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Clinical Trial 19942
Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT03923270
Phase: Phase I
Prinicipal Investigator: Alberto Chiappori
Study 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
Summary
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).
Objective
The safety lead-in phase I is to confirm the recommended phase II dose of durvalumab combinations (arms B and C) among patients treated with thoracic XRT (30 Gy in 10 fractions) following standard chemotherapy (4-6 cycles of platinum-based chemotherapy). Part 2: Phase IB is to evaluate the safety of durvalumab monotherapy and/or combinations with thoracic XRT after standard chemotherapy and to determine the preliminary activity of durvalumab monotherapy and/or combinations with thoracic XRT after standard treatment chemotherapy using 6 months PFS rate as surrogate endpoint. Secondary Objectives: To estimate the median PFS among patients treated with durvalumab monotherapy and/or combinations with thoracic XRT after standard chemotherapy. To estimate the median OS and 1-year OS rate among patients treated with durvalumab monotherapy and/or combinations with thoracic XRT after standard chemotherapy. Exploratory Objectives: To perform rigorous evaluation of (potential) predictive and/or prognostic biomarkers in peripheral blood. To bank and store available formalin-fixed, paraffin-embedded (FFPE) diagnostic tumor biopsy specimens to perform future (potential) predictive and/or prognostic biomarker studies.
Therapies
Medications
AMP-514 (Durvalumab); CP-675,206 (tremelimumab); Durvalumab (); MEDI4736 (Durvalumab); Olaparib (Lynparza); tremelimumab ()
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