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Advanced/Metastatic Non-Small Cell Lung CancerPhase 1/2NCT07227298

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

A Phase 1/2 study testing PF-08634404, Sigvotatug Vedotin and PF-08046054/SGN-PDL1V in people with Advanced/Metastatic Non-Small Cell Lung Cancer and Carcinoma, Non-Small Cell Lung, run by Pfizer at 104 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PF-08634404, Sigvotatug Vedotin and PF-08046054/SGN-PDL1V
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
104 sitesin 9 countries
Study dates
30 Jan 2026to 23 Aug 2033
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

104 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

104 sites in 9 countries

United States55 sites, 55 recruiting

  • Rocky Mountain Cancer Centers,LLP

    Aurora, Colorado, 80012

    Recruiting

  • BRCR Medical Center Inc.

    Coral Springs, Florida, 33065

    Recruiting

  • Rocky Mountain Cancer Centers,LLP

    Denver, Colorado, 80218

    Recruiting

  • Oncology Associates of Oregon, P.C.

    Eugene, Oregon, 97401

    Recruiting

  • Highlands Oncology Group, PA

    Fayetteville, Arkansas, 72703

    Recruiting

  • Providence Medical Foundation

    Fullerton, California, 92835

    Recruiting

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

    Fullerton, California, 92835

    Recruiting

  • Providence St. Jude Medical Center

    Fullerton, California, 92835

    Recruiting

  • Dallas Cancer Specialists

    Garland, Texas, 75042

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Recruiting

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Recruiting

  • Newman Street Imaging

    Hackensack, New Jersey, 07601

    Recruiting

  • Southwest Oncology Associates

    Houston, Texas, 77030

    Recruiting

  • Lumi Research

    Houston, Texas, 77090

    Recruiting

  • US Oncology Investigational Products Center (IPC)

    Irving, Texas, 75063

    Recruiting

  • Scripps Clinic Torrey Pines (Scripps Cancer Center)

    La Jolla, California, 92037

    Recruiting

  • Scripps Green Hospital

    La Jolla, California, 92037

    Recruiting

  • Scripps Shiley Pavilion

    La Jolla, California, 92037

    Recruiting

  • Moffitt Cancer Center- Speros

    Land O' Lakes, Florida, 34638

    Not yet recruiting

  • Rocky Mountain Cancer Centers,LLP

    Lone Tree, Colorado, 80124

    Recruiting

  • START Los Angeles, LLC

    Los Angeles, California, 90025

    Recruiting

  • LACN Century City

    Los Angeles, California, 90067

    Recruiting

  • Valkyrie Clinical Trials (Additional Site Pharmacy Storage Suite)

    Los Angeles, California, 90067

    Recruiting

  • Valkyrie Clinical Trials (Additional Site Suite)

    Los Angeles, California, 90067

    Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

    Recruiting

  • John Theurer Cancer Center at JSUMC

    Neptune City, New Jersey, 07753

    Recruiting

  • Jack & Sheryl Morris Cancer Center

    New Brunswick, New Jersey, 08901

    Not yet recruiting

  • Robert Wood Johnson University Hospital (RWJBH)

    New Brunswick, New Jersey, 08901

    Not yet recruiting

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08901

    Not yet recruiting

  • Rutgers Cancer Institute

    New Brunswick, New Jersey, 08901

    Not yet recruiting

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida, 32763

    Recruiting

  • Orlando Health Ambulatory Care Center

    Orlando, Florida, 32806

    Recruiting

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

    Recruiting

  • Orlando Health Orlando Regional Medical Center

    Orlando, Florida, 32806

    Recruiting

  • Mission Community Hospital (Satellite Site)

