EGFR Activating Mutation

12

Review clinical trials related to EGFR Activating Mutation. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

First-line Therapy With EGFR-TKI Combined With Trastuzumab Rezetecan for Advanced NSCLC Harboring EGFR Mutations Concomitant With HER2 Alterations

To explore the efficacy and safety of first-line EGFR-TKI combined with Trastuzumab Rezetecan in advanced NSCLC patients harboring EGFR mutations with concomitant HER2 genomic alterations or HER2 protein expression (1+/2+/3+)

Participants needed: 35
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Yongsheng WangUpdated: Jul 13, 2026
Eligibility criteria

Aged 18-75 years, male or female without restriction; [+8]

Histologically confirmed tumor containing small cell lung cancer components. [+3]

Status: Recruiting

EGFR-TKIs Plus PD-1 in EGFR-Mutant Advanced NSCLC

This study is an open-label, multicenter, single-arm clinical study.

Participants needed: 32
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Nanfang Hospital, Southern Medical UniversityUpdated: Jun 9, 2026Locations: 1
Eligibility criteria

Patients with histologically or cytologically confirmed, previously untreated EG... [+7]

Patients who are ineligible for standard anti-tumor therapy according to routine... [+22]

Status: Recruiting

Pulsatile High-dose Furmonertinib in EGFR-mutant NSCLC With Leptomeningeal Metastasis

The goal of this clinical trial is to clarify the efficacy and safety of the high-dose alternate-day furmonertinib in NSCLC with leptomeningeal metastasis. It will also explore the mechanism by which the high-dose alternate-day administration regimen enhances efficacy from a pharmacokinetic perspective, and investigate the impact of co-occurring mutations on the efficacy and prognosis of furmonertinib in the treatment of EGFR-mutant NSCLC with leptomeningeal metastasis. The main questions it aims to answer are: Does the high-dose alternate-day administration regimen have definite efficacy? Does the high-dose alternate-day administration regimen have favorable safety? Does the high-dose alternate-day administration regimen improve efficacy by increasing the cerebrospinal fluid (CSF) concentration and CSF penetration rate of the drug? Which co-occurring mutations may affect the efficacy and prognosis of patients with EGFR-mutant NSCLC and leptomeningeal metastasis? Participants will enter Cohort A (320mg qod po) or Cohort B (160mg qd po) to receive furmonertinib based on their own willingness and the clinician's decision, until disease, progression or uncontrollable adverse reactions occur. All patients in Cohort A will undergo efficacy and safety evaluation, with some also participating in pharmacokinetic study; patients in Cohort B will only undergo pharmacokinetic study. Efficacy and safety evaluation will be conducted through imaging examinations, neurological function assessment scales, quality of life self-assessment scales, and adverse event records. Pharmacokinetic study will be carried out by detecting the plasma concentrations and CSF concentrations of furmonertinib and its active metabolites, and calculating the CSF penetration rate for evaluation.

Participants needed: 42
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: Guangzhou University of Traditional Chinese MedicineUpdated: Apr 2, 2026Locations: 1
Eligibility criteria

Patients with non-small cell lung cancer (NSCLC) confirmed by histopathological... [+7]

Unable to complete the baseline assessment form [+8]

Status: Not yet recruiting

Prediction of Targeted Therapy Efficacy in EGFR-mutant Lung Cancer Patients Using AI-based Multimodal Data

The main purpose of this study is to explore the value of multimodal imaging information and models in predicting the prognosis of EGFR-positive non-small cell lung cancer patients undergoing targeted therapy, providing a basis for selecting suitable populations for precise tumor treatment and corresponding therapy. We retrospectively analyzed patient case data, extracted preoperative CT images, H\&E-stained whole-slide digital pathology images, and pre- or postoperative genetic testing reports to extract radiomic features of tumor and peritumoral regions. These features were combined with multidimensional pathological features and gene expression distribution characteristics to construct a multimodal radiopathogenomic model, offering more precise prognostic evaluation for lung cancer patients receiving targeted therapy.

Participants needed: 1,000
Trial details
Age: 18-80Biological sex: AllType: ObservationalSponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUpdated: Dec 17, 2025Locations: 1
Eligibility criteria

Age 18-80 years, undergoing radical surgery for lung cancer (R0 resection); [+4]

Patients negative for EGFR; [+5]

Status: Not yet recruiting

High-Dose Firmonertinib Plus Bevacizumab as Neoadjuvant Therapy for Resectable EGFRm Stage II-IIIB NSCLC

This is a Phase II, single-arm, open-label, multicenter clinical study aimed at evaluating the efficacy and safety of Firmonertinib 160 mg combined with Bevacizumab as neoadjuvant therapy in patients with resectable stage II-IIIB Epidermal Growth Factor Receptor(EGFR)-mutated non-small cell lung cancer.

Participants needed: 62
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Peking University Cancer Hospital & InstituteUpdated: Sep 19, 2025Locations: 1
Eligibility criteria

Male or female, aged ≥18 years. [+9]

Presence of small cell lung cancer or mixed pathological types of NSCLC. EGFR ex... [+15]

Status: Recruiting

CSF Analysis in EGFR Mutant Non-Small Cell Lung Cancer With Leptomeningeal Disease

Leptomeningeal disease is malignant seeding of the leptomeninges and presents with a variety of symptoms frequently impacting quality of life. With improvement in treatment options, rates of leptomeningeal disease are increasing and currently found in up to 9% of EGFR mutant NSCLC. Systemic therapy may be more effective if it can target the correct molecular aberration. The molecular characterization of central nervous system disease may differ from disease outside of the central nervous system. The aim of this pilot trial is to evaluate for molecular differences between cerebral spinal fluid (CSF) and blood circulating tumor DNA (ctDNA) through the use of ddPCR and BC Cancer NGS panel molecular testing.

