Clinical trials: EGFR Uncommon Mutations
Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations
A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation.
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics (PK) of zipalertinib in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) harboring EGFR ex20ins mutations and…
- Trial name
- REZILIENT2 (NCT05967689)
- Testing
- TAS6417, CYP Cocktail, Transporter Cocktail
- Where
- 80 sites in United States, Australia and 10 more
- Volunteers
- 220 people
- Sponsor
- Taiho Oncology, Inc.
Non-small Cell Lung Cancer
Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer
This is a Phase 2b, multicenter, open-label study to evaluate the safety and efficacy of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Non-resistant Uncommon EGFR Mutations Only, Including L861Q, G719X…
- Trial name
- NCT05168566
- Testing
- Sutetinib Maleate Capsule
- Where
- 31 sites in United States, Australia and 1 more
- Volunteers
- 128 people
- Sponsor
- Teligene US
Non-small Cell Lung Cancer
A Phase III Study to Assess the Efficacy and Safety of Almonertinib Versus Platinum-based Chemotherapy as First-line Therapy in Patients With Locally Advanced or Metastatic NSCLC Harbouring Uncommon EGFR Mutation
To assess the efficacy and safety of Almonertinib versus platinum-based chemotherapy as first-line therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring uncommon EGFR mutation.
- Trial name
- NCT04951648
- Testing
- Almonertinib, chemotherapy
- Where
- China
- Volunteers
- 220 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Non-Small Cell Lung Cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer
Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations
This is a Phase 1b, open-label, multi-center, dose-escalation and dose expansion study designed to evaluate the safety, pharmacokinetics (PK), and preliminary antitumor activity of furmonertinib in patients with advanced or…
- Conditions
- Non-Small Cell Lung Cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer, HER2 Exon 20 Mutations
- Trial name
- NCT05364073
- Testing
- Furmonertinib
- Where
- 42 sites in United States, Australia and 9 more
- Volunteers
- 160 people
- Sponsor
- ArriVent BioPharma, Inc.
Mutations in Exons 18 to 21
Pathomolecular Analysis of Rare EGFR Mutations in Advanced NSCLC
While current mutational analyses comprise exons 19 and 21 in which the majority of EGFR-mutations occur, this study aims at investigating the relevance of exon 18 and 20 mutations.
- Trial name
- NCT01215474
- Where
- Germany
- Volunteers
- 500 people
- Sponsor
- Provitro GmbH
Non-Small-Cell Lung Cancer, Metastatic Non-Small-Cell Lung Cancer
Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations
Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of firmonertinib at a dose level of 240 mg QD compared to investigator's choice of osimertinib (80 mg QD) or afatinib (40 mg QD) in…
- Conditions
- Non-Small-Cell Lung Cancer, Metastatic Non-Small-Cell Lung Cancer, Advanced Non-Small-Cell Lung Cancer, EGFR P-Loop and Alpha C-Helix Compressing
- Trial name
- NCT07185997
- Testing
- Firmonertinib, EGFR-TKI inhibitor based on investigator's choice
- Where
- 139 sites in United States, Australia and 15 more
- Volunteers
- 480 people
- Sponsor
- ArriVent BioPharma, Inc.
Non-small Cell Lung Cancer
A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC
The main objective of the study will be to evaluate the efficacy of sutetinib maleate capsules in participants with locally advanced or metastatic non-small cell lung cancer NSCLC (uncommon EGFR mutations only).
- Trial name
- NCT06010329
- Testing
- Sutetinib Maleate Capsule
- Where
- 9 sites in United States
- Volunteers
- 66 people
- Sponsor
- Teligene US
Non-Small Cell Lung Cancer, Advanced Non-Small Cell Squamous Lung Cancer
Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations
BDTX-1535-101 is an open-label, Phase 1 dose escalation and Phase 2 multiple cohort study designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous system (CNS) activity, and antitumor activity of…
- Conditions
- Non-Small Cell Lung Cancer, Advanced Non-Small Cell Squamous Lung Cancer, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Lung Cancer
- Trial name
- NCT05256290
- Testing
- silevertinib (BDTX-1535) monotherapy
- Where
- 25 sites in United States
- Volunteers
- 200 people
- Sponsor
- Black Diamond Therapeutics, Inc.
Lung Cancer, Adjuvant
A Study to Assess Zipalertinib Versus Placebo in Participants With Early Stage NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection
The purpose of this study is to compare the efficacy of zipalertinib versus placebo in participants with early stage resected non-small cell lung cancer (NSCLC) harboring uncommon epidermal growth factor receptor mutation…
- Conditions
- Lung Cancer, Adjuvant, Post-surgical, EGFR
- Trial name
- REZILIENT4 (NCT07128199)
- Testing
- TAS6417
- Where
- 253 sites in United States, Argentina and 22 more
- Volunteers
- 360 people
- Sponsor
- Taiho Oncology, Inc.
