Table 3.
Ongoing phase III clinical trials of neoadjuvant and adjuvant EGFR and ALK inhibitors in early NSCLC.
| Experimental agent(s) | Trial ID (NCT#) |
Key eligibility criteria | Experimental regimen | Comparator | Primary endpoint(s) | Estimated PCD |
|---|---|---|---|---|---|---|
| Neoadjuvant NSCLC | ||||||
| Osimertinib | NeoADAURA (NCT04351555) |
Resectable EGFR-mutant nsNSCLC | Osimertinib ± platinum-based chemotherapy | Placebo + platinum-based chemotherapy | MPR | March 2024 |
| Adjuvant NSCLC, EGFR inhibitors | ||||||
| Icotinib |
ICTAN
(NCT01996098) |
Stage IIA-IIIA EGFR-mutant NSCLC | 6- or 12-month Icotinib following chemotherapy | Chemotherapy | DFS | January 2020 |
| Icotinib | EVIDENCE (NCT02448797) |
Stage II-IIIA EGFR-mutant NSCLC | Icotinib | Vinorelbine + Cisplatin a | DFS | December 2020 |
| Erlotinib | ALCHEMIST Treatment Trial A081105 (NCT02193282) |
Completely resected stage IB-IIIA EGFR-mutant nsNSCLC | Erlotinib | Placebo | OS | November 2021 |
| Gefitinib | 4-2016-0763 (NCT03381066) |
Completely resected stage IIA to IIIB EGFR-mutant nsNSCLC |
Gefitinib + Pemetrexed + Cisplatin | Vinorelbine + Cisplatin | DFS | December 2022 |
| Furmonertinib | FORWARD (NCT04853342) |
Completely resected stage II-IIIA EGFR-mutant NSCLC | Furmonertinib | Placebo | DFS | December 2023 |
| Almonertinib | HS-10296-302 (NCT04687241) |
Stage II-IIIB EGFR-mutant NSCLC | Almonertinib | Placebo | DFS | January 2026 |
| Almonertinib | APEX (NCT04762459) |
Completely resected stage II-IIIA EGFR-mutant nsNSCLC | Almonertinib + Pemetrexed + Cisplatin | Pemetrexed + Cisplatin | DFS | May 2026 |
| Adjuvant NSCLC, ALK inhibitors | ||||||
| Crizotinib | ALCHEMIST Treatment Trial A081105 (NCT02201992) |
Completely resected stage IB-IIIA ALK-mutant NSCLC | Crizotinib | Placebo | OS | May 2022 |
| Alectinib | BO40336 (NCT03456076) |
Completely resected stage IB-IIIA ALK-mutant NSCLC | Alectinib | Platinum-based chemotherapy | DFS | June 2023 |
ALK, anaplastic lymphoma kinase; DFS, disease-free survival; EGFR, epidermal growth factor receptor; PCD, primary completion date; MPR, major pathological response; ns, non-squamous; NSCLC, non-small cell lung cancer; OS; overall survival.
Ongoing (trials that are actively recruiting for which efficacy outcomes are not yet available and records have been updated in the last 2 years) phase III trials on neoadjuvant and adjuvant treatment with EGFR and ALK inhibitors for NSCLC listed at CT.gov on 17 March 2021 ordered by treatment setting and estimated primary completion date.
a
Pemetrexed plus cisplatin for adenocarcinoma.