Clinical Research Directory

Limertinib Plus Carboplatin and Etoposide for EGFR-mutant NSCLC With SCLC Transformation After EGFR-TKI Progression

This single-center, prospective study and aims to evaluate the efficacy and safety of limertinib combined with etoposide and carboplatin in EGFR-mutant NSCLC patients who develop small-cell lung cancer transformation following progression on EGFR-TKI therapy.

Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of durvalumab + tremelimumab combination therapy + Standard of care (SoC) chemotherapy or durvalumab monotherapy + SoC chemotherapy versus SoC chemotherapy alone as first line treatment in patients with metastatic non small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions.

A Prospective Multicenter Study of the Association Between TCM Syndromes and EGFR-TKI Efficacy in Lung Cancer Patients

The goal of this observational study is to learn about the relationship between TCM body constitution patterns (called "syndromes") and the effectiveness of EGFR-TKI targeted drugs in patients with lung cancer. Approximately 3000 patients with EGFR-mutant non-small cell lung cancer who are about to start or are already taking EGFR-TKI drugs as part of their regular medical care will be invited to join. Participants will be followed for up to 5 years. During routine clinic visits, researchers will collect their TCM information (such as tongue images and pulse readings) and store small samples of their blood, stool, and tongue coating for future research.

Phase II Study of Radiotherapy Followed by Durvalumab and Ceralasertib in Stage III NSCLC Patients With Thoracic Relapses +/- Oligometastases After PACIFIC Regimen

Aim of this phase 2 study is to explore the safety and efficacy of thoracic re-irradiation +/- SBRT to oligometastases (\<3) followed after an interval of 2 weeks by durvalumab and ceralasertib for patients with thoracic relapses +/- oligometastases after PACIFIC or PACIFIC-like (concurrent or sequential chemo-radiotherapy followed by maintenance durvalumab) regimens.

The Role of DNA and RNA in NGS Analyses for Advaced Stage NSCLC Patients

Patients with advanced non-small cell lung cancer (NSCLC) usually undergo biopsies to obtain cytological material on which to perform Next Generation Sequencing (NGS) analysis, with the aim of identifying driver gene mutations that may be targeted by specific therapies. With the development of drugs with specific therapeutic targets, the clinical need for re-biopsy or even repeated biopsies is increasing; these biopsies are necessary to identify the mechanisms of drug resistance in the target lesions. Very often, lung cancer presents with small lesions and/or lesions located in areas that are difficult to reach with traditional biopsy techniques. An alternative way to obtain genetic material is to isolate extracellular vesicles (EVs). These are secreted by almost all cell types, transport bioactive molecules, including nucleic acids (RNA and DNA), enclosed in a double lipid layer, and act as essential mediators in cell-cell communication. EVs are an ideal biomarker for cancer, as the content of EVs originating from tumor cells reflects the molecular and genetic composition of the parent cells. Long-stranded, concentrated EV-DNA is easy to amplify, making it a suitable candidate for NGS analysis. EVs are widely distributed in various body fluids, making them easier to sample using less invasive methods than tumor cells. Recent studies have shown that EVs successfully isolated from bronchoalveolar lavage (BAL) fluid of lung cancer patients contain abundant amounts of dsDNA. In a study of patients with anatomopathologically confirmed NSCLC, the sensitivity and specificity of EGFR genotyping based on BAL EVs were high, and this test showed an even better mutation detection rate than tissue/cytology-based typing. Considering the high positive predictive value of EV genotyping in bronchoalveolar lavage, this study aims to evaluate its feasibility in NGS analyses. The primary objective of the study is to determine the technical feasibility of NGS analysis on EV-DNA/RNA derived from bronchoalveolar lavage in patients with advanced NSCLC. The secondary objective is to determine the sensitivity and specificity of NGS analysis of EV-DNA/RNA derived from bronchoalveolar lavage compared to NGS analysis conducted on bronchoscopic cytological samples in patients with advanced NSCLC.

A Retrospective Observational Study of Nivolumab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC Patients: Real-World Experience in Taiwan (NEOREAL)

The goal of this observational study is to learn about the effectiveness of Nivolumab in combination with chemotherapy as Neoadjuvant therapy for patients with non-small cell lung cancer (NSCLC). The main question it aims to answer is: Does patient with NSCLC in treatment of Nivolumab combined with chemotherapy demonstrate better pCR and PFS ? Is it safe for patient with NSCLC in treatment of Nivolumab combined with chemotherapy ? The data for those participants already receiving nivolumab in combination with chemotherapy as part of their regular medical care for NSCLC will be collected within the designated collection period.

Phase Ib/II Study of Vebreltinib With Furmonertinib in NSCLC Patients With c-Met Amplification After EGFR-TKI Failure

The goal of phase Ib study was to evaluate efficacy and tolerability of the combination of vebreltinib and furmonertinib in patients with locally advanced or metastatic non-small cell lung cancer with c-met amplification after failure of EGFR-TKI treatment; to determine the maximum tolerated dose (MTD), and to evaluate the dose-limiting toxicity (DLT) and (recommended Phase 2 dose) RP2D of vebreltinib with furmonertinib. The goal of phase II study was to evaluate efficacy \[overall response rate (ORR), progression-free survival (PFS), and so on\] of vebreltinib and furmonertinib in patients with locally advanced or metastatic non-small cell lung cancer with c-met amplification after failure of EGFR-TKI treatment.