Symbiotic-Lung-20: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers
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
3 other identifiers
interventional
162
4 countries
32
Brief Summary
This study is being done to learn more about a new medicine called PF-08634404 and how it works when used with other cancer medicines in people who have advanced solid tumors. An advanced solid tumor is a type of cancer that has spread beyond its original location and cannot be removed by surgery or cured with standard treatments. To join in the study, participants must:
- Be 18 years or older
- Participants with advanced non-small cell lung cancer (NSCLC), a type of lung cancer that has spread The study will look at:
- Whether PF-08634404 is safe to use with other cancer medicines.
- What side effects may happen. A side effect is anything the medicine does to your body that is not part of treating your disease.
- Whether the combination of PF-08634404 and other cancer medicines can help treat solid tumors. The study has different parts, each testing PF-08634404 with a different cancer medicine:
- Part A will test PF-08634404 with a medicine called sigvotatug vedotin.
- Part B of the study will look at how well the new medicine PF-08634404 works when used together with another medicine. Participants will receive the study medicines through an intravenous (IV) infusion (injected into the vein) at the study clinic. All treatments will take place at clinical trial sites, where trained medical staff will monitor participants during and after each visit.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2026
Longer than P75 for phase_1
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2025
CompletedFirst Posted
Study publicly available on registry
November 12, 2025
CompletedStudy Start
First participant enrolled
January 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 23, 2033
April 20, 2026
April 1, 2026
3.1 years
November 7, 2025
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
Through 90 days after the last study intervention; Up to approximately 5 years
Phase I: Number of participants with dose limiting toxicity (DLT)
Dose limiting toxicity based on dose limiting toxicity evaluable participants. The number of participants who experienced DLTs during the DLT observation period.
Through 90 days after the last study intervention; Up to approximately 5 years
Phase 2: Confirmed Objective Response Rate (ORR) per RECIST v1.1 by investigator
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.
Up to approximately 5 Years
Secondary Outcomes (7)
Phase I: Confirmed ORR per RECIST v1.1 by investigator
Up to approximately 5 Years
Disease Control Rate (DCR) per RECIST v1.1 by investigator
Up to approximately 5 years
Duration of Response (DOR) per RECIST v1.1 by investigator
Up to approximately 5 years
Progression Free Survival (PFS) per RECIST v1.1 by investigator
Up to approximately 5 years
Number of Participants With Clinical Laboratory Abnormalities
Through 90 days after the last study intervention; Up to approximately 5 years
- +2 more secondary outcomes
Other Outcomes (1)
Overall Survival (OS)
Up to approximately 5 years
Study Arms (2)
PF-08634404 + Sigvotatug Vedotin (Part A)
EXPERIMENTALParticipants will receive PF-08634404 in combination with Sigvotatug Vedotin.
PF-08634404 + Combination Agent 1 (Part B)
EXPERIMENTALParticipants will receive PF-08634404 in combination with other anticancer agents as per protocol.
Interventions
-Concentrate for solution for infusion
-Powder for concentrate for solution for infusion. Single use vial
-Powder for concentrate for solution for infusion. Single use vial.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (32)
Highlands Oncology Group, PA
Fayetteville, Arkansas, 72703, United States
Highlands Oncology Group, PA
Rogers, Arkansas, 72758, United States
Highlands Oncology Group, PA
Springdale, Arkansas, 72762, United States
Providence Medical Foundation
Fullerton, California, 92835, United States
Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center and Infusion Center
Fullerton, California, 92835, United States
Providence St. Jude Medical Center
Fullerton, California, 92835, United States
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, 80218, United States
BRCR Medical Center Inc.
Coral Springs, Florida, 33065, United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763, United States
BRCR Global - Tamarac
Tamarac, Florida, 33321, United States
Oncology Associates of Oregon, P.C.
Eugene, Oregon, 97401, United States
Dallas Cancer Specialists
Garland, Texas, 75042, United States
Southwest Oncology Associates
Houston, Texas, 77030, United States
Lumi Research
Houston, Texas, 77090, United States
US Oncology Investigational Products Center (IPC)
Irving, Texas, 75063, United States
Voyage Clinical
Sugar Land, Texas, 77479, United States
VCU Medical Center Gateway Building
Richmond, Virginia, 23219, United States
Virginia Commonwealth University
Richmond, Virginia, 23219, United States
VCU Health Stony Point
Richmond, Virginia, 23235, United States
Massey Cancer Center Clinical & Translational Research Lab
Richmond, Virginia, 23298, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
VCU Health Community Memorial Hospital
South Hill, Virginia, 23970, United States
VCU Health Tappahannock Hospital
Tappahannock, Virginia, 22560, United States
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191, Japan
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, 411-8777, Japan
Pan American Center for Oncology Trials, LLC
Rio Piedras, 00935, Puerto Rico
BRCR Global Puerto Rico - Hato Rey
San Juan, 00917, Puerto Rico
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Mackay Memorial Hospital
Taipei, 10449, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2025
First Posted
November 12, 2025
Study Start
January 30, 2026
Primary Completion (Estimated)
March 8, 2029
Study Completion (Estimated)
August 23, 2033
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.