Olaparib (LYNPARZA) Plus Durvalumab (IMFINZI) in EGFR-Mutated Adenocarcinomas That Transform to Small Cell Lung Cancer (SCLC) and Other Neuroendocrine Tumors
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|ClinicalTrials.gov Identifier: NCT04538378|
Recruitment Status : Recruiting
First Posted : September 4, 2020
Last Update Posted : September 5, 2021
Lung cancers with 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.
To see if the combination of durvalumab and olaparib will cause tumors to shrink.
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.
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....
|Condition or disease||Intervention/treatment||Phase|
|EGFR-Mutated Non-Small-Cell Lung Carcinoma Small Cell/Neuroendocrine||Drug: Olaparib Drug: Durvalumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Olaparib (LYNPARZA) Plus Durvalumab (IMFINZI) in EGFR-Mutated Adenocarcinomas That Transform to Small Cell Lung Cancer (SCLC) and Other Neuroendocrine Tumors.|
|Actual Study Start Date :||July 7, 2021|
|Estimated Primary Completion Date :||December 31, 2025|
|Estimated Study Completion Date :||December 31, 2026|
Experimental: 1/Arm 1
Combination of durvalumab and olaparib
Olaparib tablet will be administered at a total daily dose of 600 mg orally in two divided doses, approximately 12 hours apart.
Durvalumab will be administered IV into a peripheral or central vein on Day 1 of every cycle at a flat dose of 1,500 mg.
- Best overall response [ Time Frame: Disease progression ]The clinical response rate of evaluable patients will be reported along with a 95% confidence interval.
- Progression-free survival (PFS) [ Time Frame: Disease progression ]PFS and OS will be estimated by the Kaplan-Meier method. The median PFS and OS will be reported along with a 95% confidence interval.
- Safety and tolerability of a combination [ Time Frame: Treatment phase ]Patients will be assessed for toxicity by reporting the grades of toxicity and the type of toxicity observed for all patients.
- Overall survival (OS) [ Time Frame: Death ]PFS and OS will be estimated by the Kaplan-Meier method. The median PFS and OS will be reported along with a 95% confidence interval.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04538378
|Contact: Linda C Sciuto, R.N.||(240) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Anish Thomas, M.D.||National Cancer Institute (NCI)|