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Table 5 Summary of ongoing clinical trials for non-small cell lung cancer patients with EGFR exon 20 insertion mutations

From: EGFR exon 20 insertion mutations in advanced non-small-cell lung cancer: current status and perspectives

Phase Title Treatment Primary Outcome Enrollmenta Status NCT Number
I Study of FURMONERTINIB in Patients With NSCLC Having Exon 20 Insertion Mutation Furmonertinib ORR 30 Recruiting NCT04858958
I/II A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors. BDTX-189 Phase II:ORR 200 Recruiting NCT04209465
I/II A Phase 1/2a Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer CLN-081 Safety and Tolerability 80 Recruiting NCT04036682
I/II Assessing an Oral EGFR Inhibitor, DZD9008 in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1) DZD9008 Part B:ORR 220 Recruiting NCT03974022
I/II A Study of FWD1509 in Adults With Non-Small Cell Lung Cancer FWD1509 Safety and Tolerability 130 Recruiting NCT05068024
I/II Study of Poziotinib in Japanese Patients With NSCLC Poziotinib Phase II:ORR 76 Recruiting NCT04402008
I/II A Study of TAK-788 in Adults With Non-Small Cell Lung Cancer TAK-788 ORR 395 Recruiting NCT02716116
II Afatinib and Cetuximab in Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Positive Non-small-cell Lung Cancer Afatinib plus cetuximab DCR after 18 weeks 37 Recruiting NCT03727724
II Almonertinib as Upfront Treatment for Uncommon EGFR Mutation Harboring Non-Small-Cell Lung Cancer Patients: A Multicenter, Open-Label, Phase II Trial Almonertinib ORR 53 Not yet recruiting NCT04553887
II Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer Amivantamab ORR and DOR 780 Recruiting NCT02609776
II First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2) BAY2927088 Safety and Tolerability 250 Not yet recruiting NCT05099172
II Dacomitinib in Lung Cancer With Uncommon EGFR Mutations Dacomitinib ORR 30 Recruiting NCT04504071
II Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Non-Small Cell Lung Cancer JMT101 Combined With Afatinib (or Osimertinib) Safety 48 Recruiting NCT04448379
II A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer Lazertinib and Amivantamab Safety and Tolerability 520 Recruiting NCT04077463
II A Study Osimertinib in Patients With Stage 4 Non-small Cell Lung Cancer With Uncommon EGFR Mutations Osimertinib ORR 37 Recruiting NCT03434418
II Osimertinib Combined With Bevacizumab in the Treatment Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions Metastatic Non-Small Cell Lung Cancer Osimertinib combined with Bevacizumab PFS 20 Recruiting NCT04974879
II Poziotinib in EGFR Exon 20 Mutant Advanced NSCLC Poziotinib ORR 80 Recruiting NCT03066206
II Phase 2 Study of Poziotinib in Patients With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation Poziotinib ORR 603 Recruiting NCT03318939
II Poziotinib and Ramucirumab for the Treatment of EGFR Exon 20 Mutant Stage IV Non-small Cell Lung Cancer Poziotinib and Ramucirumab PFS 36 Not yet recruiting NCT05045404
II Study of Tarloxotinib in Pts With NSCLC (EGFR Exon 20 Insertion, HER2-activating Mutations) & Other Solid Tumors With NRG1/ERBB Gene Fusions Tarloxotinib ORR 60 Terminated NCT03805841
II/III A Study to Evaluate Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) Atezolizumab, Bevacizumab, Carboplatin, and Pemetrexed ORR 700 Recruiting NCT03178552
III TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations TAK-788 Versus Platinum-Based Chemotherapy PFS 318 Recruiting NCT04129502
III A Study to Evaluate the Efficacy and Safety of Toripalimab or Placebo Combined With Chemotherapy in Treatment-naive Advanced NSCLC Toripalimab combined with standard chemotherapy PFS 450 Recruiting NCT03856411
III A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions Amivantamab + Chemotherapy Versus Chemotherapy Alone PFS 300 Recruiting NCT04538664
  1. Abbreviations: NSCLC Non-small cell lung cancer, EGFR Epidermal growth factor receptor, ex Exon, ins Insertion, ORR Objective response rate, DCR Disease control rate, DOR Duration of response, PFS Progress free survival
  2. aNumbers for total study was given