Clinical Research Directory

A Study Investigating BG-60366 in Adults With Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer

This is an open-label, multicenter, Phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-60366, a highly potent, selective EGFR-mutation targeted Chimeric Degradation Activation Compound (CDAC). BG-60366 is designed to degrade mutant EGFR, which is a common cause for Non-Small Cell Lung Cancer (NSCLC). This study will evaluate how well BG-60366 works in participants with advanced or metastatic EGFR-mutant NSCLC. The study will be conducted in 2 parts: 1) Phase 1a Dose Escalation and Safety Expansion, and 2) Phase 1b Dose Expansion.

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.

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.

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.

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.

Plasma Exosomes Reveal the Efficacy of Targeted Therapy in Patients With EGFR Mutation in Lung Adenocarcinoma

The objective of this observational study is to explore the therapeutic trajectory of targeted therapy in lung adenocarcinoma patients with epidermal growth factor receptor (EGFR) mutations. The main objective is to identify potential biomarkers that can predict the efficacy of targeted therapy through plasma exosomes and to explore strategies to reverse drug resistance to targeted therapy. Biological specimens and medical imaging data will be collected from patients already receiving targeted therapy as a first-line treatment, and followed-up will be conducted to analyze prognosis based on different patterns.

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.

Lenvatinib in Combination With Carboplatin Pemetrexed and Pembrolizumab for NSCLC With EGFR Mutations

The purpose of this study is to assess the safety and efficacy of pemetrexed + carboplatin + pembrolizumab (MK-3475) with lenvatinib (MK-7902/E7080) in patients with advanced nonsquamous non-small cell lung cancer harboring EGFR mutations.

Neoadjuvant Immunotherapy in EGFR-mutant Localized NSCLC

Phase II, single-arm, open-label single center study that assess clinical feasibility and safety of 3 cycles neoadjuvant Sintilimab plus chemotherapy in EGFR-mutant stage IIB-IIIB NSCLC (excluding N3) followed by optional adjuvant treatment upon investigators' decisions.

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.

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.

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.

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.

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.