2022 World Conference on Lung Cancer (ePosters)-EP14.03-001. DARES: A Phase II Trial of Durvalumab and Ablative Radiation in Extensive Stage Small Cell Lung Cancer

EP14.03-001. DARES: A Phase II Trial of Durvalumab and Ablative Radiation in Extensive Stage Small Cell Lung Cancer

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A new phase II clinical trial called DARES is being conducted to investigate whether the addition of radiation therapy (RT) to chemotherapy and Durvalumab can improve progression-free survival (PFS) in patients with newly diagnosed extensive-stage small cell lung cancer (ES-SCLC). Checkpoint inhibitors, such as Durvalumab, have transformed the treatment landscape for ES-SCLC patients, but combining them with RT may further enhance their efficacy. RT is known to provide effective local control of metastasis and can also debulk tumors, relieving tumor-related immunosuppression and preventing early treatment failure. Previous studies have shown benefits in overall survival (OS) and PFS with the addition of local therapy in metastatic non-small cell lung cancer. Additionally, the safety and efficacy of multi-site ablative RT in combination with immunotherapy have been demonstrated in prospective trials. <br /><br />The trial will enroll treatment-naive ES-SCLC patients with a performance status of 0-2 who have at least one measurable lesion suitable for ablative radiation. The primary endpoint of the trial is PFS, with a hypothesized improvement from 5 months (based on historic control data) to 8 months with the addition of ablative RT. Secondary endpoints include OS, time to second-line therapy, response rate, and the rate of grade 3 adverse events. Exploratory analysis will be conducted using peripheral blood, stool, nasal, and buccal samples obtained at different time points during the trial.<br /><br />The trial aims to enroll 49 patients across four institutions and will begin accrual in September 2022. The research is funded with support from AstraZeneca Pharmaceuticals, LP. If successful, this study could provide valuable insights into the potential benefits of combining RT with chemotherapy and immunotherapy in the treatment of ES-SCLC.

Asset Subtitle

Aditya Juloori

Meta Tag

Speaker Aditya Juloori

Topic Small Cell Lung Cancer and Neuro-endocrine Tumours - RT

Keywords

DARES

phase II clinical trial

radiation therapy

chemotherapy

Durvalumab

progression-free survival

extensive-stage small cell lung cancer

checkpoint inhibitors

metastatic non-small cell lung cancer

ablative radiation