Clinical trial NCT02350361: Endostar Combination With Chemotherapy and EGFR-TKI in Lung Cancer Rechallenging Treatment After Acquired Resistance.
Official title: A Study of Endostar Combination With Chemotherapy and Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors in Lung Cancer Rechallenging Treatment After Resistance of EGFR-TKI and Tumor Progression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Lung Cancer
Keywords: endostar
angiogenesis
EGFR-TKI
lung caner
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2015-01-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Here we are going to find a method by using available multiple drugs including angiogenesis medicine - Endostar to treat lung cancer patients who acquired resistence from EGFR-TKI but have responsed to it before.

Detailed description: Lung cancer patients who received epidermal growth factor receptor tyrosine kinase inhibitors(EGFR-TKI) will acquiring resistance to the drug. This is a study of using Endostar, an angiogentic medicine, combination with chemotherapy and EGFR-TKI in lung cancer rechallenging treatment after resistance of EGFR-TKI and progression disease.

Eligibility criteria: Inclusion Criteria:

* Patients with pathologic confirmation of NSCLC with tissue diagnosis or cytologic diagnosis, whose NSCLCs are locally advanced or metastatic Stage III-B / IV adenocarcinoma, and are inoperable and incurable with radiotherapy.
* Life expectancy of at least three (3) months after the start of administration of the investigational drug.
* Eastern Cooperative Oncology Group (ECOG) performance Score 0 to 2.
* Patients with at least one tumor lesion that can accurately be measured by CT or MRI in at least one dimension with longest diameter to be recorded as no less than double the slice thickness and \>=10 mm.
* Patient received at least 6 months EGFR-TKI and show tumor progress
* Adequate hematologic hepatic and renal functions based on the normal conditions of chemotherapy
* Patient signed consent form and adherence and geographic location are liable to follow up

Exclusion Criteria:

* CNS metastasis
* Active infection
* Bleeding tendency or blood coagulation dysfunction
* History of neurological or psychiatric disorders, including epilepsy, or dementia
* Pregnancy or breast-feeding women
* Organ transplant long-term use of immunosuppressive drugs
* Arrhythmia need anti-arrhythmic treatment or other risk of heart disease
* Use other targeted drugs during the research
* Other conditions may not allowed to join in this study according to the researcher's judgment

Primary outcomes:
measure: Objective Responese Rate
timeFrame: in two months
Secondary outcomes:
measure: Progression Free Survival
timeFrame: up to six months
measure: Overall Survial
timeFrame: follow up every two months, about two years
measure: Number of Serious Adverse Events
timeFrame: within two months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Li Liang, MD
role: PRINCIPAL_INVESTIGATOR
References: