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CarcinomaPhase 2NCT07489066

Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in Combination in Early-stage or Locally Advanced NSCLC

A Phase 2 study testing PF-08634404, Chemotherapy Regimen 1 and Chemotherapy Regimen 2 in people with Carcinoma and Non-Small-Cell Lung, run by Pfizer at 37 sites in 11 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. The study team wants to understand how well it works when given alone or with chemotherapy. The study is for adults with early stage or locally advanced non-small cell lung cancer (NSCLC) that may or may not be removable with surgery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PF-08634404, Chemotherapy Regimen 1 and Chemotherapy Regimen 2
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
37 sitesin 11 countries
Study dates
30 Jun 2026to 30 Jul 2031
Phase
Phase 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

  • 18 years of age or older at screening.
  • Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy
  • PD-L1 status available based on local testing results
  • Adequate organ function
  • Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1
  • Part A only: Participants must have newly diagnosed, previously untreated, pathologically confirmed early-stage or LA (Stage II or IIIA/B), squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) with disease that is considered resectable, as assessed by a multidisciplinary evaluation, which must include a thoracic surgeon who performs lung cancer surgery as a prominent part of his/her practice. The participant must be a candidate for neoadjuvant therapy followed by complete surgical resection.
  • Part B only: Participants must have pathologically confirmed early-stage or LA (Stage II or IIIA/B), squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) and have undergone complete surgical resection. The participant must be considered a candidate for adjuvant therapy and must not have achieved pCR with SOC neoadjuvant chemo-immunotherapy.
  • Part C only: Participants must have pathologically confirmed LA, unresectable (Stage III) squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) and have received ≥ 60 Gy of radiation and ≥ 2 cycles of definitive, platinum-based concurrent chemotherapy and achieved SD or better per RECIST 1.1.

Who cannot join

  • Participants with known EGFR and ALK AGAs; documented negative results for EGFR and ALK AGAs are required for participants with non-squamous histology.
  • Participants with CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression.
  • Participants with clinically significant risk of hemorrhage or fistula are excluded.
  • Participants with any 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.
  • Unresolved toxicities from prior anti-tumor therapy, that did not recover to NCI CTCAE v5.0 Grade 0 or 1.
  • Known to have a history of a severe allergy to any component of the study intervention, or a history of severe allergic reaction to chimeric or humanized antibody.
Show all 18Show fewer
  • History of allogeneic organ / hematopoietic stem cell transplantation.
  • Participants with any of the following respiratory conditions:
  • Evidence of noninfectious or drug-induced interstitial lung disease (ILD) or pneumonitis
  • Grade ≥3 pulmonary disease unrelated to underlying malignancy
  • History of uncontrolled comorbidities within 6 months prior to the first dose including uncontrolled cardiac and cerebrovascular conditions, hypertension, diabetes, significant vascular disease or arterial/severe venous thromboembolic events.
  • Major surgery < 4 weeks or minor surgery < 3 days prior to first dose of study intervention.
  • History of severe bleeding tendency or coagulation dysfunction
  • History of esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose.
  • Participants with acute, chronic or symptomatic infections including participants positive for active HIV, hepatitis B virus (HBV), or Hepatitis C virus (HCV).
  • Participants with history of immunodeficiency
  • Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior (in the past 5 years) or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.
  • Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.

Trial locations and contacts

37 sites in 11 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

37 sites in 11 countries

United States15 sites, 15 recruiting

  • New Mexico Oncology Hematology Consultants, Ltd

    Albuquerque, New Mexico, 87109

    Recruiting

  • University Cancer & Blood Center, LLC

    Athens, Georgia, 30607

    Recruiting

  • Nebraska Medicine- Bellevue Medical Center

    Bellevue, Nebraska, 68123

    Not yet recruiting

  • Hope and Healing Clinical Research

    Hinsdale, Illinois, 60521

    Recruiting

  • Clearview Cancer Institute (Crestwood)

