Table 6 Ongoing Neoadjuvant Clinical Trials Containing Molecularly Targeted Agents (MTAs) for Patients with NSCLC
ClinicalTrials.Gov Identifier (Trial Name if available) | Biomarker(s) | Regimen | Phase | Sample Size | Stage | Primary Endpoint | Estimated or Actual Study Period [reference] |
|---|---|---|---|---|---|---|---|
NCT04181372 | VEGFR FGFR PDGFR c-kit | Anlotinib hydrochloride + Platinum-based chemotherapy | II | 50 | II | Lymph node(N2) downstage rate | December 2019—August 1, 2022 |
NCT04351555 (NeoADAURA) | EGFR | Osimertinib ± Pemetrexed/Carboplatin or Pemetrexed/Cisplatin | III | 328 | II-IIIB (N2) | MPR | December 24, 2020—March 29, 2029 |
NCT04816838 | EGFR | Osimertinib | Not stated | 25 | I-IIIA | ORR | March 2021- October 2025 |
NCT03349203 | EGFR | Icotinib | II | 60 | IIIB or IV | ORR | October 1, 2018—December 30, 2023 |
NCT04926831 | MET exon 14 skipping mutations | Capmatinib | II | 38 | IB-IIIA, N2 and selected IIIB (T3N2 or T4N2) | MPR | September 30, 2021—March 31, 2028 |
NCT04470076 (Neoafa) | EGFR | Afatinib + Pemetrexed, Gemcitabine + Cisplatin + Carboplatin | II | 30 | IIA-IIIB | MPR, ORR | July 10, 2020—July 30, 2023 |
NCT04455594 (ANSWER) | EGFR | Almonertinib | II | 168 | IIIA (N2) | ORR | October 2020—October 2025 |
NCT04302025 | ALK RET ROS1 BRAF MEK1 | Alectinib + chemotherapy versus Entrectinib + chemotherapy versus Vemurafenib + chemotherapy versus Cobimetinib + chemotherapy versus Pralsetinib + chemotherapy | II | 60 | IIA, IIB, IIIA, and select IIIB (T3N2) | MPR | November 6, 2020—August 15, 2028 |
NCT01059188 | EGFR | Cetuximab + Cisplatin + Docetaxel + Radiotherapy | II | 69 | IIIB | PFS | May 3, 2010—September 2021 |
NCT03433469 | EGFR | Osimertinib | II | 27 | I-IIIA | MPR | July 31, 2018—May 31, 2026 |
NCT02347839 (NEGOTIATE) | EGFR | Gefitinib | II | 37 | III (III A-bulky N2, III B) | Resectability rate | January 2016 – January 2022 |
NCT02820116 | EGFR | Icotinib | II | 67 | IIA-IIIB | Complete resection rate | May 2016—April 2023 |
NCT04841811 (APPROACH) | EGFR | Almonertinib | II | 156 | III | ORR, EFS | August 15, 2021—August 15, 2024 |
NCT04648189 | EGFR | Cetuximab | II | 40 | I-IIIA | CTCs | June 1, 2021—November 30, 2022 |
NCT01470716 | EGFR | Erlotinib | II | 26 | II, IIIA | PFS | January 2012—September 2022 |
NCT03749213 | EGFR | Icotinib | II | 36 | IIIA (N2) | ORR | December 1, 2018—December 30, 2024 |