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Fig. 1 | BMC Cancer

Fig. 1

From: Thoracic radiotherapy plus Durvalumab in elderly and/or frail NSCLC stage III patients unfit for chemotherapy - employing optimized (hypofractionated) radiotherapy to foster durvalumab efficacy: study protocol of the TRADE-hypo trial

Fig. 1

Study design of the TRADE-hypo trial. Patients will be enrolled according to eligibility criteria and treated with either a hypofractionated TRT regimen (HYPO-group) or conventionally fractionated TRT (CON-group) in combination with durvalumab. For the HYPO-group, a safety stop-and-go phase with a 6 + 6 design precedes full enrollment. Whenever this arm is open for recruitment, patients will be allocated to this arm until the cohort is closed; whenever HYPO-arm is closed for Stop/ Go decision evaluation based on the toxicity assessment of this regimen 8 weeks after the end of TRT, patients are allocated to the CON-arm. When the study proceeds to expansion phase, patients will be allocated to treatment arms by randomization using “biased coin” algorithm. An efficacy interim analysis will be performed after 18 patients have been enrolled in each arm

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