    Huntsville, Alabama, 35801

    Recruiting

  • Clearview Cancer Institute

    Huntsville, Alabama, 35805

    Recruiting

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

    Recruiting

  • Cancer Partners of Nebraska

    Lincoln, Nebraska, 68516

    Recruiting

  • Hope and Healing Clinical Research

    New Lenox, Illinois, 60451

    Recruiting

  • Nebraska Medicine

    Omaha, Nebraska, 68105

    Not yet recruiting

  • Nebraska Medicine - Village Pointe

    Omaha, Nebraska, 68118

    Not yet recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Not yet recruiting

  • Stanford Cancer Institute

    Stanford, California, 94305

    Recruiting

  • Stanford Hospital and Clinics

    Stanford, California, 94305

    Recruiting

  • Stanford Hospital Investigational Drug Services

    Stanford, California, 94305

    Recruiting

Other trials in United States

Puerto Rico5 sites, 5 recruiting

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

    Bayamón, 00959

    Recruiting

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

    Manati, 00674

    Recruiting

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

    Ponce, 00730

    Recruiting

  • Hospital Oncologico Dr. Isaac Gonzalez Martinez

    Rio Piedras, 00935

    Recruiting

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

    San Juan, 00909

    Recruiting

Other trials in Puerto Rico

Taiwan5 sites, 5 recruiting

  • Chung Shan Medical University Hospital

    Taichung, 40201

    Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704

    Recruiting

  • National Taiwan University Hospital

    Taipei, 100

    Not yet recruiting

  • Taipei Medical University Hospital

    Taipei, 110

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Recruiting

Other trials in Taiwan

China4 sites, 4 recruiting

  • Beijing Cancer hospital

    Beijing, Beijing Municipality, 100142

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510180

    Recruiting

  • The Affiliated Cancer Hospital of Shandong First Medical University

    Jinan, Shandong, 250117

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Recruiting

Other trials in China

Germany2 sites, 2 recruiting

  • Marien Hospital Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40479

    Not yet recruiting

  • LungenClinic Grosshansdorf

    Großhansdorf, 22927

    Not yet recruiting

Other trials in Germany

Australia1 site, 1 recruiting

  • Western Health-Sunshine & Footscray Hospitals

    St Albans, Victoria, 3021

    Recruiting

Other trials in Australia

Hong Kong1 site, 1 recruiting

  • Prince of Wales Hospital

    Hong Kong

    Not yet recruiting

Other trials in Hong Kong

Israel1 site, 1 recruiting

  • Sourasky Medical Center

    Tel Aviv, TELL ABĪB, 6423906

    Recruiting

Other trials in Israel

Italy1 site, 1 recruiting

  • Casa di Cura Dott. Pederzoli

    Peschiera del Garda, Verona, 37019

    Not yet recruiting

Other trials in Italy

Poland1 site, 1 recruiting

  • Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii

    Wroclaw, 53-439

    Recruiting

Other trials in Poland

Spain1 site, 1 recruiting

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Majadahonda, 28222

    Recruiting

Other trials in Spain

About this study

Official title: AN INTERVENTIONAL, OPEN-LABEL, PHASE 2 STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY OR IN COMBINATION IN ADULT PARTICIPANTS WITH EARLY-STAGE RESECTABLE OR LOCALLY ADVANCED UNRESECTABLE NON-SMALL CELL LUNG CANCER

This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well it works when given alone or with chemotherapy. The study is for adults with early stage or locally advanced non-small cell lung cancer (NSCLC) that may or may not be removable with surgery.

