Study on Olaparib and Durvalumab for EGFR-Mutated Lung Cancers That Change to Small Cell Lung Cancer and Other Neuroendocrine Tumors

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04538378

Provider View

This clinical trial is testing a new combination of drugs, olaparib and durvalumab, to see if they can help shrink tumors in adults whose lung cancer with EGFR mutations has transformed into small cell lung cancer or other neuroendocrine tumors.

Patient Parameters

Program Overview

Lung cancers with EGFR mutations can sometimes change into more aggressive forms like small cell lung cancer (SCLC) or neuroendocrine tumors, making them resistant to standard treatments. This study aims to find out if a combination of two drugs, durvalumab and olaparib, can help reduce these tumors. Participants will receive these medications and be monitored for their response and any side effects.

Description

This study focuses on lung cancers with specific genetic changes (EGFR mutations) that have transformed into small cell lung cancer (SCLC) or other neuroendocrine tumors. These cancers are aggressive and often resistant to standard treatments. The study will test a combination of two drugs, durvalumab and olaparib, to see if they can effectively shrink these tumors.

Participants will receive durvalumab through an IV every 28 days and take olaparib pills twice daily. The treatment will continue until the cancer worsens or side effects become too severe. Participants will be closely monitored with regular check-ups, blood tests, and scans to assess their response to the treatment.

The study aims to provide new treatment options for patients with these challenging types of cancer, as there are currently no standard therapies available. By combining these two drugs, researchers hope to improve outcomes for patients with EGFR-mutated lung cancers that have transformed into SCLC or neuroendocrine tumors.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with lung cancer that started as EGFR-mutated non-small-cell lung carcinoma and has changed into small cell or neuroendocrine tumors.
  • Must have received or refused platinum-based chemotherapy for the transformed cancer.
  • Must have measurable disease that can be tracked.
  • Must be in relatively good health with an ECOG performance status of 0 to 2.
  • Must have adequate blood, liver, and kidney function as shown by specific tests.
  • Women of childbearing potential must use effective contraception during the study and for 6 months after, and men must use contraception for 3 months after treatment.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Currently receiving other investigational treatments.
  • Recent major surgery or cancer treatment within the last 2 weeks.
  • Recent radiation therapy within 24 hours or high-dose chest radiation within 2 weeks.
  • Taking medications that strongly affect liver enzymes (CYP3A4).
  • History of autoimmune disease requiring steroids or primary immunodeficiency.
  • Recent use of immunosuppressive medication, except for certain low-dose steroids.
  • History of blood disorders like myelodysplastic syndrome or leukemia.
  • Severe allergic reactions to similar drugs.
  • Heart conditions or active infections like tuberculosis or hepatitis.
  • HIV-positive patients on antiretroviral therapy, unless stable for over 5 years.
  • History of organ or bone marrow transplant.
  • Uncontrolled medical conditions or psychiatric issues.
  • Unable to swallow pills or have digestive issues affecting drug absorption.
  • Pregnant or breastfeeding women.

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