    Panorama City, California, 91402

    Recruiting

  • John Theurer Cancer Center at From Road

    Paramus, New Jersey, 07652

    Recruiting

  • VCU Medical Center Gateway Building

    Richmond, Virginia, 23219

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23219

    Recruiting

  • VCU Health Stony Point

    Richmond, Virginia, 23235

    Recruiting

  • Massey Cancer Center Clinical & Translational Research Lab

    Richmond, Virginia, 23298

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

    Recruiting

  • Highlands Oncology Group, PA

    Rogers, Arkansas, 72758

    Recruiting

  • Moffitt Cancer Center - SouthShore

    Ruskin, Florida, 33570

    Not yet recruiting

  • VCU Health Community Memorial Hospital

    South Hill, Virginia, 23970

    Recruiting

  • Highlands Oncology Group, PA

    Springdale, Arkansas, 72762

    Recruiting

  • Voyage Clinical

    Sugar Land, Texas, 77479

    Recruiting

  • BRCR Global - Tamarac

    Tamarac, Florida, 33321

    Recruiting

  • Moffitt Cancer Center - International Plaza

    Tampa, Florida, 33607

    Not yet recruiting

  • Moffitt Cancer Center - McKinley Campus

    Tampa, Florida, 33612

    Not yet recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Not yet recruiting

  • Moffitt McKinley Hospital

    Tampa, Florida, 33612

    Not yet recruiting

  • VCU Health Tappahannock Hospital

    Tappahannock, Virginia, 22560

    Recruiting

  • Heart Center Glenpointe

    Teaneck, New Jersey, 07666

    Recruiting

  • Montefiore Medical Center- Montefiore Medical Park

    The Bronx, New York, 10461

    Recruiting

  • Moffitt Cancer Center - Wesley Chapel

    Wesley Chapel, Florida, 33544

    Not yet recruiting

Other trials in United States

Spain16 sites, 16 recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [barcelona], 08035

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalunya [cataluña], 08041

    Recruiting

  • Hospital Universitario Puerta del Mar

    Cadiz, 11009

    Recruiting

  • Hospital Universitario San Cecilio

    Granada, 18016

    Recruiting

  • HT Médica Jaen LAs Nieves

    Jaén, Andalusia, 23007

    Recruiting

  • Hospital Universitario de Jaen

    Jaén, 23007

    Recruiting

  • Hospital Jerez de la Frontera

    Jerez de la Frontera, Cádiz, 11407

    Recruiting

  • Hospital Nuestra Señora del Rosario

    Madrid, Madrid, Comunidad de, 280006

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041

    Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040

    Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, Málaga, 29010

    Recruiting

  • Clínica Radiólogica Mario Gallegos

    Málaga, Málaga, 29016

    Recruiting

  • Cadpet Malaga

    Málaga, 29006

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    Recruiting

  • VIVO Capuchinos

    Seville, 41009

    Recruiting

  • Fundación Instituto Valenciano de Oncología

    Valencia, Valenciana, Comunitat, 46009

    Not yet recruiting

Other trials in Spain

China8 sites, 8 recruiting

  • Beijing Cancer hospital

    Beijing, Beijing Municipality, 100142

    Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Not yet recruiting

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Not yet recruiting

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, 317000

    Recruiting

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

    Wuhan, Hubei, 430030

    Recruiting

Other trials in China

Japan6 sites, 6 recruiting

  • Nippon Medical School Hospital

    Bunkyo-ku, Tokyo, 113-8603

    Not yet recruiting

  • Tokyo Metropolitan Komagome Hospital

    Bunkyo-ku, Tokyo, 113-8677

    Recruiting

  • Kansai Medical University Hospital

    Hirakata, Osaka, 573-1191

    Recruiting

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

    Recruiting

  • Shizuoka Cancer Center

    Nagaizumi-cho, Shizuoka, 411-8777

    Recruiting

  • Sendai Kousei Hospital

    Sendai, Miyagi, 9810914

    Not yet recruiting

Other trials in Japan

Taiwan6 sites, 6 recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

    Recruiting

  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung City, 83301

    Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704

    Recruiting

  • National Taiwan University Hospital

    Taipei, 100

    Recruiting

  • Mackay Memorial Hospital

    Taipei, 10449

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Recruiting

Other trials in Taiwan

France4 sites, 4 recruiting

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

    Bordeaux, Aquitaine, 33076

    Recruiting

  • Centre Georges François Leclerc

    Dijon, CÔTE D'OR, 21079

    Recruiting

  • Institut Paoli-Calmettes

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

    Recruiting

  • Groupe hospitalier Paris saint Joseph

    Paris, Île-de-France Region, 75014

    Recruiting

Other trials in France

Germany3 sites, 3 recruiting

  • Marien Hospital Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40479

    Recruiting

  • Krankenhaus Nordwest GmbH

    Frankfurt am Main, Hesse, 60488

    Recruiting

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

    Recruiting

Other trials in Germany

Italy3 sites, 3 recruiting

  • Azienda Sanitaria Territoriale Pesaro Urbino (AST PU)

