Clinical trials: Locally Advanced or Metastatic EGFR Mutated NSCLC.
Non-Small Cell Lung Cancer, NSCLC
First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations
Study STX-721-101/PFL-721CI101 is an open label, Phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (PK) exposure, and preliminary antitumor activity of STX-721/PFL-721 in participants with non-small cell lung…
- Conditions
- Non-Small Cell Lung Cancer, NSCLC, EGFR/HER2 Exon 20 Insertion Mutation
- Trial name
- NCT06043817
- Testing
- STX-721/PFL-721 (Escalated), STX-721/PFL-721 (3 dose levels), STX-721/PFL-721 (RP2D)
- Where
- 32 sites in United States, Australia and 6 more
- Volunteers
- 345 people
- Sponsor
- Pierre Fabre Medicament
Non Small Cell Lung Cancer
Aumolertinib Versus Osimertinib As First-line Therapy for Patients with EGFR Mutated Locally Advanced or Metastatic Non-small-cell Lung Cancer
This is a multicenter, randomized, open-label, non-inferiority real world study. The study is designed to evaluate the efficacy and safety of Aumolertinib versus Osimertinib in the first-line treatment of patients with EGFR…
- Trial name
- ANOTHER (NCT06752408)
- Testing
- Aumolertinib, Osimertinib
- Where
- China
- Volunteers
- 316 people
- Sponsor
- Peking Union Medical College Hospital
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
Non-small Cell Lung Cancer
H002 in Patients With EGFR Mutation Locally Advanced or Metastatic NSCLC
This is a phase I/IIa, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of H002 when given orally in patients with EGFR mutation-positive locally…
- Trial name
- NCT05552781
- Testing
- H002 capsule
- Where
- 8 sites in China
- Volunteers
- 76 people
- Sponsor
- RedCloud Bio
Non-Small-Cell Lung Cancer
Combination of Vebreltinib and Osimertinib in Patients with EGFR 21 L858R Mutation Advanced NSCLC
This is a Prospective, open label, single arm study to evaluate the efficacy and safety of Vebreltinib combined with Osimertinib in the treatment of locally advanced or metastatic non-small cell lung cancer with EGFR 21 L858R…
- Trial name
- NCT06827145
- Testing
- Vebreltinib, Osimertinib
- Where
- China
- Volunteers
- 30 people
- Sponsor
- National Cancer Center, China
Non-small Cell Lung Cancer
DZD9008 In Combination With Bevacizumab in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutation (WU-KONG29)
This study tests a combination therapy (i.e., DZD9008 plus bevacizumab) in patients with advanced NSCLC harboring EGFR mutations who have progressed on or after standard of care, which aims to understand whether the combination…
- Trial name
- NCT06276283
- Testing
- DZD9008 plus Bevacizumab
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Dizal Pharmaceuticals
EGFR Activating Mutation, Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
ASKC202 Plus Limertinib as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC
To evaluate the efficacy and safety of ASKC202 combined with limertinib as the first-line treatment for locally advanced or metastatic NSCLC
- Conditions
- EGFR Activating Mutation, Non-Squamous Non-Small Cell Lung Cancer (NSCLC), MET Positive
- Trial name
- NCT07897188
- Testing
- ASKC202, osimertinib, pemetrexed
- Where
- China
- Volunteers
- 425 people
- Sponsor
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.
NSCLC
Poziotinib in Patients With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation
This is a Phase 2, open-label, multicenter study to evaluate the efficacy and the safety/tolerability of poziotinib in two patient cohorts for up to 114 previously treated NSCLC patients with any systemic therapy (57 patients…
- Trial name
- NCT04044170
- Testing
- Poziotinib
- Where
- 26 sites in China, South Korea
- Volunteers
- 5 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Carcinoma
Osimertinib Plus Savolitinib in EGFRm+/MET+ NSCLC Following Prior Osimertinib
This study (the SAVANNAH study) will investigate the efficacy of osimertinib in combination with savolitinib in patients with EGFRm+ and MET+, locally advanced or metastatic NSCLC who have progressed following treatment with…
- Trial name
- SAVANNAH (NCT03778229)
- Testing
- osimertinib, savolitinib
- Where
- 90 sites in United States, Brazil and 11 more
- Volunteers
- 367 people
- Sponsor
- AstraZeneca
Non-Small Cell Lung Cancer Metastatic, Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor
HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer
This study is designed to evaluate the antitumor activity of patritumab deruxtecan in participants with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R) who have received and…
- Trial name
- NCT04619004
- Testing
- Patritumab Deruxtecan (Fixed dose), Patritumab Deruxtecan (Up-Titration)
- Where
- 123 sites in United States, Australia and 14 more
- Volunteers
- 277 people
- Sponsor
- Daiichi Sankyo
Carcinoma, Non-Small-Cell Lung
Afatinib Expanded Access Program
This is an open-label, multi-center, single-arm trial, designed to provide early access to afatinib and to provide additional information on the safety and efficacy of afatinib in advanced NSCLC patients who harbor an EGFR…
- Trial name
- NCT01649284
- Testing
- afatinib
- Where
- 66 sites in United States
- Sponsor
- Boehringer Ingelheim
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.
