Table 4.
Ongoing clinical trials of radiotherapy and immune checkpoint inhibitor combination in locally advanced stage non-small cell lung cancer in the concomitant setting
|
Ref.
|
Phase
|
Design
|
No.of patients
|
Tumor stage
|
RT
|
ICI agent
|
Sequence
|
Status
|
| ARCHON-1, NCT03801902[85] | 1; 2 RT arms | ICI + RT | 24 | Unresectable II-III | Conventional RT (60 Gy/30 fx); Hypofractionated RT (60 Gy/15 fx) | Durvalumab | Concomitant with definitive RT | Recruiting |
| PARTICLE-D, NCT03818776[86] | 1; 2 RT arms (proton beam therapy | ICI + RT | 27 | Unresectable III | RT 60 Gy/20 fx; RT 63 Gy/23 fx | Durvalumab | Concomitant with definitive RT | Recruiting |
| NCT04013542[87] | 1 | ICI + RT | 20 | II-III | Conventional RT | Ipilimumab + Nivolumab | Concomitant with definitive RT and consolidation (nivolumab) | Recruiting |
| NCT03663166[88] | 1; 2 | Concomitant CRT + ICI +/- consolidative ICI | 50 | Unresectable III | 60 Gy/30 fx | Ipilimumab +/-Nivolumab | Concomitant definitive treatment +/- consolidative ICI | Recruiting |
| SPRINT,NCT03523702[54] | 2 | ICI + RT (if PD-L1 ≥ 50%) ; CRT (if PD-L1 < 50%) | 63 | Unresectable III | Conventional RT | Pembrolizumab | Concomitant with definitive RT | Recruiting |
| KEYNOTE-799, NCT03631784[89] | 2 | Concomitant ICI + CRT (platinum doublet) followed by ICI | 216 | Unresectable III | 60 Gy/30 fx | Pembrolizumab | Concomitante and consolidative | Active, not recruiting |
| NCT04092283[90] | 3 randomized | Concomitant CRT + ICI vs CRT followed by ICI (CT: Cisplatin + VP16/ Taxol + Carboplatin/ Cisplatin + Pemetrexed) | 660 | Unresectable III | 60 Gy/30 fx | Durvalumab | Concomitant with definitive treatment vs adjuvant ICI | Recruiting |
| PACIFIC 2, NCT03519971[91] | 3 randomized, double-blinded | ICI vs placebo concomitant to CRT (CDDP-VP16 vs Carbo-Taxol vs Cisplatin or Carbo + Pemetrexed) | 328 | Unresectable III | Conventional RT (60 Gy in 30 fx) | Durvalumab | Concomitant +/- consolidative | Active, not recruiting |
| NCT04026412[92] | 3 randomized | ICI (nivolumab) + CRT followed by ICI (nivolumab + ipilimumab) vs ICI (nivolumab) + CRT followed by ICI (nivolumab) vs CRT followed by durvalumab | 1400 | Unresectable/inoperable III | Conventional RT | Nivolumab; Ipilimumab; Durvalumab | Concomitant + 2 consolidation regimens vs consolidation after CRT | Recruiting |
RT: Radiotherapy; CRT: Chemoradiotherapy; CT: Chemotherapy; ICI: Immune checkpoint inhibitor; Gy: Gray.