Study on PF-08634404 with Chemotherapy for Adults with Advanced or Metastatic Non-Small Cell Lung Cancer

Sponsor: Pfizer

Sponsor score: 60

ClinicalTrials ID:NCT07222566

This clinical trial is testing a new medicine called PF-08634404, combined with chemotherapy, to see if it works better than the current standard treatment for adults with advanced or metastatic non-small cell lung cancer (NSCLC).

Patient Parameters

Program Overview

The purpose of this study is to find out if a new medicine, PF-08634404, when used with chemotherapy, is more effective than the current standard treatment (pembrolizumab with chemotherapy) for adults with non-small cell lung cancer (NSCLC) that is either locally advanced or has spread to other parts of the body. Participants will be divided into two groups based on their type of lung cancer: squamous or non-squamous NSCLC. Each participant will be randomly assigned to receive either the new study medicine PF-08634404 with chemotherapy or the standard treatment pembrolizumab with chemotherapy. The treatment will be given through IV infusions in cycles, and participants will continue receiving it as long as it is effective and side effects are manageable. Regular visits will be scheduled for treatment, health checks, and tests to monitor the cancer's response.

Eligibility Criteria

Inclusion Criteria

  • Be 18 years or older.
  • Have a confirmed diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC) that cannot be completely removed by surgery or cured with chemoradiotherapy.
  • Have available tumor tissue samples for testing.
  • Have PD-L1 status results from local testing.
  • Have measurable disease based on specific criteria.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have an expected survival of at least 12 weeks.

Exclusion Criteria

  • Have known genetic changes in the cancer that have available first-line treatments.
  • Have active brain lesions, unless they have been treated and are stable.
  • Have a significant risk of bleeding or fistula.
  • Have had another cancer within the past 3 years, unless it was treated and there is no residual disease.
  • Have unresolved side effects from previous cancer treatments.
  • Have a history of severe allergies to study medications.
  • Have had an organ or stem cell transplant.
  • Have certain lung conditions or severe respiratory diseases.
  • Have uncontrolled health conditions like heart disease or diabetes.
  • Have had major surgery recently.
  • Have a history of severe bleeding disorders or gastrointestinal issues.
  • Have active infections like HIV, hepatitis B, or hepatitis C.
  • Have a history of immune system deficiencies.
  • Have medical or psychiatric conditions that increase the risk of participation.
  • Have had previous treatments for advanced NSCLC, including certain immunotherapies or radiotherapy.
  • Are currently taking certain medications or treatments that are not allowed during the study.
  • Are pregnant, breastfeeding, or not willing to use contraception if of childbearing potential.

Locations

FACILITYZIPCITYSTATE
Highlands Oncology Group72762SpringdaleArkansas
Sansum Clinic93463California CityCalifornia
Cancer Care Centers of Brevard, Inc.32935MelbourneFlorida
Mid Florida Hematology and Oncology Center32763Orange CityFlorida
Hope and Healing Cancer Services60451New LenoxIllinois
Illinois CancerCare, P.C.61615PeoriaIllinois
Hematology Oncology Associates of Rockland10960NyackNew York
Tennessee Cancer Specialists37909KnoxvilleTennessee
SCRI Oncology Partners37203NashvilleTennessee
Texas Oncology - West Texas79902El PasoTexas

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