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Pfizer launches early trial of PF-08634404 combo for tough lung cancers

NCT ID NCT07227298

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 11, 2026 · Updated 6 times

Summary

This study tests a new experimental drug called PF-08634404 combined with other cancer medicines in people with advanced non-small cell lung cancer that has spread and can't be surgically removed. The trial has two parts: one combining PF-08634404 with sigvotatug vedotin, and another with a different anticancer agent. Researchers will monitor safety, side effects, and whether the tumors shrink. About 162 adults with advanced NSCLC are being recruited at clinical trial sites.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PF-08634404 (also called SSGJ-707) combined with sigvotatug vedotin or another anticancer agent
What this could lead to
If it works, this could point toward a new combination treatment for advanced non-small cell lung cancer that has spread and can't be removed by surgery.
What could go wrong
This is an early-phase trial (Phase 1b/2) with only 162 participants, so the results may not apply to everyone. The main goal is safety, and it's too soon to know if the combination will actually shrink tumors or improve survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 162 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Aug 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced/metastatic non-small cell lung cancer Carcinoma, non-small-cell lung Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    87 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Sanitaria Territoriale Pesaro Urbino (AST PU)

    NOT_YET_RECRUITING

    Fano, Pesaro AND Urbino, 61032, Italy

  • BRCR Global - Tamarac

    RECRUITING

    Tamarac, Florida, 33321, United States

  • BRCR Global Puerto Rico - Hato Rey

    RECRUITING

    San Juan, 00917, Puerto Rico

  • BRCR Medical Center Inc.

    RECRUITING

    Coral Springs, Florida, 33065, United States

  • Beijing Cancer hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Cadpet Malaga

    RECRUITING

    Málaga, 29006, Spain

  • Centre Georges François Leclerc

    RECRUITING

    Dijon, CÔTE D'OR, 21079, France

  • Chang Gung Memorial Hospital at Kaohsiung

    RECRUITING

    Kaohsiung City, 83301, Taiwan

  • Clínica Radiólogica Mario Gallegos

    RECRUITING

    Málaga, Málaga, 29016, Spain

  • Dallas Cancer Specialists

    RECRUITING

    Garland, Texas, 75042, United States

  • Fundación Instituto Valenciano de Oncología

    NOT_YET_RECRUITING

    Valencia, Valenciana, Comunitat, 46009, Spain

  • HT Médica Jaen LAs Nieves

    RECRUITING

    Jaén, Andalusia, 23007, Spain

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Heart Center Glenpointe

    RECRUITING

    Teaneck, New Jersey, 07666, United States

  • Highlands Oncology Group, PA

    RECRUITING

    Fayetteville, Arkansas, 72703, United States

  • Highlands Oncology Group, PA

    RECRUITING

    Rogers, Arkansas, 72758, United States

  • Highlands Oncology Group, PA

    RECRUITING

    Springdale, Arkansas, 72762, United States

  • Hospital Clinico San Carlos

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Jerez de la Frontera

    RECRUITING

    Jerez de la Frontera, Cádiz, 11407, Spain

  • Hospital Nuestra Señora del Rosario

    RECRUITING

    Madrid, Madrid, Comunidad de, 280006, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, Barcelona [barcelona], 08035, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Madrid, Comunidad de, 28041, Spain

  • Hospital Universitario Puerta del Mar

    RECRUITING

    Cadiz, 11009, Spain

  • Hospital Universitario San Cecilio

    RECRUITING

    Granada, 18016, Spain

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, 41009, Spain

  • Hospital Universitario Virgen de la Victoria

    RECRUITING

    Málaga, Málaga, 29010, Spain

  • Hospital Universitario de Jaen

    RECRUITING

    Jaén, 23007, Spain

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, Catalunya [cataluña], 08041, Spain

  • IRCCS Istituto Nazionale dei Tumori Regina Elena

    NOT_YET_RECRUITING

    Roma, ROME, 00144, Italy

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

    RECRUITING

    Bordeaux, Aquitaine, 33076, France

  • Institut Paoli-Calmettes

    RECRUITING

    Marseille, Provence-Alpes-Côte d'Azur Region, 13273, France

  • Jiangsu Province Hospital

    NOT_YET_RECRUITING

    Nanjing, Jiangsu, 210029, China

  • John Theurer Cancer Center at From Road

    RECRUITING

    Paramus, New Jersey, 07652, United States

  • John Theurer Cancer Center at Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • John Theurer Cancer Center at JSUMC

    RECRUITING

    Neptune City, New Jersey, 07753, United States

  • Kansai Medical University Hospital

    RECRUITING

    Hirakata, Osaka, 573-1191, Japan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    RECRUITING

