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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