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ACTIVE NOT RECRUITING
NCT03923270
PHASE1

Radiotherapy and Durvalumab/Durvalumab Combo (Tremelimumab/Olaparid) for Small Cell Lung Cancer

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

Summary

This is a randomized multi-arm trial evaluating the safety and efficacy of thoracic radiation therapy followed by either durvalumab as monotherapy or in combination with tremelimumab or olaparib in participants with Extensive-Stage Disease Small Cell Lung Cancer (ES-SCLC) who have completed a first-line platinum-based chemotherapy regimen and achieved ongoing complete response (CR), partial response (PR) or stable disease (SD).

Official title: Sequential Maintenance With Thoracic Radiotherapy and Durvalumab (MEDI4736) Monotherapy or Durvalumab (MEDI 4736) Combinations (Tremelimumab or Olaparib) in Patients With Extensive Stage-Small Cell Lung Cancer After First Line Platinum Based Chemotherapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2019-06-06

Completion Date

2026-12

Last Updated

2026-04-01

Healthy Volunteers

No

Interventions

DRUG

Durvalumab

Participants in all arms will be administered 1500 mg of Durvalumab intravenously every 4 weeks.

DRUG

Tremelimumab

Participants in arm B will be administered 75 mg of Tremelimumab intravenously every 4 weeks for up to 4 doses.

DRUG

Olaparib Pill

Participants in arm C will be self-administer 300 mg of Olaparib orally.

RADIATION

Thoracic Radiotherapy

Thoracic Radiotherapy will be administered at 3 Gray units X 10 fractions

DRUG

Tremelimumab

Participants in arm D will be administered 300 mg of Tremelimumab intravenously in 1 single dose

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States