally advanced non-small cell lung cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.