Endostar Combination With Chemotherapy and EGFR-TKI in Lung Cancer Rechallenging Treatment After Acquired Resistance.

NCT02350361 | Unknown Phase 2

• 1 other identifier: PekingUTH-LL01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

endostar; angiogenesis; EGFR-TKI; lung caner

Outcome Measures

Primary Outcomes (1)

• Objective Responese Rate

  in two months

Secondary Outcomes (3)

• Progression Free Survival

  up to six months

• Overall Survial

  follow up every two months, about two years

• Number of Serious Adverse Events

  within two months

Study Arms (2)

Endostar Arm

EXPERIMENTAL

Gefitinib re-challenging, oral daily use Docetaxel 60mg/m2 and Cisplatin 70mg/m2, 21 days Recombinant human endostatin 15mg/day, day 1 - 14

Drug: Recombinant human endostatin

Standard Arm

ACTIVE COMPARATOR

Gefitinib re-challenging, oral daily use Docetaxel 60mg/m2 and Cisplatin 70mg/m2, 21 days Placebo

Drug: Placebo

Interventions

Recombinant human endostatin DRUG

Recombinant human endostatin 7.5mg/m2

Also known as: Endostar

Endostar Arm

Placebo DRUG

Placebo

Standard Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Endostatins; endostar protein

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors

Study Officials

• Li Liang, MD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Liang, MD

CONTACT

13241870816

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: January 29, 2015
• Study Start: January 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: March 1, 2016
• Last Updated: January 29, 2015

Record last verified: 2015-01

Locations

CN (1)