Table 2.
Select ongoing trials with immunotherapy plus thoracic radiation therapy in ES-SCLC.
| Trial | Phase | TRT Setting | Interventions | thoracic radiotherapy(TRT) | N | Primary end point |
|---|---|---|---|---|---|---|
|
NCT04402788
(RAPTOR/NRG-LU007) |
Phase 2/3 | Maintenance after atezolizumab + chemotherapy | atezolizumab vs. atezolizumab+ TRT | QD on days 1-5 during weeks 1-5 only | 138 | PFS and OS |
|
NCT04462276
(TREASURE) |
Phase 2 | Maintenance after atezolizumab + chemotherapy | atezolizumab vs. atezolizumab+ TRT | 30 Gy in 10 fractions | 104 | OS |
| NCT03923270 | Phase 1 | Maintenance after Chemotherapy | TRT + Durvalumab vs. TRT+ Durvalumab + Tremelimumab vs. TRT+ Durvalumab +Olaparib | 30 Gy in 10 fractions | 25 | Unacceptable SAEs; PFS(Phase IB) |
|
NCT04314297
(AVATAR 2) |
Phase 2 | Maintenance after Chemotherapy | Anlotinib+ Durvalumab at the end of TRT | NA | 33 | PFS |
|
NCT04472949
(SAKK 15/19) |
Phase 2 | Maintenance after EC+ Durvalumab | TRT + Durvalumab | 39 Gy in 13 fractions | 46 | PFS |
|
NCT04728230
(PRIO) |
Phase 1/2 | Maintenance | Chemotherapy + Durvalumab+ Olaparib+ TRT | NA | 63 | AEs |
| NCT04562337 | Phase 2 | Maintenance | SHR1316+Chemotherapy →TRT+ SHR1316 | NA | 67 | OS |
|
NCT05161533
(CASPIAN-RT) |
Phase 2 | Maintenance | EC/EP+ durvalumab × 4 cycles→durvalumab + hypofractionated TRT | Hypofractionated TRT beginning cycle 5 or 6 of durvalumab | 50 | PFS |
| NCT05403723 | Phase 1 | First-line induction therapy* | SBRT+ durvalumab+EC →durvalumab maintenance | 30Gy in 5 fractions or 27 Gy in 3 fractions to the primary tumor site between cycle 2 and cycle 3 | 50 | AEs |
| NCT05092412 | Phase 2 | First-line induction therapy | Low-dose TRT + durvalumab + EP/EC | 15 Gy in 5fractions starting from Day 1 in the first cycle | 30 | PFS |
|
NCT05223647
(TRIPLEX) |
Phase 3 | First-line induction therap | Chemo-immunotherapy + TRT vs. Chemo-immunotherapy | 30 Gy in10 fractions between 2nd and 3rd cycle | 302 | Change in 1-year OS |
| NCT04951115 | Phase 2 | First-line induction therap | SBRT+ Chemo-Immunotherapy | 6 Gy of radiotherapy targeting multiple sites of intrathoracic disease on Days 1-5 of cycle 1 | 42 | AEs and PFS |
|
NCT04622228
(Match) |
Phase 2 | First-line induction therap | LDRT+ EC/EP + atezolizumab | 15 Gy in 5 fractions from Day 1- 5 in the first cycle | 55 | ORR |
TRT, thoracic radiotherapy; LDRT, low-dose radiotherapy; SBRT, stereotactic body radiotherapy.
*Patients with SD or PD completed two cycles of durvalumab+EC.