Olaparib + Durvalumab for Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

Overseen ByAnish Thomas, M.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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....

Eligibility Criteria

Adults over 18 with EGFR-mutated non-small-cell lung cancer that has transformed into small cell or neuroendocrine tumors after treatment. They must have stable brain metastases if present, measurable disease, and adequate organ function. Women of childbearing potential and men must agree to contraception.

Inclusion Criteria

I have had or refused platinum-based chemotherapy for my cancer.

I can take care of myself but might not be able to do heavy physical work.

My liver is functioning well according to recent tests.

My lung cancer changed to a different type after treatment with a specific medication.

My kidney function is within the required range for the study.

I am 18 years old or older.

Exclusion Criteria

I have an autoimmune disease that needs steroids or a primary immunodeficiency.

I have had an organ or bone marrow transplant.

I am not pregnant or breastfeeding.

I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.

I do not have any severe illnesses that could worsen with the study treatment.

I have received high-dose chest radiation within the last 2 weeks.

I have not had cancer treatment or major surgery in the last 2 weeks.

I have received palliative radiation within the last 24 hours.

Participant Groups

The trial is testing a combination of two drugs: Olaparib taken orally twice daily and Durvalumab given intravenously every 28 days. The goal is to see if these drugs can shrink the tumors in patients whose lung cancer has changed form.

1Treatment groups

Experimental Treatment

Group I: 1/Arm 1: Combination of Durvalumab and OlaparibExperimental Treatment6 Interventions

Combination of durvalumab and olaparib

Durvalumab is already approved in European Union, United States, Japan for the following indications:

🇪🇺 Approved in European Union as Imfinzi for: