The primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population under the treatment policy strategy.~The secondary objectives are:~To test with a one-sided type I error of 2.5% whether brain MRI surveillance is superior in terms of cognitive failure free survival (CFFS) compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the study population.~To test with a one-sided type I error of 2.5% whether brain MRI surveillance is superior in terms of global health status/QoL and cognitive functioning according to EORTC QLQ-C30 questionnaire compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the study population.~To evaluate the frequency and severity of toxicities according to CTCAE v5.0 in the two arms in the treated population (i.e. patients who have started treatment).~The exploratory objectives are:~To compare OS and CFFS between the arms within the subgroups of patients with LS and ES disease.~To compare OS and CFFS between the arms within the subgroups: HA-PCI or not, first-line immunotherapy or not, memantine or not.~To compare cognitive failure free survival (CFFS) rate at 12 months after randomization between the arms.~To compare the cumulative incidence of cognitive failures with death as a competing risk between the arms.~To compare brain-metastasis-free survival (BMFS) between the arms.~To compare progression free survival (PFS) between the arms.~To compare time to brain-metastasis-attributed death (TBMAD) between the arms.~To compare other QoL scales according to EORTC QLQ-C30 and QLQ-BN20 questionnaires between arms.~To evaluate the cost-effectiveness of MRI surveillance alone versus MRI surveillance combined with PCI.~To collect blood for biobanking.
In this phase III study, the primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population.