The study is seeking participants who:

Read more
  • Are aged 18 years or older
  • Have either:
  • Early-stage or locally advanced (Stage II or IIIA/B) NSCLC and are a candidate for neoadjuvant therapy, followed by surgical removal of the tumor. Neoadjuvant therapy is a treatment given as a first step to shrink the tumor before surgery.
  • Early-stage or locally advanced (Stage II or IIIA/B) NSCLC and are a candidate for adjuvant therapy and did not achieve a pathological complete response (pCR) from approved treatment that was administered before surgery. Adjuvant therapy is an additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. pCR is defined as absence of viable tumor in all surgically removed samples.
  • Locally advanced (Stage III) NSCLC that may not be removable with surgery, was treated with concurrent chemoradiotherapy (cCRT), and is a candidate for additional treatment, otherwise known as consolidation therapy. cCRT is chemotherapy and radiation given simultaneously.
  • Be in good physical condition and have healthy organs based on medical tests.
  • Do not have known actionable changes in DNA

The study has 3 parts and each participant will be assigned to one part by their doctor based on their disease diagnosis:

  • Part A will test PF-08634404 given with chemotherapy in the neoadjuvant setting, followed by surgery.
  • Part B will test PF-08634404 alone in adults who already were treated with neoadjuvant chemo-immunotherapy, underwent surgery, and did not achieve pCR per tumor tissue pathology analysis. Neoadjuvant chemo-immunotherapy refers to the combination of chemotherapy with immunotherapy per local standard-of-care, given before surgical removal of the tumor.
  • Part C will test PF-08634404 alone in adults with unresectable disease who received cCRT and did not have progressive disease. Progressive disease refers to a condition that grows, spreads, or worsens.

All treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.

Being tested
PF-08634404, Chemotherapy Regimen 1, Chemotherapy Regimen 2
Keywords
early stage non small cell lung cancer, NSCLC, adjuvant NSCLC, locally advanced non small cell lung cancer, resectable NSCLC, unresectable NSCLC, neoadjuvant NSCLC, consolidation NSCLC, squamous NSCLC, non-squamous NSCLC
Medical subject headings
Carcinoma, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Lung Diseases

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

  • Chemotherapy Regimen 1Drug

    Injection for intravenous use

  • Chemotherapy Regimen 2Drug

    Injection for intravenous use

Study groups in NCT07489066
Study groupRoleWhat they receive
Part A: Neoadjuvant PF-08634404 + ChemotherapyExperimentalParticipants with treatment naïve early-stage or locally advanced, resectable NSCLC without Actionable Genomic Alterations (AGAs) who are candidates for neoadjuvant treatment will receive intravenous (IV) PF-08634404 in combination with chemotherapy.
Receives: Biological: PF-08634404; Drug: Chemotherapy Regimen 1; Drug: Chemotherapy Regimen 2
Part B: Adjuvant PF-08634404 MonotherapyExperimentalParticipants with early-stage or locally advanced, resectable NSCLC without AGAs who did not achieve pCR after standard-of-care (SOC) neoadjuvant chemo-immunotherapy and are candidates for adjuvant treatment will receive PF-08634404 IV.
Receives: Biological: PF-08634404
Part C: PF-08634404 Monotherapy Consolidation after Definitive ChemoradiotherapyExperimentalParticipants with locally advanced, unresectable NSCLC without AGAs who did not have progressive disease per RECIST 1.1 after definitive, platinum-based concurrent chemoradiotherapy (cCRT) and are candidates for consolidation treatment will receive PF-08634404 IV.
Receives: Biological: PF-08634404

What is being measured

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

  1. Number of Participants With Adverse Events (AEs)

    AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s).

    Measured: Through 90 days after the last dose of study intervention (Part A only: or 90 days after surgery, whichever is later)

  2. Part A: Surgical Feasibility Rate

    Surgical Feasibility rate is defined by the proportion of participants undergoing surgery and the proportion of participants with wound complications after surgery.

    Measured: Up to approximately 6 months after first dose

  3. Part A: Pathological Complete Response (pCR) rate per International Association for the Study of Lung Cancer (IASLC) guidelines as assessed by central pathology review

    pCR rate by central pathology review is defined as the proportion of participants having pCR as assessed by central pathologist. pCR is defined as the absence of residual tumor in surgical specimens

    Measured: Up to approximately 6 months after first dose

Secondary outcomes (13)

  1. Part A: Major Pathological Response (MPR) rate per IASLC guidelines as assessed by central pathology review

    MPR rate by central pathology review is defined as the proportion of participants having MPR as assessed by central pathologist or investigator respectively. MPR is defined as ≤10% residual tumor in surgical specimens.

