Table 2. Ongoing trials of TKI adjuvant therapy.
| Trials | Registration number | Phase | Stage | Selected patients | N | NAd | Ad | Medication time | Primary endpoint | Secondary endpoint | Study start time | Estimated study completion date | Primary completion time | Reports about data |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| RADIANT | NCT00373425 | III | IB-IIIA | EGFR-positive by various tests (IHC and/or FISH) | 1,252 | None | Erlotinib* vs. placebo* | 2 years | DFS | OS; DFS and OS in EGFR mutation+; AEs | 2006.9 | 2016.6 | 2013.4 | 2009 ASCO7520; 2014 ASCO7501, 7513 |
| SELECT | NCT00567359 | II | IA-IIIA | NSCLC; complete resection; EGFR mutation+; PS 0-2 | 100 | Erlotinib (single arm) | None | 28 days before surgeries | 2-year DFS | Safety, OS | 2006.5 | 2015.6 | 2014.5 | 2010 ASCO 7078; 2012 ASCO7010; 2014 ASCO7514 |
| WJOG6410L | III | II-III | 19, L858R mutation+; without T790M mutation | 230 | None | Gefitinib 250 mg/day vs. NVB + DDP | 2 years vs. 4 cycles | DFS | OS, safety, patterns of recurrence | 2011.9 | 3 years of enrolment and 5 years of following up | 2012 ASCO TPS7110 | ||
| ADJUVANT | NCT01405079 | III | II-IIIA (N1-N2) | Completely resected pathological NSCLC with EGFR exon 19 deletions and exon 21 L858R activating mutation; PS 0-1 | 220 | None | Gefitinib vs. NVB + Cis | 2 years vs. 4 cycles | DFS | OS, 3-year DFS, 5-year DFS/OS, safety, QoL, AE | 2011.7 | 2018.8 | 2016.8 | |
| ML28280 | NCT01683175 | II | IIIA | 19, L858R mutation+ | 94 | None | Erlotinib vs. NVB + Cis | 2 years vs. 4 cycles | 2-year DFS | DFS, OS, safety, QoL, AE, SAE | 2012.8 | 2019.3 | 2019.3 |
*, six months from the day of surgery for patients who underwent chemotherapy, 3 months from the day of surgery for those who did not undergo chemotherapy. NAd, neoadjuvant therapy; Ad, adjuvant therapy; EGFR, epidermal growth factor receptor; IHC, immunohistochemistry; FISH, fluorescence in situ hybridization; DFS, disease-free survival; OS, overall survival; AE, adverse events; ASCO, American Society of Clinical Oncology; NSCLC, non-small cell lung cancer; PS, performance status; NVB, vinorelbine; DDP, diamminedichloroplatinum; Cis, cisplatin; QoL, quality of life; SAE, serious adverse events.