Table 2.
Ongoing clinical trials with ICIs in the front-line setting in elderly patients
| Trial ID | Study phase | Treatment arms | PD-L1 | Age setting (years) | Primary endpoint |
|---|---|---|---|---|---|
| NCT04396457 | II | Pembrolizumab plus pemetrexed | <50% | ≥75 | ORR |
| NCT03975114 (MILES-5) | II | CTx → at PD: durvalumab or Durvalumab → at PD: CTx or Durvalumab plus tremelimumab → at PD: CTx | Any | ≥70 | 12 months OS |
| NCT03293680 | II | Pembrolizumab | ≥1% | ≥70 | 12 months OS |
| NCT05273814 | I | Tislelizumab plus bevacizumab and pemetrexed | Any | ≥65 | ORR |
| NCT04533451 | II | Pembrolizumab or Pembrolizumab plus carboplatin plus pemetrexed | Any | ≥70 | AEs |
| NCT03977194 | III | Carboplatin plus paclitaxel or Carboplatin plus paclitaxel plus atezolizumab | Any | ≥70-89 | OS |
| NCT05230888 | Prospective | CGA and VES-13 questionnaire in patients receiving ICIs | Any | ≥70 | irAEs |
AEs, adverse events; CGA, comprehensive geriatric assessment; CTx, chemotherapy; ICIs, immune checkpoint inhibitors; irAEs, immune-related adverse events; ORR, overall response rate; OS, overall survival; PD, progressive disease; PD-L1, programmed cell death-ligand 1; VES, Vulnerable Elders Survey.