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

NCT03923270 Phase 1 ACTIVE_NOT_RECRUITING

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).

Details

Lead sponsor	H. Lee Moffitt Cancer Center and Research Institute
Phase	Phase 1
Status	ACTIVE_NOT_RECRUITING
Enrolment	25
Start date	2019-06-06
Completion	2026-12

Conditions

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

Interventions

• Durvalumab
• Tremelimumab
• Olaparib Pill
• Thoracic Radiotherapy
• Tremelimumab

Primary outcomes

• Phase 1: Unacceptable Serious Adverse Events (SAEs) — 13 weeks
  Unacceptable toxicity status at the end of 13-week safety observation period with unacceptable toxicity defined as: * Any grade 4 immune related adverse event (irAE), * Any ≥ grade 3 noninfectious pneumonitis, * Any ≥ grade 3 colitis, * Any grade 3 irAE, excluding colitis or pneumonitis, that does not downgrade to grade 2 within 7 days after onset of the event despite optimal medical management including systemic corticosteroids or does not downgrade to ≤ grade 1 or baseline within 14 days, * Liver transaminase elevation \> 8 × Upper Limit of Normal (ULN) or total bilirubin \> 5 × ULN * Any ≥ grade 3 non-irAE with exceptions per protocol
• Phase IB: Progression Free Survival — 6 months
  Progression Free Survival (PFS) defined as the duration from date of registration to date of first documentation of progression assessed by local investigator or symptomatic deterioration or death due to any cause. Patients last known to be alive are censored at date of last contact.

Countries

United States