Table 1.
Summary of the primary endpoints in published phase III neoadjuvant and perioperative clinical trials in stages I–III non-small cell lung cancer.
| Trial/NCT identifier | Stage | No. of patients (%) | Event-free survival (median in months, 95% CI) |
Hazard ratio (95% CI) | Co-primary endpoint | |
|---|---|---|---|---|---|---|
| Experimental arm | Control arm | |||||
| CheckMate 8162,20 NCT02998528 |
All stagesa IB-II IIIA |
358 (100) 126 (35) 229 (64) |
NR (31.6–NR) NRb NRb |
21.1 (14.8–42.1) NRb 16.9b |
0.68 (0.49–0.93) 0.94b,c 0.57b,c |
pCR: CT + nivolumab 24.0% (43/179) vs CT 2.2% (4/179) |
| CheckMate 77T5 NCT04025879 |
All stagesd II III |
461 (100) 162 (35) 297 (64) |
NR (28.9–NR) NR (22.6–NR) 30.2 (26.9–NR) |
18.4 (13.6–28.1) NR (24.4–NR) 13.4 (9.8–17.7) |
0.58 (0.42–0.81) 0.81c (0.46–1.43) 0.51c (0.36–0.72) |
None |
| AEGEAN4 NCT03800134 |
All stagesd II IIIA IIIB |
740 (100) 214 (29) 338 (46) 186 (25) |
NR (31.9–NR) NR (NR–NR) NR (NR–NR) 31.9 (11.7–NR) |
25.9 (18.9–NR) 31.1 (25.4–NR) 19.5 (11.7–NR) 18.9 (11.8–NR) |
0.68 (0.53–0.88) 0.76c (0.43–1.34) 0.57c (0.39–0.83) 0.83c (0.52–1.32) |
pCR: CT + durvalumab 17.2% (63/366) vs CT + placebo 4.3% (16/374) |
| KEYNOTE-67121 NCT03425643 |
All stagesd II IIIA IIIB |
797 (100) 239 (30) 441 (55) 117 (15) |
47.2 (32.9–NR) Not reported Not reported Not reported |
18.3 (14.8–22.1) Not reported Not reported Not reported |
0.59 (0.48–0.72) 0.59c (0.40–0.88) 0.57c (0.44–0.74) 0.57c (0.36–0.90) |
OSe (stage II–IIIB): CT + pembrolizumab NR (NR–NR) vs CT + placebo 52.4 (45.7–NR) HR 0.72 (95% CI 0.56–0.93) |
| Neotorch6 NCT04158440 |
All stagesd, f IIIA IIIB |
404 (100) 272 (67) 129 (32) |
NR (24.4–NR) Not reported Not reported |
15.1 (10.6–21.9) Not reported Not reported |
0.40 (0.28–0.57) 0.44c (0.29–0.66) 0.30c (0.15–0.56) |
MPR: CT + toripalimab 48.5% (98/202) vs CT + placebo 8.4% (17/202) |
Abbreviations: NCT, national clinical trial; CI, confidence interval; NR, not reached; pCR, pathological complete response; CT, chemotherapy; OS, overall survival; HR, hazard ratio; MPR, major pathological response.
Median follow-up (months): CheckMate 816, 41.4 m; CheckMate 77T, 25.4 m; AEGEAN, 11.7 m (among patients without an event); KEYNOTE-671, 36.6 m; Neotorch, 18.3 m. The number of patients in the substages may not add up to 100%.
American Joint Committee on Cancer (AJCC) seventh edition.
95% CI not reported.
Unstratified hazard ratio.
AJCC eighth edition.
Median in months with 95% CI.
Based on the first interim analysis of stage III patients.