    Kaohsiung City, 807, Taiwan

  • LACN Century City

    RECRUITING

    Los Angeles, California, 90067, United States

  • Lumi Research

    RECRUITING

    Houston, Texas, 77090, United States

  • Mackay Memorial Hospital

    RECRUITING

    Taipei, 10449, Taiwan

  • Marien Hospital Düsseldorf

    RECRUITING

    Düsseldorf, North Rhine-Westphalia, 40479, Germany

  • Massey Cancer Center Clinical & Translational Research Lab

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Mid Florida Hematology and Oncology Center

    RECRUITING

    Orange City, Florida, 32763, United States

  • Mission Community Hospital (Satellite Site)

    RECRUITING

    Panorama City, California, 91402, United States

  • Montefiore Medical Center- Montefiore Medical Park

    RECRUITING

    The Bronx, New York, 10461, United States

  • National Cheng Kung University Hospital

    RECRUITING

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 100, Taiwan

  • Newman Street Imaging

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Oncology Associates of Oregon, P.C.

    RECRUITING

    Eugene, Oregon, 97401, United States

  • Orlando Health Ambulatory Care Center

    RECRUITING

    Orlando, Florida, 32806, United States

  • Orlando Health Cancer Institute

    RECRUITING

    Orlando, Florida, 32806, United States

  • Orlando Health Orlando Regional Medical Center

    RECRUITING

    Orlando, Florida, 32806, United States

  • Ospedale Isola Tiberina - Gemelli Isola

    NOT_YET_RECRUITING

    Roma, ROME, 00186, Italy

  • Pan American Center for Oncology Trials, LLC

    RECRUITING

    Rio Piedras, 00935, Puerto Rico

  • Pan American Center for Oncology Trials, LLC - Mayaguez Office

    RECRUITING

    Mayagüez, 00680, Puerto Rico

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100730, China

  • Providence Medical Foundation

    RECRUITING

    Fullerton, California, 92835, United States

  • Providence St. Jude Medical Center

    RECRUITING

    Fullerton, California, 92835, United States

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

    RECRUITING

    Fullerton, California, 92835, United States

  • Rocky Mountain Cancer Centers,LLP

    RECRUITING

    Aurora, Colorado, 80012, United States

  • Rocky Mountain Cancer Centers,LLP

    RECRUITING

    Denver, Colorado, 80218, United States

  • Rocky Mountain Cancer Centers,LLP

    RECRUITING

    Lone Tree, Colorado, 80124, United States

  • START Los Angeles, LLC

    RECRUITING

    Los Angeles, California, 90025, United States

  • Scripps Clinic Torrey Pines (Scripps Cancer Center)

    RECRUITING

    La Jolla, California, 92037, United States

  • Scripps Green Hospital

    RECRUITING

    La Jolla, California, 92037, United States

  • Scripps Shiley Pavilion

    RECRUITING

    La Jolla, California, 92037, United States

  • Sendai Kousei Hospital

    NOT_YET_RECRUITING

    Sendai, Miyagi, 9810914, Japan

  • Shanghai Chest Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200030, China

  • Shizuoka Cancer Center

    RECRUITING

    Nagaizumi-cho, Shizuoka, 411-8777, Japan

  • Southwest Oncology Associates

    RECRUITING

    Houston, Texas, 77030, United States

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 11217, Taiwan

  • Taizhou Hospital of Zhejiang Province

    RECRUITING

    Taizhou, Zhejiang, 317000, China

  • Tokyo Metropolitan Komagome Hospital

    RECRUITING

    Bunkyo-ku, Tokyo, 113-8677, Japan

  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430030, China

  • US Oncology Investigational Products Center (IPC)

    RECRUITING

    Irving, Texas, 75063, United States

  • Universitaetsklinikum Freiburg

    RECRUITING

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • VCU Health Community Memorial Hospital

    RECRUITING

    South Hill, Virginia, 23970, United States

  • VCU Health Stony Point

    RECRUITING

    Richmond, Virginia, 23235, United States

  • VCU Health Tappahannock Hospital

    RECRUITING

    Tappahannock, Virginia, 22560, United States

  • VCU Medical Center Gateway Building

    RECRUITING

    Richmond, Virginia, 23219, United States

  • VIVO Capuchinos

    RECRUITING

    Seville, 41009, Spain

  • Valkyrie Clinical Trials

    RECRUITING

    Los Angeles, California, 90067, United States

  • Valkyrie Clinical Trials (Additional Site Pharmacy Storage Suite)

    RECRUITING

    Los Angeles, California, 90067, United States

  • Valkyrie Clinical Trials (Additional Site Suite)

    RECRUITING

    Los Angeles, California, 90067, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23219, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Voyage Clinical

    RECRUITING

    Sugar Land, Texas, 77479, United States

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