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. 2021 Oct 7;10(10):2685. doi: 10.3390/cells10102685

Table 1.

Main neoadjuvant and adjuvant clinical trials testing EGFR TKIs in NSCLC.

Trial Ph Stage Study Arm(s) N Primary Endpoint Main Results Safety
(AEs Grade 3–4)
Neoadjuvant
EMERGING CTONG 1103 [15,20] II IIIA–N2 Erlotinib
ChT		 37 (E)
35 (ChT)		 ORR
  • -

    ORR: 54% (E) vs. 34% (ChT)

  • -

    (OR 2.26, 95% CI 0.87–5.84, p = 0.092)

  • -

    mOS: 42.2 mo (E) vs. 36.9 mo (ChT)

  • -

    (HR 0.83, 95%CI 0.47–1.47, p = 0.513)

 0 (E)
29.4% (ChT)
NCT01217619# [16] II IIIA Erlotinib
ChT		 15 (E)
16 (ChT)		 Radical resection rate
  • -

    ORR: 67% (E) vs. 19% (ChT) (NS)

  • -

    mDFS: 10.2 mo (E) vs. 8.0 mo (ChT) (p = 0.25)

  • -

    mOS: 51.0 mo (E) vs. 20.9 mo (ChT) (p = 0.12)

 NA
NCT00600587 * [17] II IIIA–N2 Erlotinib
ChT		 12 (E)
12 (ChT)		 ORR
  • -

    ORR: 58.3% (E) vs. 25.0% (ChT) (p = 0.18)

  • -

    mPFS: 6.9 mo (E) vs. 9.0 mo (ChT) (p = 0.071)

  • -

    mOS: 14.5 mo (E) vs. 28.1 mo (ChT) (p = 0.2)

 16.7% (skin rash) (E)
No better specified
Rizvi NA, et al. [18] II I–II Gefitinib 50 Correlation of radiographic response with EGFR mut
  • -

    ORR: 17/21 with an EGFR mutation and 4/21 without (p = 0.0001)

 1/50 (diarrhea) (G)
NCT01833572 [19] II II–IIIA Gefitinib 33 ORR
  • -

    ORR: 54.5%

  • -

    mDFS: 33.5 mo

 0
Adjuvant
BR.19 ‡ [21] III IB–IIIA
15 EGFR mutant 		Gefitinib (2 y) Placebo (2 y) 251 (G)
252 (p)		 OS
DFS
  • -

    DFS: 4.2 y (G) vs. NR (p)

  • -

    (HR 1.22, 95% CI 0.93–1.61; p = 0.15)

  • -

    OS : 5.1 y (G) vs. NR (p)

  • -

    (HR 1.24, 95% CI 0.94–1.64; p = 0.14)

 5–8% (mainly rash, diarrhea, dyspnea) (G)
RADIANT [22] III IB–IIIA
EGFR pos
(IHC/FISH)		 Erlotinib (2 y) Placebo (2 y) 623 (E)
350 (p)		 DFS
  • -

    DFS: 50.5 mo (E) vs. 48.2 mo (p)

  • -

    (HR 0.90, 95% CI 0.74–1.10; p = 0.324)

  • -

    DFS in EGFR mut: 46.4 (E) vs. 28.5 (p)

  • -

    (HR 0.61, 95% CI 0.38–0.98; p = 0.0391)

 22.3% (rash) (E)
6.2% (diarrhea) (E)
SELECT [23] II I–IIIA Erlotinib (2 y) 100 2 y DFS
  • -

    2 y DFS: 88%

  • -

    (vs.historical control 76%; p = 0.0047)

 13% (rash) (E)
3% (diarrhea) (E)
CTONG1104/
ADJUVANT [24,25]		 III II–IIIA Gefitinib (2 y)
ChT (4 cycles)		 222 DFS
  • -

    DFS: 28.7 mo (G) vs. 18 mo (ChT)

  • -

    (HR 0.60, 95% CI 0.42–0.87; p = 0.0054)

  • -

    mOS : 75.5 mo (G) vs. 79.2 mo (ChT)

  • -

    (HR 0.96, 95%CI 0.64–1.43; p = 0.823)

 12% (G)
48% (ChT)
EVAN [26] II IIIA Erlotinib (2 y)
ChT (4 cycles)		 51 (E)
51 (ChT)		 2 y DFS
  • -

    2 y DFS: 81.4% (E) vs. 44.6% (ChT)

  • -

    (RR 1.823, 95% CI 1.194–2.784; p = 0.0054)

  • -

    DFS: 42.4 mo (E) vs. 21 (ChT)

  • -

    (HR 0.268, 95% CI 0.136–0.531; p < 0.0001)

 12% (E)
26% (ChT)
Li et al. [27] II IIIA N2 ChT (4 cycles) +/− Gefitinib (6 mo) 30 (ChT-G)
30 (ChT)		 DFS
  • -

    DFS: 39.8 mo (ChT-G) vs. 27 mo (ChT)

  • -

    (HR 0.37, 95% CI 0.16–0.85; p = 0.014)

  • -

    2 y OS: 92.4% (ChT-G) vs. 77.4% (ChT)

  • -

    (HR 0.37, 95% CI 0.12–1.11; p = 0.076)

 20% (ChT-G)
16.7% (ChT)
ADAURA [11] III IB–IIIA Osimertinib (3 y)
Placebo (3 y)		 339 (O)
343 (p)		 DFS
  • -

    DFS: NR (O) vs. 20.4 mo (p)

  • -

    (HR 0.17, 99.06% CI 0.11–0.26; p < 0.001)

  • -

    DFSrate: 89% (O) vs. 52% (p)

  • -

    (HR 0.20, 99.12% CI 0.14–0.30; p < 0.001)

 20% (diarrhea, stomatitis) (O)
IMPACT [28] III II–IIIA Gefitinib (2 y)
ChT (4 cycles)		 116 (G)
116 (ChT)		 5 y DFS
  • -

    DFS: 35.9 mo (G) vs. 25.0 mo (ChT)

  • -

    (HR 0.92, 95% CI 0.67–1.28; p = 0.63)

  • -

    5 y survival rates: 78.0% (G) vs. 74.6% (ChT) (HR 1.03, 95% CI 0.65–1.65; p = 0.89)

 NA

Legend: N, number; AEs, adverse events; ChT, chemotherapy; ORR, overall response rate; E, erlotinib; G, gefitinib; mOS, median overall survival; mo, months; DFS, disease-free survival; ChTRT, chemoradiotherapy; MPR, major pathological response; mPFS, median progression-free survival; y, years; NR, not reached; O, osimertinib; RR, relative risk; NA, not available; NS, not statistically significant. # Previously published as a single-arm study (Xiong L., et al. Oncologist 2019; 24: 157-e64) * Treatment assignment based on EGFR mutation status ‡ Early closure for safety concerns.