Review Article

The Role of Immunotherapy in Extensive Stage Small-Cell Lung Cancer: A Review of the Literature

Table 1

Selected clinical trial of immunotherapy agents for SCLC.

TrialPhaseLineStudy typeTherapyPrimary endpointResultsClinTrial Gov Identifier

Checkmate 032 [19]I/II3rdRandomized cohortNivolumab ± ipilimumabORRNivo 3 mg/kg ORR: 12%NCT01928394
Nivo 1 mg/kg + ipi 3 mg/kg ORR: 23%
Nivo 3 mg/kg + ipi 1 mg/kg ORR: 19%

IMpower 133 [21]III1stRandomized, multicenter double-blind, placebo-controlledCarboplatin + etoposide + atezolizumab or carboplatin + etoposide + placeboPFS + OSMedian OS: 12.3 months vs 10.3 monthsNCT02763579
Median PFS: 5.2 months vs 4.3 months

Checkmate 331 [22]III2ndRandomized, open label, globalNivolumab vs topotecan/amrubicinOSPrimary endpoint not metNCT02481830

Checkmate 451 [23]III1st (main)Randomized, double-blind, multicenterNivolumab, nivolumab + ipilimumab, placeboOSPrimary endpoint not metNCT02538666

Keynote 028 [24]Ib2ndOpen label, nonrandomized, multicenter, multicohortPembrolizumabBest OR (RECIST version 1.1)ORR: 33%NCT02054806

Keynote 158 [25]II2ndOpen label, nonrandomized, multicenter, multicohortPembrolizumabORRORR: 19%NCT02628067

Keynote 604 [27]III1stRandomized, double-blind, placebo-controlledPembrolizumab + platinum/etoposide vs platinum/etoposidePFS + OSOngoingNCT03066778

Caspian [28]III1stRandomized, multicenter, open labelDurvalumab ± tremelimumab + chemotherapy vs chemotherapyPFS + OSOngoingNCT03043872

Meru [29]III2ndRandomized, double-blind, placebo-controlledRova-T + dexamethasone vs placebo (after chemo)PFS + OSOngoingNCT03033511