Table 5. Ongoing trials of neoadjuvant and adjuvant therapy with tyrosine kinase inhibitors.
Trial | Phase | Therapy | Population | Arms | Primary endpoint |
---|---|---|---|---|---|
EMERGING | II | Neoadjuvant | IIIA EGFR+ | Erlotinib for 6 weeks, then 1 year postoperatively cisplatin/gemcitabine | ORR |
NCT03203590 | II | Neoadjuvant | II–IIIA EGFR+ | Gefitinib for 8 weeks carboplatin/vinorelbine | 2-year DFS |
NeoADAURA | II | Neoadjuvant | II–IIIA EGFR+ | Osimertinib ± platinum/pemetrexed platinum/pemetrexed | MPR |
ALCHEMIST-ALK | III | Adjuvant | IB–IIIA ALK+ | Crizotinib for 2 years placebo | OS |
ALINA | III | Adjuvant | IB–IIIA ALK+ | Alectinib for 2 years chemotherapy | DFS |
NCT04302025 | II | Neoadjuvant | IB–IIIB ALK+, ROS1+, NTRK+, BRAF+ | Neoadjuvant ± adjuvant alectinib for 8 weeks entrectinib vemurafenib + cobimetinib | MPR |
NCT03088930 | II | Neoadjuvant | IA–IIIA ALK+ ROS1+, MET+ | Crizotinib for 6 weeks | ORR |
NCT01929200 | II | Adjuvant | II–IIIA EGFR+ | icotinib for 1-year adjuvant therapy vs. 2-year | RFS |
NCT03349203 | II | Neoadjuvant and Adjuvant | IIIB or oligometastasis EGFR+ | Icotinib for 8 weeks before surgery and 2 years as adjuvant therapy | ORR |
NCT03749213 | II | Neoadjuvant | IIIA-N2 EGFR+ | Icotinib for 8 weeks as neoadjuvant therapy and for 2 years as adjuvant therapy | ORR |
NCT05165355 | II | Adjuvant | IB–IIA EGFR+ | Furmonertinib for 3 years as adjuvant therapy | 2-year DFS |
NCT04965831 | II | Neoadjuvant and Adjuvant | IIIA–IIIB (N1-N2) EGFR+ | Furmonertinib for 8 weeks before surgery and 2 years as adjuvant therapy | ORR |
NCT04853342 | III | Adjuvant | II–IIIA EGFR+ | Furmonertinib versus placebo ± chemotherapy | DFS |
ORR, overall response rate; DFS, disease-free survival; MPR, major pathological response; RFS, recurrence-free survival; OS, overall survival; EGFR+, EGFR-mutated; ALK+, ALK-rearranged; BRAF+, BRAF-mutated; NTRK+, NTRK-rearranged; ROS1+, ROS1-rearranged; MET+, MET-altered.