Experimental arm | Gefitinib 250 mg once daily, 24 months | Osimertinib 80/40 mg once daily | Intercalated: erlotinib 150 mg once daily days 8–21, pemetrexed/cisplatin day 1, four cycles every three weeks; maintenance: erlotinib 150 mg once daily 1 year | Gefitinib 250 mg once daily, 24 months | Icotinib 125 mg three times daily until PD | Arm A: icotinib 125 mg three times daily, 6 months; arm B: icotinib 125 mg three times daily, 12 months | Icotinib 125 mg three times daily until PD |
Comparator arm | NP four cycles every three weeks | Placebo once daily | NP four cycles every three weeks | NP four cycles every three weeks | NP four cycles every 3 weeks | Platinum-based chemotherapy four cycles | Placebo three times daily until PD |
Eligibility | Stage IIA–IIIA | Stage IB–IIIA, predominantly non-squamous cell carcinoma, with/without adjuvant chemotherapy | Stage IB–IIIA non-squamous cell carcinoma | Stage II–III | Stage II–IIIA adenocarcinoma, no right pneumonectomy | Stage IIA–IIIA | Stage II–IIIA adenocarcinoma, adjuvant four cycles cisplatin-based chemotherapy |
Primary end-point | DFS | DFS | DFS | DFS | DFS | DFS | DFS |
Secondary end-points | OS, 3-year DFS, 5-year DFS and OS, AEs, QoL | 2, 3 and 5-year DFS, OS, HRQoL, pharmacokinetics | OS, AEs | OS, AEs, type of recurrence | OS | OS, AEs, QoL | OS, AEs, HRQoL |
Target recruitment | 220 patients | 700 patients | 227 patients | 230 patients | 320 patients | 477 patients | 300 patients |