Summary of phase III trials in the neoadjuvant, perioperative, and adjuvant settings that led to FDA approval
Trial (NCT#)
Stage (AJCC); patient traits
Regimen
Primary endpoint results
FDA approval indication
IMpower010 (NCT02486718)
IB (≥ 4 cm)–IIIA (7th)
Adjuvant chemo followed by atezolizumab every 3 weeks for up to 16 cycles
DFS in stage II–IIIA (PD-L1 ≥ 1%), all stage II–IIIA and ITT populations:HR 0.66 (P = 0.0039); 0.79 (P = 0·020) and 0.81 (P = 0.040)
Adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test
KEYNOTE 091/PEARLS (NCT02504372)
IB (≥ 4 cm)–IIIA (7th)
Adjuvant chemo followed by pembrolizumab every 3 weeks for up to 18 cycles
DFS in all population and PD-L1 TPS ≥ 50%:HR 0.76, P = 0.0014 and HR 0.82, P = 0.14
Adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥ 4 cm), II, or IIIA disease
CheckMate 816 (NCT02998528)
IB (≥ 4 cm)–IIIA (7th); irrespective of PD-L1
Neoadjuvant nivolumab plus chemo every 3 weeks for 3 cycles
EFS:HR 0.63, P = 0.005pCR: 24.0% vs. 2.2%Odds ratio 13.9, P < 0.001
Resectable disease (tumors ≥ 4 cm or node positive); in combination with platinum-doublet chemotherapy in the neoadjuvant setting
KEYNOTE 671 (NCT03425643)
II–IIIB (N2 stage) (8th)
Pembrolizumab plus chemo × 4 cycles; surgery; adjuvant pembrolizumab every 3 weeks for up to 13 cycles
EFS:HR 0.58, P < 0.00001OS:HR 0.72, P = 0.00517
Resectable disease (tumors ≥ 4 cm or node positive); in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery
AEGEAN (NCT03800134)
IIA to stage IIIB (N2 stage) (8th)
Durvalumab plus chemo × 4 cycles; surgery; adjuvant durvalumab every 4 weeks for up to 12 cycles
EFS:HR 0.68, P = 0.0004pCR:17.2% vs. 4.3%, P < 0.001
Resectable (tumors ≥ 4 cm and/or node positive) with no known EGFR or ALK alterations; in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery
CheckMate 77T (NCT04025879)
IIA to stage IIIB (single- or multistation N2) (8th)
Nivolumab plus chemo × 4 cycles; surgery; adjuvant nivolumab every 4 weeks for one year
EFS:HR 0.58, P < 0.001pCR: 25.3% vs. 4.7%Odds ratio, 6.64; 95% CI, 3.40 to 12.97Major pathological response: 35.4% vs. 12.1%Odds ratio, 4.01; 95% CI, 2.48 to 6.49
Resectable (tumors ≥ 4 cm and/or node positive) with no known EGFR or ALK alterations; in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery
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