COVID-19 Update: See the latest on our visitor policy here. Learn More
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
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).
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.
Immunotherapy; Therapy (NOS)
AMP-514 (Durvalumab); CP-675,206 (tremelimumab); Durvalumab (); MEDI4736 (Durvalumab); Olaparib (Lynparza); tremelimumab ()
Back to top
Please call 1-888-663-3488 for support from a Moffitt representative. New Patients and Healthcare Professionals can submit an online form by selecting the appropriate button below. Existing patients can call 1-888-663-3488. Click here for a current list of insurances accepted at Moffitt.
NEW PATIENTS To request a new patient appointment, please fill out the online form or call 1-888-663-3488.
REFERRING PHYSICIANS Providers and medical staff can refer patients by submitting our online referral form.
Moffit now offers Virtual Visits for patients. If you are eligible for a virtual appointment, our scheduling team will discuss this option further with you.