A randomised open-label phase II trial of consolidation with nivolumab and ipilimumab in limited-stage SCLC after chemo-radiotherapy
STIMULI: Small cell lung carcinoma trial with nivolumab and ipilimumab in limited disease
Chemo-radiotherapy is the current standard treatment approach in limited-stage (stage I-IIIB) small cell lung carcinoma (SCLC) with a median survival of 16 to 24 month and only 15 – 25% long-term survivors.
Nivolumab and ipilimumab are humanized monoclonal antibody that target the immune checkpoint receptors PD-1 and CTLA-4, respectively and inhibit the interaction with their ligands.
The aim of the trial was to evaluate whether nivolumab plus ipilimumab consolidation treatment after completion of standard chemo-radiotherapy and prophylactic cranial irradiation is superior in terms of overall survival and progression-free survival compared to standard chemo-radiotherapy and prophylactic cranial irradiation alone.
Trial Scheme
Trial Treatment
Patients who are randomised to the experimental arm will receive nivolumab 1mg/kg and ipilimumab 3 mg/kg in the induction phase, followed by 240mg nivolumab as maintenance treatment for 1 year. A maximum of one cycle of platinum based chemotherapy can be administered before enrolment. In this case radiotherapy should optimally start concomitantly with chemotherapy cycle 2 and no later than cycle 3.