Table 5.
Ongoing clinical trials involving radiotherapy and immunotherapy in stage IV non-small cell lung cancer
|
Ref.
|
Phase
|
ICI agent
|
RT dose
|
Design
|
Primary endpoints
|
| NCT03158883[93] | I | Avelumab | 50 Gy/5 fx | ICI + SABR | ORR |
| NCT03224871[94] | I | Nivolumab; Pembrolizumab; Intratumor IL-2 | 8 Gy/3 fx | ICI + IL-2 + RT | MTD |
| NCT03436056, PRIMING[95] | I | Pembrolizumab | SABR 30 Gy-3 fx SABR 54 Gy/3 fx | ICI + SABR | MTD |
| NCT03812549[96] | I | Sintilimab | SABR 30 Gy/3 fx; LD (low dose)-RT: 2 Gy/1 fx or 4 Gy/2 fx or 10 Gy/5 fx | ICI + SABR; ICI + LD-RT | MTD |
| NCT03223155, COSINR[69] | I | Nivolumab; Ipilimumab | SABR 3-5 fx, 2-4 sites | ICI + SABR | MTD |
| NCT02639026[97] | I | Durvalumab; Tremelimumab | HFRT 24 Gy/3 fx, 17 Gy/1 fx | ICI + HFRT | MTD |
| NCT03275597[98] | I | Durvalumab; Tremelimumab | SABR 30-50 Gy/5 fx | ICI + SABR | MTD |
| NCT03168464[99] | I-II | Nivolumab; Ipilimumab | RT 30 Gy/5 fx | ICI + RT | ORR |
| NCT02239900[100] | I-IIR | Ipilimumab | SABR 50 Gy/4 fx or 60 Gy/10 fx; 1-4 lesions | ICI + SABR | MTD |
| NCT02444741[101] | I-IIR | Pembrolizumab | SABR 4 fx or IMRT, PBRT, 3D-CRT 15 fx | ICI + SABR or IMRT, PBRT, 3D-CRT | MTD, ORR |
| NCT03176173, RRADICAL[102] | II | Nivolumab; Pembrolizumab; Atezolizumab | SABR 1-10 fx | ICI +/- SABR | PFS |
| NCT03965468, CHESS[103] | II | Durvalumab | SABR 1-10 fx | ICI + SABR + CT | PFS |
| NCT03044626, FORCE[104] | II | Nivolumab | RT 20 Gy/5 fx | ICI + RT | ORR |
| NCT02221739[105] | II | Ipilimumab | IMRT or 3D-CRT 30 Gy/5 fx | ICI + RT | ORR |
| NCT02658097[106] | II | Pembrolizumab | RT 8 Gy/1 fx | ICI + RT | ORR |
| NCT03391869, LONESTAR[107] | III | Nivolumab; Ipilimumab | LCT | ICI +/- SABR | OS |
| NCT03867175[108] | III | Pembrolizumab | SABR 3-10 fx | ICI +/- SABR | PFS |
| NCT03774732, NIRVANA-LUNG[109] | III | Pembrolizumab | SABR or 3D-CRT 18 Gy/3 fx | ICI + RT + CT | OS |
ICI: Immune checkpoint inhibitors; Fx: Fraction; SABR: Stereotactic ablative radiotherapy; RT: Radiotherapy; LD-RT: Low dose radiotherapy; HFRT: Hypofractionated radiotherapy; IMRT: Intensity modulated radiotherapy; PBRT: Proton beam radiation therapy; 3D-CRT: 3D conformal radiation therapy; LCT: Local consolidation therapy; CT: Chemotherapy; ORR: Overall response rate; MTD: Maximum tolerated dose.