    Measured: Up to approximately 6 months after first dose

  2. Part A: pCR rate per IASLC guidelines as assessed by investigator

    pCR rate by investigator is defined as the proportion of participants having pCR as assessed by investigator. pCR is defined as the absence of residual tumor in surgical specimens.

    Measured: Up to approximately 6 months after first dose

  3. Part A: MPR rate per IASLC guidelines as assessed by investigator

    MPR rate by investigator is defined as the proportion of participants having MPR as assessed by central pathologist or investigator respectively. MPR is defined as ≤10% residual tumor in surgical specimens.

    Measured: Up to approximately 6 months after first dose

  4. Part A: Event Free Survival (EFS) per RECIST v1.1 as assessed by investigator

    EFS is defined as time from the date of first dose to the first occurrence of disease progression precluding surgery, inability to resect the tumor, disease progression or recurrence after surgery per RECIST v1.1 as assessed by investigator, or death due to any cause.

    Measured: Up to approximately 5 years

  5. Part A: Objective Response Rate (ORR) per RECIST v1.1 as assessed by investigator at the completion of neoadjuvant therapy, prior to surgery

    ORR is defined as the proportion of participants with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) per RECIST v1.1.

    Measured: Up to approximately 5 years

  6. Part B: Disease Free Survival (DFS) per RECIST v1.1 as assessed by investigator

    DFS is defined as time from the date of first dose to the date of first documented disease progression or recurrence per RECIST v1.1 as assessed by investigator or death due to any cause, whichever occurs first

    Measured: Up to approximately 5 years

  7. Part C: Confirmed ORR per RECIST v1.1 as assessed by investigator

    Confirmed ORR is defined as the proportion of participants in the analysis population having a best overall response (BOR) of confirmed CR or confirmed PR according to RECIST v1.1 as assessed by investigator.

    Measured: Up to approximately 5 years

  8. Part C: Progression Free Survival (PFS) per RECIST v1.1 as assessed by investigator

    PFS is defined as the time from the date of first dose to the date of the first documentation of objective Progression Disease (PD) assessed by investigator per RECIST v1.1, or death due to any cause, whichever occurs first

    Measured: Up to approximately 5 years

  9. Overall Survival (OS)

    OS is defined as the time from the date of randomization to the date of death due to any cause. OS is secondary outcome measure in Phase 2 portion of the study.

    Measured: Up to approximately 5 years

  10. Rate of circulating tumor DNA (ctDNA) reduction or clearance

    Reduction in ctDNA is defined as a decrease in ctDNA burden from baseline to a specified on-treatment time point. ctDNA clearance is defined as a 100% reduction in ctDNA burden.

    Measured: Part A: Up to 18 months, Part B and Part C: Up to 37 days after the last dose of treatment

  11. Number of participants with Laboratory abnormalities

    Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0).

    Measured: Through 90 days after the last dose of study intervention (Part A only: or 90 days after surgery, whichever is later)

  12. Pharmacokinetics: Serum concentrations of PF-086344

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

  13. Incidence of antidrug antibody against PF-08634404

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

Timeline

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

  1. First posted23 Mar 2026
  2. Study start30 Jun 2026
  3. Primary completion29 Jul 2028 (estimated)
  4. Study completion30 Jul 2031 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07489066
Sponsor's protocol ID
C6461010
Other IDs
2025-524825-42-00, Symbiotic-Lung-10, 2025
Status last verified
Oct 2026
First submitted
17 Mar 2026
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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 2 study testing PF-08634404, Chemotherapy Regimen 1 and Chemotherapy Regimen 2 in people with Carcinoma and Non-Small-Cell Lung, run by Pfizer at 37 sites in 11 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 8 inclusion and 18 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 37 sites in United States, Puerto Rico, Taiwan, China, Germany and 6 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 phase mean?

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 Adverse Events (AEs) (time frame: Through 90 days after the last dose of study intervention (Part A only: or 90 days after surgery, whichever is later)). 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 NCT07489066.

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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