    Fano, Pesaro AND Urbino, 61032

    Not yet recruiting

  • IRCCS Istituto Nazionale dei Tumori Regina Elena

    Roma, ROME, 00144

    Not yet recruiting

  • Ospedale Isola Tiberina - Gemelli Isola

    Roma, ROME, 00186

    Not yet recruiting

Other trials in Italy

Puerto Rico3 sites, 3 recruiting

  • Pan American Center for Oncology Trials, LLC - Mayaguez

    Mayagüez, 00680

    Recruiting

  • Pan American Center for Oncology Trials, LLC

    Rio Piedras, 00935

    Recruiting

  • BRCR Global Puerto Rico - Hato Rey

    San Juan, 00917

    Recruiting

Other trials in Puerto Rico

About this study

Official title: 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

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:

Read more
  • Be 18 years or older
  • Participants with advanced non-small cell lung cancer (NSCLC), a type of lung cancer that has spread to other parts of the body

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 will test PF-08634404 with a medicine called PF-08046054/SGN-PDL1V

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.

Being tested
PF-08634404, Sigvotatug Vedotin, PF-08046054/SGN-PDL1V
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
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-08634404Biological

    Also called SSGJ-707

    -Concentrate for solution for infusion

  • Sigvotatug VedotinBiological

    Also called SGN-B6A, PF-08046047

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

  • PF-08046054/SGN-PDL1VBiological

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

Study groups in NCT07227298
Study groupRoleWhat they receive
PF-08634404 + PF-08046054/SGN-PDL1V (Part B)ExperimentalParticipants will receive PF-08634404 in combination with other anticancer agents as per protocol.
Receives: Biological: PF-08634404; Biological: PF-08046054/SGN-PDL1V
PF-08634404 + Sigvotatug Vedotin (Part A)ExperimentalParticipants will receive PF-08634404 in combination with Sigvotatug Vedotin.
Receives: Biological: PF-08634404; Biological: Sigvotatug Vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through 90 days after the last study intervention; Up to approximately 5 years

  2. 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.

    Measured: Through 90 days after the last study intervention; Up to approximately 5 years

  3. 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.

    Measured: Up to approximately 5 Years

Secondary outcomes (7)

  1. Phase I: Confirmed 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.

    Measured: Up to approximately 5 Years

  2. Disease Control Rate (DCR) per RECIST v1.1 by investigator

    DCR by investigator assessment is defined as the proportion of participants with CR or PR with confirmation, or Stable Disease (SD) by investigator assessment per RECIST version 1.1.

    Measured: Up to approximately 5 years

  3. Duration of Response (DOR) per RECIST v1.1 by investigator

    DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.

    Measured: Up to approximately 5 years

  4. Progression Free Survival (PFS) per RECIST v1.1 by investigator

    Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective PD assessed by investigator per RECIST v1.1, or death due to any cause, whichever occurs first.

    Measured: Up to approximately 5 years

  5. Number of Participants With Clinical Laboratory Abnormalities

    Measured: Through 90 days after the last study intervention; Up to approximately 5 years

  6. Pharmacokinetics (PK): Serum concentration of PF-08634404 with anticancer agents

    To characterize the pharmacokinetics (PK) of PF-08634404 with anticancer agents.

    Measured: Up to 37 days after the last dose of treatment

  7. Incidence of Anti-Drug Antibody (ADA) against PF-08634404 with anticancer agents

    To characterize the immunogenicity of PF-08634404 with anticancer agents.

    Measured: Up to 37 days after the last dose of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2025
  2. Study start30 Jan 2026
  3. Primary completion8 Mar 2029 (estimated)
  4. Study completion23 Aug 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
162 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07227298
Sponsor's protocol ID
C6461020
Other IDs
2025-523526-40-00, Symbiotic-Lung-20, 2025
Status last verified
Oct 2026
First submitted
7 Nov 2025
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PF-08634404, Sigvotatug Vedotin and PF-08046054/SGN-PDL1V in people with Advanced/Metastatic Non-Small Cell Lung Cancer and Carcinoma, Non-Small Cell Lung, run by Pfizer at 104 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in United States, Spain, China, Japan, Taiwan and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07227298.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

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