Recruiting

Phase 1

Phase 2

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

Sponsor:

Pfizer

Code:

NCT07227298

Conditions

Advanced/Metastatic Non-Small Cell Lung Cancer

Carcinoma, Non-Small Cell Lung

Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PF-08634404

Sigvotatug Vedotin

Combination Agent 1

Study Details

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.

Conditions

Advanced/Metastatic Non-Small Cell Lung Cancer

Carcinoma, Non-Small Cell Lung

Non-Small Cell Lung Cancer

Study ID

NCT07227298

Start date

Jan 30, 2026

Status verified date

Jul, 2026

Completion date

Aug 23, 2033

Anticipated

Primary completion date

Mar 8, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

162 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PF-08634404 + Sigvotatug Vedotin (Part A)

Participants will receive PF-08634404 in combination with Sigvotatug Vedotin.

experimental: PF-08634404 + Combination Agent 1 (Part B)

Participants will receive PF-08634404 in combination with other anticancer agents as per protocol.

Interventions

PF-08634404

-Concentrate for solution for infusion

Sigvotatug Vedotin

-Powder for concentrate for solution for infusion. Single use vial

Combination Agent 1

-Powder for concentrate for solution for infusion. Single use vial.

Primary outcome measure

Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Through 90 days after the last study intervention; Up to approximately 5 years ]
Phase I: Number of participants with dose limiting toxicity (DLT) [ Time Frame: 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 [ Time Frame: Up to approximately 5 Years ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Highlands Oncology Group, PA

Recruiting

Fayetteville, Arkansas, United States, 72703

Highlands Oncology Group, PA

Recruiting

Rogers, Arkansas, United States, 72758

Highlands Oncology Group, PA

Recruiting

Springdale, Arkansas, United States, 72762

Providence Medical Foundation

Recruiting

Fullerton, California, United States, 92835

Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center and Infusion Center

Recruiting

Fullerton, California, United States, 92835

Providence St. Jude Medical Center

Recruiting

Fullerton, California, United States, 92835

Valkyrie Clinical Trials (Additional Site Pharmacy Storage Suite)

Recruiting

Los Angeles, California, United States, 90067

Valkyrie Clinical Trials

Recruiting

Los Angeles, California, United States, 90067

Mission Community Hospital (Satellite Site)

Recruiting

Panorama City, California, United States, 91402

Rocky Mountain Cancer Centers, LLP

Recruiting

Denver, Colorado, United States, 80218

BRCR Medical Center Inc.

Recruiting

Coral Springs, Florida, United States, 33065

Mid Florida Hematology and Oncology Center

Recruiting

Orange City, Florida, United States, 32763

Orlando Health Ambulatory Care Center

Recruiting

Orlando, Florida, United States, 32806

Orlando Health Cancer Institute

Recruiting

Orlando, Florida, United States, 32806

Orlando Health Orlando Regional Medical Center

Recruiting

Orlando, Florida, United States, 32806

BRCR Global - Tamarac

Recruiting

Tamarac, Florida, United States, 33321

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

John Theurer Cancer Center at Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Newman Street Imaging

Recruiting

Hackensack, New Jersey, United States, 07601

John Theurer Cancer Center at JSUMC

Recruiting

Neptune City, New Jersey, United States, 07753

John Theurer Cancer Center at From Road

Recruiting

Paramus, New Jersey, United States, 07652

Heart Center Glenpointe

Recruiting

Teaneck, New Jersey, United States, 07666

Montefiore Medical Center- Montefiore Medical Park

Recruiting

The Bronx, New York, United States, 10461

Oncology Associates of Oregon, P.C.

Recruiting

Eugene, Oregon, United States, 97401

Dallas Cancer Specialists

Recruiting

Garland, Texas, United States, 75042

Southwest Oncology Associates

Recruiting

Houston, Texas, United States, 77030

Lumi Research

Recruiting

Houston, Texas, United States, 77090

US Oncology Investigational Products Center (IPC)

Recruiting

Irving, Texas, United States, 75063

Voyage Clinical

Recruiting

Sugar Land, Texas, United States, 77479

VCU Medical Center Gateway Building

Recruiting

Richmond, Virginia, United States, 23219

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23219

VCU Health Stony Point

Recruiting

Richmond, Virginia, United States, 23235

Massey Cancer Center Clinical & Translational Research Lab

Recruiting

Richmond, Virginia, United States, 23298

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

VCU Health Community Memorial Hospital

Recruiting

South Hill, Virginia, United States, 23970

VCU Health Tappahannock Hospital

Recruiting

Tappahannock, Virginia, United States, 22560

More Information

Sponsor

Pfizer

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

non-small cell lung cancer
NSCLC
advanced solid tumors
metastatic non-small cell lung cancer
locally advanced non-small cell lung cancer
squamous non-small cell lung cancer
non-squamous non-small cell lung cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Pfizer on 2026-07-22.