Olaparib (LYNPARZA) Plus Durvalumab (IMFINZI) in EGFR-Mutated Adenocarcinomas That Transform to Small Cell Lung Cancer (SCLC) and Other Neuroendocrine Tumors

Conditions

• EGFR-Mutated Non-Small-Cell Lung Carcinoma
• Small Cell/Neuroendocrine

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Olaparib — DRUG
  Olaparib tablet will be administered at a total daily dose of 600 mg orally in two divided doses, approximately 12 hours apart.
• Durvalumab — DRUG
  Durvalumab will be administered intravenous (IV) into a peripheral or central vein on Day 1 of every cycle at a flat dose of 1,500 mg.
• EKG — DIAGNOSTIC_TEST
  Screening and all cycles Day 1 and Day 15 (+/- 3) days. One cycle is 28 days.
• Tumor biopsy — PROCEDURE
  Baseline and all cycles Day 15 (+/- 3) days. One cycle is 28 days.
• CT chest, abdomen and pelvis — DIAGNOSTIC_TEST
  Screening and baseline and every 8 (+/-1) weeks after start of therapy.
• MRI chest, abdomen and pelvis — DIAGNOSTIC_TEST
  Screening and baseline and every 8 (+/-1) weeks after start of therapy.

Study Details

Background: Lung cancers with epidermal growth factor receptor (EGFR) mutations may develop resistance to therapies targeting this protein by evolving/being transformed into small cell or neuroendocrine cancers. There are no standard treatments for it. Researchers want to see if a new combination of drugs can help. Objective: To see if the combination of durvalumab and olaparib will cause tumors to shrink. Eligibility: Adults age 18 and older who had EGFR-mutated non-small-cell lung carcinoma (NSCLC) that was treated and now transformed to SCLC or another neuroendocrine tumor. Design: Participants will be screened under a separate protocol. They may have a tumor biopsy. Participants will have a physical exam. They will have a review of their symptoms, their medicines, and their ability to do their normal activities. They will have blood tests. They will have an electrocardiogram to evaluate their heart. Participants will have a computed tomography (CT) scan, a series of x-rays taken of parts of the body. Participants will get durvalumab on Day 1 of each 28-day cycle. It is given through a small plastic tube that is put in an arm vein. They will take olaparib by mouth twice every day. They will keep a medicine diary. Participants will take the study drugs until their disease gets worse or they have unacceptable side effects. About 30 days after they stop taking the study drugs, participants will have a follow-up visit. Then they will be contacted every 6 months for the rest of their life....

Key Dates

Start date

Jul 7, 2021

Status verified

Jan 2025

Primary completion

Mar 22, 2023

Completion

Feb 27, 2024

Study Design

Enrollment

4 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: 1/Arm 1: Combination of Durvalumab and Olaparib
  Combination of durvalumab and olaparib

Primary Outcome Measure

Best Overall Response (BOR) [ Time Frame: Disease progression; an average of 53 days ]

Locations (1)

Find similar trials in Bethesda, MD