Locally Advanced or Metastatic EGFR Sensitising Mutation Positive Non Small Cell Lung Cancer
AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
To assess the efficacy and safety of AZD9291 versus a standard of care epidermal growth factor receptor tyrosine kinase inhibitor in patients with locally advanced or Metastatic Non Small Cell Lung Cancer
- Trial name
- FLAURA (NCT02296125)
- Testing
- Erlotinib 150/100 mg, Gefitinib 250 mg
- Where
- 170 sites in United States, Australia and 28 more
- Volunteers
- 674 people
- Sponsor
- AstraZeneca
Non-Small Cell Lung Cancer
A Study to Investigate ANS02 in Participants With EGFR Mutation-Positive Non-Small Cell Lung Cancer
This is a first-in-human (FIH) Phase I/II, multi-center, open-label, study of ANS02, in patients with advanced NSCLC. The study evaluates the safety, tolerability, preliminary efficay, pharmacokinetics, anti-tumor activity of…
- Trial name
- NCT07538804
- Testing
- ANS02
- Where
- 5 sites in United States, China
- Volunteers
- 294 people
- Sponsor
- Avistone Biotechnology Co., Ltd.
Non-Small Cell Lung Cancer
A Study of SH-1028 Tablets Versus Gefitinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
To assess the efficacy and safety of SH-1028 tablets versus Gefitinib, a standard of care epidermal growth factor receptor tyrosine kinase inhibitor, in patients with locally advanced or Metastatic Non Small Cell Lung Cancer
- Trial name
- NCT04239833
- Testing
- SH-1028 tablets, Gefitinib
- Volunteers
- 240 people
- Sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.
Non-Small Cell Lung Cancer
A Phase Ⅰ/Ⅱa Clinical Study of GEN-725 in Combination With Dositinib
This is an open-label phase I/phase II clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of GEN-725 in combination with Dositinib in participants with locally advanced or…
- Trial name
- NCT07362940
- Testing
- GEN-725 tablets + Dositinib mesylate tablets
- Where
- 5 sites in China
- Volunteers
- 110 people
- Sponsor
- Henan Genuine Biotech Co., Ltd.
Carcinoma, Non-Small-Cell Lung
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib
The purpose of this study is to evaluate whether enhanced dermatologic management can reduce incidence of grade greater than or equal to (>=) 2 dermatologic adverse events of interest (DAEIs) when compared with standard-of-care…
- Trial name
- COCOON (NCT06120140)
- Testing
- Amivantamab IV, Amivantamab SC, Lazertinib
- Where
- 93 sites in United States, Argentina and 9 more
- Volunteers
- 305 people
- Sponsor
- Janssen Research & Development, LLC
Carcinoma, Non-Small-Cell Lung
Expanded Access Study of Afatinib in Treatment-naive or Chemotherapy Pre-treated Patients With Non-small Cell Lung Cancer (NSCLC)
To provide expanded access and to evaluate the safety, tolerability and efficacy of afatinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring Epidermal Growth Factor Receptor (EGFR)…
- Trial name
- NCT01931306
- Testing
- Afatinib
- Where
- 8 sites in South Korea
- Sponsor
- Boehringer Ingelheim
Carcinoma, Non-Small-Cell Lung
Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment
Clinical study to investigate the efficacy and safety of savolitinib in combination with osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally…
- Trial name
- SAFFRON (NCT05261399)
- Testing
- Savolitinib, Osimertinib, Pemetrexed
- Where
- 214 sites in United States, Argentina and 25 more
- Volunteers
- 341 people
- Sponsor
- AstraZeneca
Locally Advanced or Metastatic NSCLC
Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of ASK120067 in Locally Advanced and Metastatic Non Small Cell Lung Cancer
ASK120067 Tablets is a Epidermal Growth Factor Receptor (EGFR) mutation selective Tyrosine Kinase Inhibitor which can efficient suppress the EGFR T790M drug-resistant mutation tumor cell in Xenograft mouse model.
- Trial name
- NCT03502850
- Testing
- ASK120067
- Where
- 3 sites in China
- Volunteers
- 507 people
- Sponsor
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.