Study study type PathologyT1T0Patientssample sizesROB Results

Extensive stage SCLC (Es-SCLC) - maintenance (M) Extensive stage SCLC (Es-SCLC) Extensive stage SCLC (Es-SCLC) - maintenance (M)

versus placebo
nivolumab plus ipilimumab
CheckMate 451 (NI ; all population), 2019
  NCT02538666
RCTExtensive stage SCLC (Es-SCLC) - maintenance (M)nivolumab plus ipilimumabplacebopatients with extensive-stage disease small cell lung cancer (ED-SCLC) as maintenance therapy after completion of platinum-based chemotherapy279 / 275some concern
inconclusive
  • inconclusive 8 % decrease in deaths (OS) (PE)
  • suggested 28 % decrease in progression or deaths (PFS)

limited stage SCLC (ls-SCLC) - maintenance (M) limited stage SCLC (ls-SCLC) limited stage SCLC (ls-SCLC) - maintenance (M)

versus no additional treatment
nivolumab plus ipilimumab
STIMULI unpublished
  NCT02046733
RCTlimited stage SCLC (ls-SCLC) - maintenance (M)nivolumab plus ipilimumabno treatment addedlimited stage SCLC patients who had undergone chemoradiotherapy treated as consolidation treatment78 / 75NA
inconclusive
  • inconclusive 5 % decrease in deaths (OS) (PE)
  • inconclusive 2 % increase in progression or deaths (PFS) (PE)
  • statistically significant 3.1-fold increase in AE (grade 3-4)
The immunotherapy combination nivolumab plus ipilimumab did not significantly improve progression-free survival (PFS) or overall survival.