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 alone
CheckMate 451 (N ; all population), 2019
  NCT02538666
RCTExtensive stage SCLC (Es-SCLC) - maintenance (M)nivolumabplacebopatients with extensive-stage disease small cell lung cancer (ED-SCLC) as maintenance therapy after completion of platinum-based chemotherapy280 / 275some concern
inconclusive
  • suggested 33 % decrease in progression or deaths (PFS)
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)

Extensive stage SCLC (Es-SCLC) - 1st Line (L1) Extensive stage SCLC (Es-SCLC) Extensive stage SCLC (Es-SCLC) - 1st Line (L1)

versus etoposide plus platin
durvalumab plus etoposide and platin
CASPIAN (D ; all population), 2019
  NCT03043872
RCTExtensive stage SCLC (Es-SCLC) - 1st Line (L1)durvalumab, etoposide plus either cisplatin or carboplatinetoposide plus either cisplatin or carboplatinadults with untreated extensive-stage small-cell lung cancer as First-line treatment268 / 269some concern
conclusif
  • demonstrated 27 % decrease in deaths (OS) (PE)
  • suggested 25 % decrease in deaths (OS) (extension)
  • suggested 20 % decrease in PFS (extension)
  • suggested 22 % decrease in progression or deaths (PFS)
durvalumab plus tremelimumab plus SoC
CASPIAN (DT ; all population), 2019
  NCT03043872
RCTExtensive stage SCLC (Es-SCLC) - 1st Line (L1)durvalumab plus tremelimumab and etoposide plus either cisplatin or carboplatinetoposide plus either cisplatin or carboplatinadults with untreated extensive-stage small-cell lung cancer (SCLC)268 / 269some concern
inconclusive
  • inconclusive 18 % decrease in deaths (OS) (PE)
versus placebo plus SoC
atezolizumab plus SoC
IMpower-133, 2018
  NCT02763579
RCTExtensive stage SCLC (Es-SCLC) - 1st Line (L1)atezolizumab (as induction and maintenance therapy) plus carboplatin and etoposideplacebo plus carboplatin and etoposidepatients with extensive-Stage Small-Cell Lung Cancer who had not received previous systemic treatment201 / 202low
conclusif
  • demonstrated 30 % decrease in deaths (OS) (PE)
  • demonstrated 23 % decrease in progression or deaths (PFS) (PE)
  • suggested 24 % decrease in deaths (OS) (extension)
  • suggested 23 % decrease in PFS (extension)
ipilimumab plus SoC
CA184-156, 2016
  NCT01450761
RCTExtensive stage SCLC (Es-SCLC) - 1st Line (L1)Ipilimumab plus etoposide plus platinePlacebo plus etoposide plus platinephased induction schedule followed by maintenance in patients with Extensive-Stage Small-Cell Lung Cancer (no prior systemic therapy for ED-SCLC)566 / 566high
inconclusive
  • inconclusive 6 % decrease in deaths (OS) (PE)
  • suggested 15 % decrease in progression or deaths (PFS)
pembrolizumab plus SoC
KEYNOTE-604, 2020
  NCT03066778
RCTExtensive stage SCLC (Es-SCLC) - 1st Line (L1)pembrolizumab plus etoposide plus platineplacebo plus etoposide plus platinepatients with newly diagnosed Extensive Stage Small Cell Lung Cancer228 / 225low
conclusif
  • suggested 20 % decrease in deaths (OS),deaths (OS) (PE)
  • demonstrated 25 % decrease in progression or deaths (PFS),progression or deaths (PFS) (PE)

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.