Trial of EP0057, a Nanoparticle Camptothecin With Olaparib in People With Relapsed/Refractory Small Cell Lung Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02769962

Provider View

This study is testing a new treatment combining EP0057, a nanoparticle chemotherapy drug, with olaparib, a medication that may help prevent cancer cells from repairing themselves. The trial aims to find out if this combination is safe and effective for treating small cell lung cancer that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

EP0057 is a new type of chemotherapy drug that travels through the blood and releases its active ingredient inside cancer cells. Olaparib is a drug that may help stop cancer cells from fixing the damage caused by chemotherapy. This study is looking at how safe it is to use these two drugs together and how well they work in treating small cell lung cancer (SCLC). Participants will receive both drugs in 28-day cycles, with EP0057 given through an IV every two weeks and olaparib taken as pills twice a day. The study will include regular visits for tests and monitoring.

Description

Small cell lung cancer (SCLC) is a fast-growing cancer that often returns after initial treatment. This study is exploring a new treatment approach using EP0057, a nanoparticle drug that targets cancer cells, and olaparib, which may enhance the effects of chemotherapy by preventing cancer cells from repairing themselves. The study is divided into two phases: Phase I focuses on finding the safest dose of the drug combination, while Phase II evaluates how well the treatment works in shrinking tumors and prolonging survival. Participants will receive the treatment in cycles, with regular check-ups to monitor their health and the cancer's response. The study will also collect blood, hair, and tumor samples to better understand how the treatment affects the body.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with small cell lung cancer that has returned or not responded to previous treatments.
  • Must have a confirmed diagnosis of small cell lung cancer.
  • Must have received at least one standard chemotherapy treatment and/or an immune therapy.
  • Must have measurable disease according to specific medical criteria.
  • Must be in good overall health with a performance status score of 0, 1, or 2.
  • Must have normal organ and bone marrow function as indicated by specific blood tests.
  • Women of childbearing potential and men must agree to use effective contraception during the study and for 120 days after the last dose of study drugs.
  • Must be willing to comply with study procedures and attend all scheduled visits.

Exclusion Criteria

  • Currently receiving any other investigational treatments.
  • Have ongoing side effects from previous cancer treatments, except for hair loss or mild nerve damage.
  • Have previously been treated with olaparib or similar drugs.
  • Have certain blood disorders or active lung inflammation.
  • Have allergies to the study drugs.

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