Clinical trials: EGFR-mutated Locally Advanced or Metastatic NSCLC
Non-Small Cell Lung Cancer
Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)
This Phase III study will be conducted to evaluate the efficacy and safety of YH25448 as first-line treatment in locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) patients with EGFR mutations
- Trial name
- NCT04248829
- Testing
- Lazertinib 240 mg/160 mg, Gefitinib 250 mg
- Where
- 80 sites in Australia, Greece and 11 more
- Volunteers
- 393 people
- Sponsor
- Yuhan Corporation
Advanced or Metastatic NSCLC
Phase III Study of HS-10504 Versus Platinum-Based Doublet Chemotherapy in Patients With C797S+ NSCLC
This is a randomized, controlled, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of oral HS-10504 monotherapy versus platinum-based doublet chemotherapy in participants with locally…
- Trial name
- NCT07754123
- Testing
- HS-10504, platinum-based doublet chemotherapy (Pemetrexed and Cisplatin/Carboplatin)
- Volunteers
- 206 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
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
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.
NSCLC
A Study With BPI-1178 and Osimertinib in Advanced Non-small Cell Lung Cancer Patients With EGFR Mutations
BPI-1178 is a novel, orally administered inhibitor of both cyclin-dependent kinase 4 (CDK4) and CDK6 kinase activity. This open-label investigator-initiated trial (IIT) phase I study was designed to evaluate the safety and…
- Trial name
- EGFR (NCT06362980)
- Testing
- BPI-1178, Osimertinib
- Where
- China
- Volunteers
- 20 people
- Sponsor
- National Cancer Center, China
NSCLC
A Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients
A randomized, double-blind, positive controlled phase III study to evaluate the efficacy and safety of BPI-7711 capsule in locally advanced or recurrent/metastatic treatment-naïve non-small cell lung cancer patients with EGFR…
- Trial name
- NCT03866499
- Testing
- BPI-7711, Gefitinib
- Where
- 3 sites in China
- Volunteers
- 369 people
- Sponsor
- Beta Pharma Shanghai
NSCLC
Study of Poziotinib in Japanese Patients With NSCLC
A Phase 1/2, open-label, multicenter study to determine dose, tolerability, safety and efficacy of poziotinib in Japanese patients non-small cell lung cancer (NSCLC).
- Trial name
- NCT04402008
- Testing
- Poziotinib Once Daily Dosing, Poziotinib Twice Daily Dosing, Poziotinib Once Daily Dosing or Twice Daily Dosing as determined in Phase 1
- Where
- 3 sites in Japan
- Volunteers
- 42 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
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
Non-Small-Cell Lung Cancer
Vebreltinib Plus Furmonertinib in Patients With EGFR-mutated Advanced Non-small Cell Lung Cancer and High PD-L1 Expression
This is a single-arm, exploratory phase Ib/II study with a seamless design to evaluate the safety and efficacy of Vebreltinib combined with furmonertinib as first-line treatment in patients with locally advanced or metastatic…
- Trial name
- DUAL-THRUST (NCT07655622)
- Testing
- Vebreltinib, Furmonertinib 80mg
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Second Affiliated Hospital of Nanchang University
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.
Lung Cancer
Early Access Program of Lazertinib in Republic of Korea
This early access program will be conducted to provide access to Lazertinib for adult patients with locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) with T790M mutation-positive after 1st/2nd generation EGFR TKIs…
- Trial name
- NCT04829422
- Testing
- Lazertinib 240 mg
- Sponsor
- Yuhan Corporation
Patients Must Have Histologically or Cytologically Confirmed Locally Advanced or Metastatic NSCLC, EGFR Mutation-negative and ALK Rearrangement-negative
Efficacy and Safety of Ivonescimab Monotherapy as First-Line Treatment for PD-L1-Positive, Driver Gene-Negative, Locally Advanced or Metastatic NSCLC: A Multicenter, Prospective, Real-World Cohort Study
The treatment decisions, assessment schedule, and study procedures in this research will adhere to the routine clinical practice of each participating center.
