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

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT03923270
Phase
PHASE1
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Participants in all arms will be administered 1500 mg of Durvalumab intravenously every 4 weeks.
  • Tremelimumab — DRUG
    Participants in arm B will be administered 75 mg of Tremelimumab intravenously every 4 weeks for up to 4 doses.
  • Olaparib Pill — DRUG
    Participants in arm C will be self-administer 300 mg of Olaparib orally.
  • Thoracic Radiotherapy — RADIATION
    Thoracic Radiotherapy will be administered at 3 Gray units X 10 fractions
  • Tremelimumab — DRUG
    Participants in arm D will be administered 300 mg of Tremelimumab intravenously in 1 single dose

Study Details

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).

Key Dates

Start date
Jun 6, 2019
Status verified
Mar 2026
Primary completion
Jun 1, 2023
Completion
Dec 31, 2026

Study Design

Enrollment
25 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Thoracic Radiotherapy plus Durvalumab
    This Arm is a standard of care Arm. Patients will receive thoracic radiotherapy (30 Gray units total, 3 Gray units X 10 fractions), then in 2-3 weeks begin 1500 mg intravenously of Durvalumab every 4 weeks for up to 13 doses
  • Experimental: Thoracic Radiotherapy plus Durvalumab and 75mg Tremelimumab
    Patients will receive thoracic radiotherapy (30 Gray units total, 3 Gray units X 10 fractions), then in 2-3 weeks begin 1500 mg intravenously of Durvalumab every 4 weeks for up to 4 doses and 75mg intravenously of Tremelimumab every 4 weeks for up to 4 doses
  • Experimental: Thoracic Radiotherapy plus Durvalumab and Olaparib
    Patients will receive thoracic radiotherapy (30 Gray units total, 3 Gray units X 10 fractions), then in 2-3 weeks begin 1500 mg intravenously of Durvalumab every 4 weeks and 300 mg orally of Olaparib twice a day
  • Experimental: Thoracic Radiotherapy plus Durvalumab and 300mg Tremelimumab
    Patients will receive thoracic radiotherapy (30 Gray units total, 3 Gray units X 10 fractions), then in 2-3 weeks begin 1500 mg intravenously of Durvalumab every 4 weeks and 300 mg Tremelimumab IV x 1 (single dose)

Primary Outcome Measure

Phase 1: Unacceptable Serious Adverse Events (SAEs) [ Time Frame: 13 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-

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