Table 2.
Ongoing phase II–III neoadjuvant and adjuvant trials with tyrosine kinase inhibitors (TKIs).
| Trial | Phase | Design | Population | Arm(s) | Primary Outcome | Clinical Trial Identification |
|---|---|---|---|---|---|---|
| ALCHEMIST | III | adjuvant | IB-IIIA NSCLCs, EGFR-mutated NSCLC | erlotinib for 2 years vs. placebo |
OS | NCT02194738 |
| ALCHEMIST | III | adjuvant | IB-IIIA NSCLCs, ALK-rearranged NSCLC | crizotinib for 2 years vs. placebo |
OS | NCT02194738 |
| ALINA | III | adjuvant | IB-IIIA NSCLCs, ALK-rearranged NSCLC | alectinib for 2 years vs. chemotherapy |
DFS | NCT03456076 |
| EMERGING | II | Neoadjuvant + adjuvant | IIIA EGFR-mutated NSCLCs | erlotinib for 6 weeks then 1 year post-op vs. cisplatin-gemcitabine |
ORR | NCT01407822 |
| NCT03203590 | III | neoadjuvant | II-IIIA EGFR-mutated NSCLC | gefinitib for 8 weeks vs. carboplatin-vinorelbine |
2 year DFS | NCT03203590 |
| NeoADAURA | III | neoadjuvant | II-IIIA EGFR-mutated NSCLC | osimertinib +/− platinum-pemetrexed vs. platinum-pemetrexed |
MPR | NCT04351555 |
| NCT04302025 | II | Neoadjuvant +/− adjuvant | IB-IIIB NSCLC with altered ALK, ROS1, NTRK or BRAF |
8 weeks neoadjuvant +/− adjuvant with alectinib, entrectinib or vemurafenib+cobimetinib |
MPR | NCT04302025 |
| NCT03088930 | II | neoadjuvant | IA-IIIA NSCLC with altered MET, ROS1 or ALK |
crizotinib for 6 weeks | ORR | NCT03088930 |
Abbreviations: DFS, disease-free survival; OS, overall survival; MPR, major pathological response; ORR, objective response rate.