- Conditions
- Patients Must Have Histologically or Cytologically Confirmed Locally Advanced or Metastatic NSCLC, EGFR Mutation-negative and ALK Rearrangement-negative, Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score of 0 to 2, No Prior Systemic Therapy Received for the Advanced or Metastatic Disease
- Trial name
- PROMISE (NCT07696832)
- Testing
- Ivonescimab Injection
- Where
- China
- Volunteers
- 265 people
- Sponsor
- Guangdong Association of Clinical Trials
Non-Small Cell Lung Cancer, EGFR Exon 20 Insertion Mutation
Study of BEBT-109 in Subjects With EGFR Exon 20 Insertion Mutations Non-Small Cell Lung Cancer
This study is an open-label, multicenter Phase II trial, planning to enroll 200 subjects, using BEBT-109 capsules as monotherapy, aimed at evaluating the efficacy and safety of BEBT-109 capsules in subjects with Epidermal Growth…
- Trial name
- NCT06706713
- Testing
- BEBT-109 Capsule
- Where
- 2 sites in China
- Volunteers
- 200 people
- Sponsor
- BeBetter Med Inc
Non Small Cell Lung Cancer
DZD6008 Combination Therapy in Patients With Locally Advanced or Metastatic NSCLC With EGFR Mutation (TIAN-SHAN7)
This study is designed to evaluate safety and antitumor activity of DZD6008 combination therapy in patients with advanced Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutations.
- Trial name
- NCT07070440
- Testing
- DZD6008, Pemetrexed, Carboplatin
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Dizal Pharmaceuticals
Carcinoma, Non-Small-Cell Lung
An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)
To evaluate the safety and tolerability of afatinib (Giotrif) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s) and have never been treated with an EGFR-TKI
- Trial name
- NCT01853826
- Testing
- Afatinib
- Where
- 118 sites in Australia, Austria and 9 more
- Volunteers
- 481 people
- Sponsor
- Boehringer Ingelheim
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
To Evaluate OBI-833/OBI-821 in Combination With First-Line Erlotinib in Patients With EGFR-Mutated, Globo H-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
This study is a randomized, active control, open-label, phase 2 trial. Erlotinib-treated NSCLC patients will be screened for Globo H, and only Globo H+ (H score ≥ 100) subjects are eligible for the study.
- Trial name
- EGFR (NCT05442060)
- Testing
- 30 μg OBI-833/100 μg OBI-821, Erlotinib (150 mg daily)
- Where
- 7 sites in Taiwan
- Volunteers
- 60 people
- Sponsor
- OBI Pharma, Inc
Non-small Cell Lung Cancer
A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC)
The study will evaluate the efficacy and safety of treatment with chemotherapy in combination with osimertinib compared to chemotherapy in combination with placebo in patients whose disease has progressed extracranially following…
- Trial name
- COMPEL (NCT04765059)
- Testing
- Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin
- Where
- 40 sites in United States, China and 4 more
- Volunteers
- 98 people
- Sponsor
- AstraZeneca
Carcinoma, Non-Small-Cell Lung
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
The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with…
- Trial name
- PAPILLON (NCT04538664)
- Testing
- Amivantamab, Pemetrexed, Carboplatin
- Where
- 232 sites in United States, Australia and 24 more
- Volunteers
- 308 people
- Sponsor
- Janssen Research & Development, LLC
Non Small Cell Lung Cancer
A Prospective Study of Firmonertinib as First-line Adaptive Therapy Guided by Dynamic ctDNA (MRD) Changes in Locally Advanced or Metastatic EGFR-mutated Non-small Cell Lung Cancer
Exploring the efficacy and safety of adaptively adjusting treatment regimens based on ctDNA (MRD) status for EGFR mutation-positive NSCLC
- Trial name
- NCT07661173
- Testing
- Firmonertinib, Firmonertinib/pemetrexed/Carboplatin, Firmonertinib/pemetrexed/Carboplatin/Bevacizumab
- Where
- China
- Volunteers
- 154 people
- Sponsor
- Anhui Provincial Cancer Hospital