Symbiotic-Lung-10: Study on PF-08634404 Alone or with Chemotherapy for Early-stage or Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
Sponsor: Pfizer
ClinicalTrials ID:NCT07489066
This study is exploring a new medicine called PF-08634404 to see how well it works alone or with chemotherapy in adults with early-stage or locally advanced non-small cell lung cancer (NSCLC).
Patient Parameters
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Program Overview
The purpose of this study is to learn more about a new medicine called PF-08634404. Researchers want to see how well it works when given alone or with chemotherapy in adults with early-stage or locally advanced non-small cell lung cancer (NSCLC) that may or may not be removable with surgery. Participants will be assigned to one of three parts of the study based on their specific cancer diagnosis. The study will take place at clinical sites where medical teams will monitor participants during and after each visit.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have available tumor tissue from a biopsy.
- Have PD-L1 status results from local testing.
- Have healthy organs and good physical condition based on medical tests.
- Have an ECOG performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Part A: Newly diagnosed, untreated early-stage or locally advanced NSCLC that can be removed by surgery, and eligible for neoadjuvant therapy.
- Part B: Early-stage or locally advanced NSCLC that has been surgically removed, eligible for adjuvant therapy, and did not achieve a complete response from prior treatment.
- Part C: Locally advanced NSCLC that cannot be removed by surgery, has received specific radiation and chemotherapy, and has not worsened.
Exclusion Criteria
- Have known changes in EGFR and ALK genes (for non-squamous NSCLC).
- Have cancer spread to the brain or spinal cord.
- Have a high risk of bleeding or fistula.
- Have had another cancer within the last 3 years or have residual disease from a previous cancer.
- Have unresolved side effects from previous cancer treatments.
- Have severe allergies to study medications.
- Have had an organ or stem cell transplant.
- Have certain lung diseases or severe lung conditions.
- Have uncontrolled health conditions like heart disease or diabetes.
- Have had major surgery within 4 weeks or minor surgery within 3 days before starting the study.
- Have a history of severe bleeding or blood clotting issues.
- Have certain gastrointestinal issues or infections like HIV, hepatitis B, or hepatitis C.
- Have a history of immune system problems.
- Have any medical or psychiatric conditions that could increase risks or make participation inappropriate.
- Are breastfeeding or unwilling to use contraception if of childbearing potential.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Hope and Healing Clinical Research | 60521 | Hinsdale | Illinois |
| Hope and Healing Clinical Research | 60451 | New Lenox | Illinois |
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