Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Durvalumab

Antineoplastic Agents, Immunological

All patients will receive durvalumab for up to 1 months after standard treatment With chemoradiotherapy.

Included patients will receive durvalumab (fixed dose, 1500mg Q4W) until progressive disease and no clinical benefit, intolerable toxicity or patient's wish, for a maximum duration of 12 months. Treatment with durvalumab should start \<5 weeks after last radiotherapy dosing.

Durvalumab Injection

Åslaug Helland, Prof, MD

The main aim is to identify and describe biomarkers in different sample types related to chemoradiation followed by durvalumab treatment for stage III PD-L1 negative and positive non-small cell lung cancer (NSCLC) patients' eligible for curatively intended chemoradiation.

The hypothesis is that clinical differences in course of disease reflect underlying biological characteristics.

This is an open, multinational, phase 2 trial to investigate the Properties of cancer cells before, during and after treatment with the investigational study drug durvalumab in patients with locally advanced non-small celled lung cancer (NSCLC). Both patients with high and low PD-L1 expression are allowed to participate. Durvalumab (PD-L1 inhibitor) will be administered after a period with standardtreatment with chemotherapy and radiationtherapy (chemoradiotherapy) for around 7 weeks. After maximum 5 weeks break after chemoradiotherapy, durvalumab will be given in the same dose to all patients for up to 12 months. The follow-up include a safety follow-up for up to five years, followed by a survival follow-up for up to a total of ten years.

The main aim is to identify and describe biomarkers in different sample types related to chemoradiation followed by durvalumab treatment for stage III PD-L1 negative and positive non-small cell lung cancer (NSCLC) patients' eligible for curatively intended chemoradiation.

The hypothesis is that clinical differences in course of disease reflect underlying biological characteristics.

open, exploratory, multinational, phase 2 trial

Durvalumab(MEDI4736) After chemoRadioTherapy(DART) for NSCLC-a Translational and Biomarker Study

Durvalumab (MEDI4736) After chemoRadioTherapy (DART) for NSCLC Patients - a Phase II Translational and Biomarker Study Investigating PDL1 Positive and Negative Patients

Genetic analyses on feces samples, by use of feces "Cards".

Analyses of TMB in tumour tissue. Patients with high Tumour Mutational Burden, TMB (\> 8.5 mutations per megabase) have a hazard ratio equal to or less than 0.55 as compared to patients with low TMB. Tumor tissue will be analysed in regard to TMB, and several different cut-offs will be evaluated.

To investigate different levels of TMB in tumor tissue compared to blood samples, as predictors for development of clinical response

Transcriptome characterization (RNA-sequencing) on tumour material to investigate this

To investigate urine for predictive biomarkers (ctDNA, miRNA)

Immunological response assessment performed on tumour material from participants.

Immunohistochemistry of PD-L1 assessed on tumour tissue.

Patient reported outcome measurements by standardized Tools; EORTC-QLQ-C30 and LC13.

AstraZeneca

Oslo University Hospital

Prof, MD, Head of Research

Digestive System Diseases

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

Antibodies

Antibodies, Monoclonal

Lenvatinib

Angiogenesis Inhibitors

Immunoglobulins

Liver Extracts

Endothelial Growth Factors

Mitogens

Immunologic Factors

Protein Kinase Inhibitors

Enzyme Inhibitors

Participants receive intravenous (IV) durvalumab at 1500mg on Day 1 of each 28-day cycle. Number of cycles: until unacceptable toxicity develops or \>42 days before liver transplantation (If patients with locally advanced HCC would undergo liver transplant).

Patients receive Lenvatinib 8-12mg(basing on weight), once a day, oral at least 38 days of each 6 weeks cycle until \>7 days before liver transplantation(If patients with locally advanced HCC would undergo liver transplant).

Lenvatinib (Lenvima, Eisai China) is a novel angiogenesis inhibitor which targets vascular endothelial growth factor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor β etc.

Lenvatinib 4 MG

Hao Feng, MD., Ph.D.

Hao Feng, MD, PhD

Jian-jun Zhang, MD

Qiang Xia, MD

This study will evaluate the safety and efficacy of durvalumab in combination with lenvatinib in participants with locally advanced hepatocellular carcinoma before liver transplant and metastatic unresectable HCC.The primary hypothesis of this study are that patients with locally advanced HCC could benefit from durvalumab plus lenvatinib before liver transplant; patients with metastatic unresectable HCC could also benefit from durvalumab plus lenvatinib with respect to: 1)Progression Free Survival (PFS) ; or recurrence-free survival (RFS) if patients with locally advanced HCC underwent liver transplant; 2) Objective Response Rate (ORR); and 3) Overall survival (OS). The investigators design a clinical study to explore whether the combination above as a treatment in patients with advanced and recurrent endometrial carcinoma could prolong PFS and to analyze potential immune biomarker of therapeutic response.

