NCT03923270

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Small Cell Lung Cancer Extensive Stage
• Small-cell Lung Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-06-06
• Primary completion: 2023-06-01
• Completion: 2026-12-01
• First posted: 2019-04-22
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study