Table 4.
Representative clinical trials investigating the combination of PD-1/PD-L1 and CTLA-4 blockade immunotherapies in NSCLC.
| Clinical trial # | PD-1/PD-L1 inhibitor | CTLA-4 inhibitor | Key findings | Reference |
|---|---|---|---|---|
|
NCT02000947 (Phase Ib) |
MEDI4736 (anti-PD-L1 mAb) | Tremelimumab | - Advanced NSCLC patients - ORR, 23% - Grade 3-4 AEs, 35% |
(138) |
|
NCT01454102 (Phase I) |
Nivolumab | Ipilimumab | - Untreated advanced NSCLC - ORR, 47% - Median PFS, 8.1 months - 24-week PFS rate, 68% - Grade 3-4 AEs, 37% |
(139) |
| NCT02659059 (Phase II) | Nivolumab | Ipilimumab | - Untreated advanced (Stage IV) NSCLC patients - In patients with TMB > 10 mutations/megabase: ORR, 44% Median PFS, 7.1 months 6-month PFS rate, 55% Grade 3-4 AEs, 29% |
(140) |
|
NCT02477826 (Phase III) |
Nivolumab | Ipilimumab | - Untreated advanced (Stage IV) NSCLC patients - In patients with TMB > 10 mutations/megabase: ORR, 45% Median PFS, 7.2 months 12-month PFS rate, 43% HR for disease progression or death, 0.58 Grade 3-4 AEs, 31% |
(139) |
AE, adverse event; HR, hazard ratio; mAb, monoclonal antibody; ORR, objective response rate; PFS, progression free survival; TMB, tumor mutational burden.