The combination of Lenvatinib and Programmed death-ligand 1 (PD-L1) blocking has great potential in the treatment of locally advanced hepatocellular carcinoma before liver transplant and metastatic unresectable HCC. This trial is designed as a prospective, open label study for 20 patients with locally advanced hepatocellular carcinoma before liver transplant and metastatic unresectable HCC. The aim is to investigate the efficacy of the combination therapy of Lenvatinib 80-120mg daily orally and durvalumab 1500mg by IV infusion every 4 weeks in terms of progression free survival.

Durvalumab and Lenvatinib in Participants With Locally Advanced and Metastatic Hepatocellular Carcinoma ( Dulect2020-1 )

Safety and Efficacy Study of Durvalumab in Combination With Lenvatinib in Participants With Locally Advanced and Metastatic Hepatocellular Carcinoma-- DULECT2020-1 Trial

Defined as time from randomisation to first progression by investigator assessment using modified RECIST 1.1 or death (by any cause in the absence of progression)

If patients with locally advanced HCC would undergo liver transplant after neoadjuvant treatment of Durvalumab and Lenvatinib.RFS is defined as the time from randomization to first documentation of disease recurrence (local, regional, or distant) as assessed by BICR or by pathology consistent with HCC if required per the site's standard of care, or death due to any cause (both cancer and non-cancer causes of death)

Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients.

Defined as the time from randomisation to death due to any cause

An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.

RenJi Hospital

Subjects will receive BC3402 and Durvalumab in a treatment cycle.

Intravenous infusion, once every 2 weeks, 4 weeks/cycle.

BC3402 injection

Intravenous infusion, once every 4 weeks, 4 weeks/cycle.

Durvalumab injection

Jia Fan, MD

Tianshu Liu, MD

Phase Ib: Dose exploration: To assess the safety, tolerability, and determine the recommended Phase 2 dose (RP2D) of BC3402 in combination with durvalumab in subjects with advanced hepatocellular carcinoma (HCC) Phase II: Dose Expansion: To assess the antitumor activity of BC3402 in combination with durvalumab in subjects with advanced HCC.

BC3402 in Combination With Durvalumab in Patients With Advanced Hepatocellular Carcinoma

A Phase Ib/II Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BC3402 in Combination With Durvalumab in Patients With Advanced Hepatocellular Carcinoma

To assess the incidence of dose limiting toxicity (DLT) events at different doses of BC3402 in combination with durvalumab in the treatment of advanced HCC

To assess the AEs of BC3402 in combination with durvalumab in the treatment of advanced HCC.

To assess the ORR of BC3402 in combination with durvalumab in advanced hepatocellular carcinoma (according to RECIST v1.1)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Durvalumab(MEDI4736) After chemoRadioTherapy(DART) for NSCLC-a Translational and Biomarker Study	NCT04392505	Cancer Non Small Cell ... Non Small Cell ... NSCLC NSCLC, Stage II...	Durvalumab Inje...	18 Years -	Oslo University Hospital
Durvalumab and Lenvatinib in Participants With Locally Advanced and Metastatic Hepatocellular Carcinoma ( Dulect2020-1 )	NCT04443322	Liver Carcinoma Liver Transplan...	Durvalumab Inje... Lenvatinib 4 MG	18 Years - 80 Years	RenJi Hospital
BC3402 in Combination With Durvalumab in Patients With Advanced Hepatocellular Carcinoma	NCT06111326	Hepatocellular ...	BC3402 injectio... Durvalumab inje...	18 Years - 75 Years	Biocity Biopharmaceutics Co., Ltd.
Durvalumab and Lenvatinib in Participants With Locally Advanced and Metastatic Hepatocellular Carcinoma ( Dulect2020-1 )	NCT04443322	Liver Carcinoma Liver Transplan...	Durvalumab Inje... Lenvatinib 4 MG	18 Years - 80 Years	RenJi Hospital
Durvalumab(MEDI4736) After chemoRadioTherapy(DART) for NSCLC-a Translational and Biomarker Study	NCT04392505	Cancer Non Small Cell ... Non Small Cell ... NSCLC NSCLC, Stage II...	Durvalumab Inje...	18 Years -	Oslo University Hospital

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