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Taking people in TaiwanPhase 2

PF-08634404 alone or with chemotherapy in early or locally advanced non-small cell lung cancer

Tests PF-08634404 in adults with early or locally advanced non-small cell lung cancer.

Key facts

Who runs it
Pfizer
Where
Taichung, Tainan, and Taipei, TaiwanSee the 5 sitesAlso in 12 other countries, 51 sites
Registry title
Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in Combination in Early-stage or Locally Advanced NSCLC
Status
Recruiting
Phase
Phase 2
People taking part
120 people, planned
Started
30 Jun 2026
Expected to end
30 Jul 2031
Type of study
Interventional, 3 groups
Treatments tested
  • PF-08634404
  • Chemotherapy Regimen 1
  • Chemotherapy Regimen 2
Record updated
8 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with early-stage or locally advanced non-small cell lung cancer (NSCLC). They join one of three parts, depending on their treatment history and whether surgery is possible.

Age
18 years or older
Sex
All sexes
Disease stage
Stage II or IIIA/B squamous or non-squamous NSCLC. Part A: newly diagnosed, untreated, can be removed by surgery. Part B: tumor already removed by surgery. Part C: Stage III that cannot be removed by surgery.
Earlier treatment
Part A: no earlier treatment. Part B: had standard chemo-immunotherapy before surgery but no pathological complete response (no complete tumor clearance), then complete surgery. Part C: had at least 60 Gy of radiation plus at least 2 cycles of platinum-based chemotherapy given together, and the disease did not get worse.
Biomarker or test result
Tumor tissue and PD-L1 test result must be available. People with non-squamous cancer need a documented negative test for EGFR and ALK changes.

Main reasons for not taking part

  • Known EGFR or ALK gene changes
  • Brain or spinal cord metastases
  • Another cancer within the last 3 years
  • Interstitial lung disease or pneumonitis
  • Active HIV, hepatitis B or hepatitis C infection

The registry criteria, word for word

Show all 24 criteriaShow less

Who can take part

  • 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 take part

  • Unresolved toxicities from prior anti-tumor therapy, that did not recover to NCI CTCAE v5.0 Grade 0 or 1
  • 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 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 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
  • 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 severe bleeding tendency or coagulation dysfunction
  • 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
  • Participants with known EGFR and ALK AGAs; documented negative results for EGFR and ALK AGAs are required for participants with non-squamous histology
  • 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
  • Participants with CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression
  • Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures

Where in Taiwan

Also in 12 other countries, 51 sites

  • Chung Shan Medical University HospitalTaichung, TaiwanTaking people
  • National Cheng Kung University HospitalTainan, TaiwanTaking people
  • National Taiwan University HospitalTaipei, TaiwanNot yet recruiting
  • Taipei Medical University HospitalTaipei, TaiwanTaking people
  • Taipei Veterans General HospitalTaipei, TaiwanTaking people

About the trial

What the trial wants to find out

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 full original descriptionShow less

The study is seeking participants who:

* 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.

The 3 groups in the trial

  • Part A: Neoadjuvant PF-08634404 + ChemotherapyTreatment being tested

    Participants 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.

    Treatment: PF-08634404, Chemotherapy Regimen 1, and Chemotherapy Regimen 2

  • Part B: Adjuvant PF-08634404 MonotherapyTreatment being tested

    Participants 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.

    Treatment: PF-08634404

  • Part C: PF-08634404 Monotherapy Consolidation after Definitive ChemoradiotherapyTreatment being tested

    Participants 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.

    Treatment: PF-08634404

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Plain-language title
PF-08634404 alone or with chemotherapy in early or locally advanced non-small cell lung cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
8 October 2026