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A Study of Olaparib and Low Dose Radiotherapy for Small Cell Lung Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of Olaparib and Low Dose Radiotherapy for Small Cell Lung Cancer

A Phase I Study of Olaparib and Low Dose Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer

NCT03532880•Memorial Sloan Kettering Cancer Center

Summary

The purpose of this study is to test the safety of a new medication, Olaparib, combined with radiation therapy for participants with small cell lung cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histological documented diagnosis of SCLC confirmed by a MSKCC pathologist.
•Documented extensive disease, defined as any tumor beyond the above limited disease definition, including ipsilateral lung metastases and malignant pleural effusion
•Completion of induction chemotherapy with a minimum of 4 and no more than 6 cycles of a platinum agent and etoposide within 8 weeks of trial initiation.
•No disease progression (i.e.SD or better response per treating physician descretion) at the completion of chemotherapy.
•Age 18 years or older.
•Intrathoracic disease should be encompassable in acceptable radiation fields per investigator clinical judgement.
•Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnosfsky Performance Score (KPS) \>/= 70
•Patients must have adequately recovered from any adverse events associated with prior immune-chemotherapy
•Adequate organ and marrow function, including:
•1. Haemoglobin \>/= 8.0 g/dL with no blood transfusion in the past 28 days.
+16 more criteria

Exclusion Criteria

•Untreated brain metastases.
•Pneumonitis
•Previous radiotherapy to thorax (prior breast RT is permitted).
•Patient is not a candidate for or declines consolidative thoracic radiotherapy.
•Patients receiving any systemic chemotherapy or thoracic radiotherapy within 3 weeks prior to study treatment.
•Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
•Previous enrolment in the present study.
•Exposure to an investigational product within 30 days or 5 half lives (whichever is longer) prior to start of the current study drug.
•Any previous treatment with PARP inhibitor, including olaparib, for the treatment of small cell lung cancer
•Resting ECG with QTc \> 470 msec on 2 or more time points within a 24 hour period or a documented family history of long QT syndrome.
+13 more criteria

Locations (9)

Baptist Alliance Miami Cancer Institute

Miami, Florida, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Rockville Centre

Rockville Centre, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Key Dates

Start Date

July 12, 2018

Primary Completion Date

February 4, 2025

Completion Date

February 4, 2025

Last Updated

February 7, 2025

Enrollment

ACTUAL participants

Conditions

Small-cell Lung CancerSmall Cell Lung Carcinoma

Interventions

Olaparib Pill 50 mg

DRUG

Olaparib Pill 100 mg

DRUG

Olaparib Pill 150 mg

DRUG

Olaparib Pill 200 mg

DRUG

Olaparib Pill 250 mg

DRUG

Olaparib Pill 300 mg

DRUG

Radiotherapy

RADIATION

Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations

NCT07336732

Non-Small-Cell Lung Cancer

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RECRUITINGPHASE1/PHASE2

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

NCT04585750

Advanced Solid TumorAdvanced Malignant Neoplasm+28 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Olaparib and Low Dose Radiotherapy for Small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

A Study of LY4175408 in Participants With Advanced Cancer

Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer

A Study of Stereotactic Radiosurgery (SRS) for People With Lung Cancer That Has Spread to the Brain

A Study of MGC026 in Participants With Advanced Solid Tumors