TABLE 8

Planned/ongoing phase III randomised controlled trials comparing adjuvant EGFR-TKI to placebo after complete resection in EGFR mutant (exon 19 deletion/exon 21 L858R) NSCLC patients

ADJUVANT (NCT 01405079)International ADAURA trial (NCT 02511106)Korean trial (NCT 02795884)Japanese WJOG6410L trialChinese EVIDENCE trial (NCT02448797)Chinese ICTAN trial (NCT 01996098)ICWIP (NCT 02125240)
Experimental armGefitinib 250 mg once daily, 24 monthsOsimertinib 80/40 mg once dailyIntercalated: erlotinib 150 mg once daily days 8–21, pemetrexed/cisplatin day 1, four cycles every three weeks; maintenance: erlotinib 150 mg once daily 1 yearGefitinib 250 mg once daily, 24 monthsIcotinib 125 mg three times daily until PDArm A: icotinib 125 mg three times daily, 6 months; arm B: icotinib 125 mg three times daily, 12 monthsIcotinib 125 mg three times daily until PD
Comparator armNP four cycles every three weeksPlacebo once dailyNP four cycles every three weeksNP four cycles every three weeksNP four cycles every 3 weeksPlatinum-based chemotherapy four cyclesPlacebo three times daily until PD
EligibilityStage IIA–IIIAStage IB–IIIA, predominantly non-squamous cell carcinoma, with/without adjuvant chemotherapyStage IB–IIIA non-squamous cell carcinomaStage II–IIIStage II–IIIA adenocarcinoma, no right pneumonectomyStage IIA–IIIAStage II–IIIA adenocarcinoma, adjuvant four cycles cisplatin-based chemotherapy
Primary end-pointDFSDFSDFSDFSDFSDFSDFS
Secondary end-pointsOS, 3-year DFS, 5-year DFS and OS, AEs, QoL2, 3 and 5-year DFS, OS, HRQoL, pharmacokineticsOS, AEsOS, AEs, type of recurrenceOSOS, AEs, QoLOS, AEs, HRQoL
Target recruitment220 patients700 patients227 patients230 patients320 patients477 patients300 patients
  • EGFR: epidermal growth factor receptor; TKI: tyrosine kinase inhibitor; PD: progressive disease; NP; cisplatin, vinorelbine; DFS: disease-free survival; OS: overall survival; AEs: adverse events; QoL: quality of life; HRQoL: health-related quality of life.