Participants needed: 10
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: British Columbia Cancer AgencyUpdated: Feb 11, 2025Locations: 1
Eligibility criteria

Subject age is greater than or equal to 18 years at the time of signature of inf... [+6]

Inability to undergo a lumbar puncture due to thrombocytopenia, bleeding disorde... [+2]

Status: Recruiting

TY-9591 in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases

This study is to evaluate the efficacy and safety of TY-9591 in first-line treatment of patients with EGFR-sensitive mutation-positive non-small cell lung cancer with brain metastases compared to Osimertinib.

Participants needed: 420
Trial details
Phase: Phase 2Age: 18-80Biological sex: AllType: InterventionalSponsor: TYK Medicines, IncUpdated: Nov 21, 2024Locations: 1
Eligibility criteria

Male or female aged ≥18 years and <80 years. [+11]

Previous treatment with EGFR inhibitor; [+23]

Status: Recruiting

Osimertinib Plus Dalpiciclib in Patients With EGFR-mutant, CDK4/6 Pathway Aberrant, Advanced Non-small Cell Lung Cancer Following Acquired Resistance to Third-generation EGFR TKI: a Phase II Trial

This study is a prospective, single-arm, phase II trial. It is aimed to evaluate the efficacy and safety of the combination of osimertinib and dalpiciclib in patients with EGFR-mutant, CDK4/6 pathway aberrant, advanced NSCLC following acquired resistance to third-generation EGFR TKI.

Participants needed: 32
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Tianjin Medical University Cancer Institute and HospitalUpdated: Apr 16, 2024Locations: 1
Eligibility criteria

ECOG performance status 0 to 2 with a minimum life expectancy of 12 weeks [+6]

Prior treatment with any CDK4/6 inhibitor [+17]

Status: Recruiting

A Prospective Cohort Study to Evaluate Molecular pRognostic Factors and Resistance Mechanisms to Osimertinib in Adjuvant Treatment of Completely Resected pIB-IIIA Non-small Cell Lung Carcinoma With Common EGFR Mutations (L858R and Del19)

IFCT-2202 ROSIE study aims to incorporate a broad-panel centralized NGS testing at baseline in all patients with completely resected NSCLC with common EGFR mutation after confirmation of an optimal preoperative extension assessment and with a centralized review of the quality of the surgical excision. Furthermore, the IFCT-2202 ROSIE study also aims to study the molecular events associated with relapse on, or after osimertinib exposure, that should result in the opportunity to accede to optimal treatment in case of metastatic relapse.

Participants needed: 300
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Intergroupe Francophone de Cancerologie ThoraciqueUpdated: Mar 8, 2024Locations: 36
Eligibility criteria

Signed Informed consent. [+12]

Neoadjuvant anti-cancer treatment (osimertinib and/or chemotherapy or other anti... [+3]

Status: Recruiting

Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO)

To assess the efficacy and safety of TY-9591 versus Osimertinib in patients with locally advanced or Metastatic Non Small Cell Lung Cancer.

Participants needed: 680
Trial details
Phase: Phase 3Age: 18-80Biological sex: AllType: InterventionalSponsor: TYK Medicines, IncUpdated: Jan 30, 2024Locations: 2
Eligibility criteria

Male or female aged ≥18 years and <80 years. [+10]

Previous treatment with EGFR inhibitor; [+22]

Status: Recruiting

Early or Delayed Intervention of Brain Radiotherapy Combined With Almonertinib in EGFR Mutated NSCLC With Brain Metastases

This is a prospective, multicenter, randomized, controlled clinical study of NSCLC patients with intracranial oligo-metastatic EGFR-sensitive mutations treated with EGFR-TKI Almonertinib , according to the implementation time of brain radiotherapy. Patients were randomly divided into two groups, experimental group (early intervention group of brain radiotherapy) : the brain radiotherapy started within 1 month of TKI treatment, the brain radiotherapy here specifically refers to stereotactic radiotherapy; Control group (brain radiotherapy late intervention group) : Brain radiotherapy was given within 3 months after brain progression during TKI treatment. The differences in OS,iPFS, PFS, iORR, safety, neurocognitive function and quality of life between the two groups were compared.

Participants needed: 232
Trial details
Phase: Phase 3Age: 18-75Biological sex: AllType: InterventionalSponsor: Sun Yat-sen UniversityUpdated: Mar 14, 2023Locations: 1
Eligibility criteria

Patients with histologically or cytologically confirmed non-small cell lung canc... [+14]

Status: Not yet recruiting

Safety and Efficacy of Aumolertinib Combined With Anlotinib as 1st Line Treatment in Advanced Lung Cancer EGFR Mutation With TP53 Co-Mutation

The goal of this open, single-arm, exploratory phase II clinical study is to exploratory safety and efficacy in 1st line treatment in advanced lung cancer EGFR mutation with TP53 co-mutation. 47 patients are scheduled to be enrolled. Treatment regimen is aumolertinib 110mg p.o QD and Anlotinib 12mg oral for 2 weeks, three weeks a cycle, until disease progression or intolerable adverse reactions or death.

Participants needed: 47
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Tianjin Medical University Cancer Institute and HospitalUpdated: Mar 21, 2023
Eligibility criteria

Locally advanced or metastatic NSCLC EGFR sensitive mutations (19del and L858R)... [+11]

Squamous cell carcinoma (including adenosquamous carcinoma and undifferentiated... [+15]