Back to search results

Symbiotic-Lung-01: PF-08634404 with Chemotherapy for Lung Cancer

This study is investigating whether a new treatment, PF-08634404 combined with chemotherapy, is more effective than the current standard treatment (pembrolizumab with chemotherapy) for adults with non-small cell lung cancer (NSCLC). This type of lung cancer is either locally advanced (spread to nearby tissues) or has spread to other parts of the body (metastatic). The study will measure how long participants live (Overall Survival) and how long they live without their cancer getting worse (Progression Free Survival). You may be able to join if you are 18 or older, have locally advanced or metastatic NSCLC, and are not a candidate for surgery or curative chemoradiotherapy.

Study design
This interventional study plans to enroll 1410 adult participants. It compares PF-08634404 with chemotherapy against pembrolizumab with chemotherapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for Overall Survival for approximately 39 months and for Progression Free Survival for approximately 32 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07222566

Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Recruiting
PHASE3Ages 18+InterventionalTreatment
Pfizer
~1,410 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:PF-08634404PembrolizumabChemotherapy Regimen 1Chemotherapy Regimen 2

At a glance

Recruiting sites
419 of 440 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival
Measured over Approximately 39 months
+1 more outcome measured

Conditions

Advanced Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Carcinoma, Non-Small-Cell Lung (NSCLC)
Metastatic Non Small Cell Lung Cancer
Lung Cancer

Explore related trials

Lung Non-Small Cell CarcinomaProgrammed Cell Death 1 Ligand 1

Where it's being run

440 sites across 135 states
Florida48
Texas46
California20
Tennessee14
Illinois13
Minnesota10
Ohio10
Taiwan10

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

18 years of age or older at screening.
Have pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV)squamous or non-squamous NSCLC and not be a candidate for complete surgical resection and curative concurrent/sequential chemoradiotherapy (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer Tumor, lymph nodes, metastasis (TNM) staging system).
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
Measurable disease based on RECIST v1.1 per investigator.
Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1
Expected survival ≥12 weeks

Exclusion

Participants with known actionable genomic alteration (AGAs), including estimated glomerular filtration rate (EGFR), anaplastic lymphoma kinase (ALK), Repressor of Silencing 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), v-raf murine sarcoma viral oncogene homolog B1 (BRAF), rearranged during transfection (RET), and mesenchymal-epithelial transition (MET), for which there are available first-line therapies per local standard-of-care (SOC) are ineligible. Documented negative results for EGFR, ALK, and ROS1 AGAs are required for participants with non-squamous histology.
Known active CNS lesions are excluded. Participants with definitively treated brain metastases (surgery and/or radiotherapy) may be eligible. Clinically inactive brain metastases of longest diameter \< 1 cm are permitted.
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.
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.
Previous systemic anti-tumor therapy including:
Prior immune-related AE that led to anti-PD-(L)1 treatment discontinuation, adverse events from prior immunotherapy not improved to Grade 1 before screening, or required treatment with systemic immunosuppressive therapy.
Prior and concomitant therapy:
Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.

What this trial measures

  • Overall SurvivalApproximately 39 months

    Overall survival defined as the time from the date of randomization to the date of death due to any cause.

  • Progression Free Survival (PFS) assessed by blinded independent central review (BICR)Approximately 32 months

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