Study on Chemotherapy and Radiation with Pembrolizumab, Followed by Pembrolizumab and Olaparib, for Newly Diagnosed Limited-Stage Small Cell Lung Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT04624204

This clinical trial is exploring whether adding pembrolizumab and olaparib to standard chemotherapy and radiation can improve treatment outcomes for patients with limited-stage small cell lung cancer (LS-SCLC). The study aims to see if this combination can help patients live longer compared to those receiving only chemotherapy and radiation.

Patient Parameters

Program Overview

Researchers are investigating new treatment options for Limited-Stage Small Cell Lung Cancer (LS-SCLC), a type of lung cancer that hasn't spread beyond the lungs. This study is testing if the combination of pembrolizumab and olaparib, along with chemotherapy and radiation, can be more effective in treating LS-SCLC. The goal is to find out if patients receiving this combination live longer than those who only receive chemotherapy and radiation.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Small Cell Lung Cancer (SCLC) based on lab tests.
  • Cancer is in a limited stage (Stage I-III) and can be treated with radiation.
  • No signs of cancer spreading to other parts of the body.
  • At least one tumor that can be measured by scans.
  • No previous treatment for LS-SCLC.
  • Not expected to need surgery to remove the tumor during the study.
  • Must provide a tumor sample before starting treatment.
  • Good overall health with a performance status score of 0 or 1.
  • Expected to live at least 6 more months.
  • Healthy organ function.
  • Participants of childbearing potential must use birth control during and after treatment.
  • Must be 18 years or older.
  • Men must not donate sperm during and after treatment.
  • Women must not breastfeed during and after treatment for specified periods.

Exclusion Criteria

  • History or signs of certain blood disorders like myelodysplastic syndrome or acute myeloid leukemia.
  • Previous treatment with specific immune therapies or PARP inhibitors like olaparib.
  • Major surgery within 4 weeks before starting the study (except for minor procedures like placing a catheter).
  • Participation in another clinical trial within 4 weeks before starting this study.
  • Immune system deficiencies or use of high-dose steroids or other immune-suppressing drugs recently.
  • Another active cancer needing treatment in the past 5 years, except for certain skin or bladder cancers.
  • Severe allergies to study drugs or their ingredients.
  • Active autoimmune diseases needing treatment in the past 2 years.
  • History of lung diseases requiring steroids.
  • Active infections needing treatment.
  • Known HIV or active Hepatitis B or C infections.

Locations

FACILITYZIPCITYSTATE
Ironwood Cancer & Research Centers ( Site 0007)85224ChandlerArizona
Loma Linda University Cancer Center ( Site 0011)92350Loma LindaCalifornia
Georgetown University ( Site 0017)20007Washington D.C.District of Columbia
Moffitt Cancer Center ( Site 0137)33612TampaFlorida
University of Chicago Medical Center ( Site 0136)60637ChicagoIllinois
Fort Wayne Medical Oncology and Hematology ( Site 0034)46804Fort WayneIndiana
University of Kentucky Chandler Medical Center ( Site 0138)40536LexingtonKentucky
Overton Brooks VAMC ( Site 0041)71101ShreveportLouisiana
Harry & Jeanette Weinberg Cancer Institute ( Site 0045)21237BaltimoreMaryland
VA Ann Arbor Healthcare System ( Site 0050)48105Ann ArborMichigan

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