NSCLC
Neratinib Tablets in the Treatment of Advanced NSCLC With Rare EGFR Mutations
Single-arm, open-label, multicenter phase II clinical study
- Trial name
- CVL009-2001 (NCT06029816)
- Testing
- Neratinib tablets
- Where
- China
- Volunteers
- 42 people
- Sponsor
- Convalife (Shanghai) Co., Ltd.
NSCLC (Advanced Non-small Cell Lung Cancer)
A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations
This Phase1/2, open label, multicenter study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and preliminary anti-tumor activity of BH-30643 in patients with NSCLC having EGFR and/or HER2 mutations.
- Trial name
- SOLARA (NCT06706076)
- Testing
- BH-30643, BH-30643 combo therapy with Carboplatin/Pemetrexed
- Where
- 42 sites in United States, Australia and 7 more
- Volunteers
- 675 people
- Sponsor
- BlossomHill Therapeutics
Treatment, Treatment Side Effects
Assessing an Oral EGFR Inhibitor,YK-209A in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR
This study aimed to evaluate the safety and preliminary efficacy of YK-029A, a novel third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in treated or untreated patients with advanced non-small…
- Trial name
- NCT05767866
- Testing
- YK-029A
- Where
- 35 sites in China
- Volunteers
- 160 people
- Sponsor
- Suzhou Puhe Pharmaceutical Technology Co., LTD
Non-small Cell Lung Cancer
Study to Assess the Efficacy and Safety of Adjuvant Osimertinib in NSCLC With Uncommon EGFRm
This is an open-label, multi-centre, single-arm study assessing the efficacy and safety of osimertinib as adjuvant treatment in stage IB-IIIB (8th AJCC) NSCLC with uncommon EGFRm after receiving complete surgical resection with…
- Trial name
- NCT05546866
- Testing
- Osimertinib
- Where
- 10 sites in China
- Volunteers
- 51 people
- Sponsor
- AstraZeneca
Lung Cancer
Osimertinib Plus Chemotherapy in Uncommon EGFRm NSCLC
This is an open-label, single-arm, multicenter, exploratory Phase II study sponsored by Astrazeneca Investment (China) Co., LTD.
- Trial name
- MINOVA (NCT05215951)
- Testing
- osimertinib
- Where
- 6 sites in China
- Volunteers
- 4 people
- Sponsor
- AstraZeneca
NSCLC, Adjuvant Treatment
A Study to Assess the Efficacy and Safety of Firmonertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB - IIIB NSCLC With Uncommon Epidermal Growth Factor Receptor (EGFR) Mutations, Following Complete Surgical Resection With or Without Adjuvant Chemotherapy（FIRMOST）
This is a Phase 3, global, double-blind, randomized, controlled multicenter clinical study to assess the efficacy and safety of adjuvant treatment with firmonertinib versus placebo in participants with Stage IB-IIIB NSCLC with…
- Trial name
- FIRMOST (NCT07010419)
- Testing
- Firmonertinib
- Where
- 2 sites in China
- Volunteers
- 338 people
- Sponsor
- Allist Pharmaceuticals, Inc.
Non-squamous, Non-Small Cell Lung Cancer
The Study Observes How Long Patients With Non-small Cell Lung Cancer (NSCLC) Benefit From Treatment With Epidermal Growth Factor Tyrosine Kinase Inhibitor (EGFR-TKI) When Given Either for Uncommon Mutations or for Common Mutations in the Sequence Afatinib Followed by Osimertinib
Non-interventional, multi-country, multi-centre cohort study based on existing data from medical records (paper or electronic) or electronic health records of patients with advanced NSCLC harbouring EGFR mutations and treated…
- Trial name
- UpSwinG (NCT04179890)
- Testing
- Afatinib (Gi(l)otrif®), Erlotinib (Tarceva®), Gefitinib (IRESSA®)
- Where
- United Kingdom
- Volunteers
- 462 people
- Sponsor
- Boehringer Ingelheim
HER2-positive Breast Cancer, HER2 Gene Mutation
Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene
Open-label, Phase I-II, first-in-human (FIH) study for A166 monotherapy in HER2-expressing or amplified patients who progressed on or did not respond to available standard therapies.
- Conditions
- HER2-positive Breast Cancer, HER2 Gene Mutation, HER-2 Gene Amplification, HER2 Positive Gastric Cancer
- Trial name
- NCT03602079
- Testing
- A166
- Where
- 10 sites in United States
- Volunteers
- 49 people
- Sponsor
- Klus Pharma Inc.