Table 2.
Ongoing trials plus immune checkpoint inhibitors in first-line setting and/or maintenance for extensive stage small-cell lung cancer
| Combination | Trial ID | Agent | Phase | N | Study design | Treatment | Endpoint | Status | Completion date |
|---|---|---|---|---|---|---|---|---|---|
| ICI + ChT | NCT02580994 (REACTION) | Pembrolizumab | II | 118 | Randomised, open-label, crossover of PE with/out pembrolizumab in patients with PR/CR after 2C of PE. | Arm A: PE + pembrolizumab × 4C → pembrolizumab Arm B: PE × 4C |
PFS | Recruiting | Aug 2020 |
| NCT03568097 (PAVE) | Avelumab | II | 55 | Open-label, single-arm study of phased avelumab plus PE | Arm A: PE + phased avelumab | 1 year PFS | Recruiting | Aug 2021 | |
| NCT04063163 | HLX10 (PD-1 inhibitor) | III | 489 | Randomised, double-blind, study of PE with/out HLX10 | Arm A: HLX10 + PE Arm B: placebo + PE |
PFS | Recruiting | Dec 2021 | |
| NCT03711305 | SHR-1316 (PDL-1 inhibitor) | III | 396 | Randomised, double-blind of PE with/out SHR-1316 | Arm A: SHR-1316 + PE × 4-6C → SHR-1316 Arm B: placebo + PE → placebo |
PFS and OS | Not yet recruiting | Dec 2022 | |
| NCT04012606 | Toripalimab (PDL-1 inhibitor) | III | 420 | Randomised, Double-blind of toripalimab with/out PE | Arm A: PE + toripalimab → toripalimab Arm B: PE + placebo → placebo |
PFS and OS | Recruiting | June 2022 | |
| NCT04005716 | Tislelizumab (PD-1 inhibitor) | III | 364 | Randomised, double-blind of PE with/out tislelizumab | Arm A: tislelizumab + PE × 4C → tislelizumab Control arm: placebo + PE × 4C → placebo |
PFS and OS | Recruiting | June 2022 | |
| NCT04221529 | Atezolizumab | II | 70 | Open-label, single-arm study of PE plus atezolizumab in PS 2 patients | Arm A: PE + atezolizumab → atezolizumab | OS | Recruiting | June 2024 | |
| ICI doublet + ChT | NCT03963414 | Durvalumab + tremelimumab | I | 18 | Open-label study of PE + durvalumab with/out tremelimumab in PS 2 patients | Arm A: durvalumab + tremelimumab + PE → durvalumab Arm B: durvalumab + PE → durvalumab |
Treatment-related adverse event > grade 3 | Not yet recruiting | July 2022 |
| ICI + ChT + other agent | NCT03041311 | Atezolizumab and Trilaciclib | II | 105 | Randomised study of PE and atezolizumab with/out trilaciclib | Arm A: PE plus atezolizumab + trilaciclib → atezolizumab Control arm: PE plus atezolizumab + placebo → atezolizumab |
Evaluate the potential of trilaciclib to reduce chemotherapy-induced myelosuppression | Active, not recruiting | May 2020 |
| NCT04256421(SKYSCRAPER-02) | Atezolizumab and tiragolumab (TIGIT inhibitor) | III | 400 | Randomised, double-blind study of atezolizumab plus PE with/out tiragolumab | Arm A: PE + atezolizumab plus trilaciclib → atezolizumab Control arm: PE + atezolizumab + placebo → atezolizumab |
PFS, OS | Recruiting | August 2023 | |
| NCT04101357 | Atezolizumab and BNT411 (TLR7 agonist) | I/II | 60 | Open-label, single-arm study of BNT411 plus atezolizumab plus PE (part 1B) | Arm A: PE + atezolizumab + BNT411 | DLT, AEs, dose reduction and discontinuation due to AEs | Not yet recruiting | Dec 2023 | |
| NCT02934503 | Pembrolizumab and RT | II | 60 | Open-label, single-group. of pembrolizumab and dynamic PD-L1 expression | Arm A: PE + pembrolizumab → pembrolizumab and RT Cohort B: PE + pembrolizumab → pembrolizumab Cohort C: PE → pembrolizumab Cohort D: PE + RT → pembrolizumab |
Change in PD-L1 expression status | Recruiting | Oct 2020 | |
| Maintenance | NCT03319940 | AMG 757 (BiTE targeting DLL3) ± pembrolizumab | I | 162 | Open-label study of AMG757 monotherapy or in combination with pembrolizumab in first-line/recurrent SCLC | Part A and C: AMG757 + pembrolizumab in recurrent SCLC Part B: AMG757 in patients with ongoing benefit after 6C of platinum ChT |
DLTs | Recruiting | Aug 2023 |
| NCT03410368 | NK Cell-based immunotherapy | II | 120 | A randomised, open-label study of NK cell-based immunotherapy as maintenance therapy after SD/PR/CR to PE | Arm A: three consecutive infusions of NK cells for a total of six courses | PFS | Recruiting | July 2020 | |
| NCT03958045 | Nivolumab + ricaparib | II | 36 | Open-label, single-group study of rucaparib plus nivolumab as maintenance therapy after PR/CR with PE | Arm A: nivolumab + ricaparib | PFS | Recruiting | July 2024 |
AEs, adverse cvent(s); BiTE, bispecific T cell engager; C, cycles; ChT, chemotherapy; CR, complete response; DLT, dose-limiting toxicity; DLL3, Delta-like protein 3; ICI, immune checkpoint inhibitor; NK, natural killer; OS, overall survival; PD-1/PDL-1, programmed death 1/programmed death-ligand 1; PE, platinum and etoposide; PFS, progression-free survival; PR, partial pesponse; PS, performance status; RT, radiotherapy; SCLC, small-cell lung cancer; SD, stable disease; TIGIT, T-cell immunoreceptors with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains.