Anti-angiogenesis Combine With EGFR-TKI in Advanced Non-squamous Non Small Cell Lung Cancer

NCT03461185 | Unknown Phase 2

• 1 other identifier: xinqiao2018001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Epidermal growth factor receptor Tyrosine kinase inhibitor (EGFR TKI) have been approved to treat NSCLC harboring EGFR mutation as first-line therapy. However, the acquired resistance of EGFR-TKI is a common and severe problem.The study explore the superiority of anti-angiogenesis drugs (Apatinib, endostatin, anlotinib) plus EGFR TKI versus single EGFR-TKI.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival(PFS)

  PFS is evaluated in 24 months since the treatment begin

  24 months

Secondary Outcomes (1)

• Overall survival (0S)

  24 months

Study Arms (2)

EGFR-TKI plus anti-angiogenesis

EXPERIMENTAL

EGFR-TKI(erlotinib or gefitinib) plus anti-angiogenesis(endostatin or apatinib or anlotinib)

Drug: EGFR-TK Inhibitor; Drug: Anti-Angiogenic Drugs

EGFR-TKI

ACTIVE COMPARATOR

EGFR-TKI(erlotinib or gefitinib)

Drug: EGFR-TK Inhibitor

Interventions

EGFR-TK Inhibitor DRUG

EGFR-TKIs include but are not limited erlotinib, gefitinib

EGFR-TKI; EGFR-TKI plus anti-angiogenesis

Anti-Angiogenic Drugs DRUG

Anti-Angiogenic Drugs contain endostatin, apatinib and anlotinib

EGFR-TKI plus anti-angiogenesis

Eligibility Criteria

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

You may qualify if:

• Aged from 18 to 75 years (18 and 75 years are included)Obtain of informed consent.
• Histologically or cytologically confirmed, inoperable, recurrence or metastasis advanced non-small cell lung cancer (TNM Stage ⅢB or stage Ⅳ), took EGFR-TKI longer than 2 months and appeared Stable disease.
• At least one measurable lesion (helical CT scan long diameter ≥10mm, meet the requirements of the standard Response Evaluation Criteria In Solid Tumors（RESCIST） version 1.1).
• Eastern Cooperative Oncology Group（ECOG）Performance Status（PS） :0-2.
• Life expectancy ≥12 weeks.
• Adequate bone marrow reserve and organ function as follows:
• Absolute neutrophils count (ANC) ≥1.5 x 10 to the 9th power/L (band neutrophil and segmented neutrophil), platelets \> 100 x 10 to the 9th power/L and Hb≥90g/L.
• Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN).
• Alkaline phosphatase (AP), alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 3.0 times ULN (or less than or equal to 5 times ULN in case of known liver involvement.
• Renal: Serum Creatinine less than or equal to 1.25 times upper limit of normal (ULN).
• Females of child-bearing potential must have negative serum pregnancy test. Sexually active males and females (of childbearing potential) willing to practice contraception during the study.

You may not qualify if:

• Do not meet the above criteria.
• Unhealed toxicity of prior anti-cancer treatment (CTCAE Level 1) or surgery. Uncontrolled hypertension (systolic ≥140mmHg and/or diastolic ≥90mmHg after medication treatment).
• Clinical uncontrolled active infection, such as acute pneumonia, active hepatitis B or C (prior hepatitis B history, despite medication treatment control or not, HBV DNA≥500copies or ≥100IU/ml), etc.
• Arterial thrombosis or venous thrombosis in 6 months, or disposition evidence of thrombosis/bleeding in 2 month (despite severity), hemoptysis in 2 weeks (bright red blood, 1/2 teaspoon).
• Stroke or transient ischemic attack (TIA) in 12 month. Unhealed skin lesions, surgical site, injuries, severe mucous membrane ulcer or bone fracture.
• Cardiac function evaluation: LVEF \<50%, a recent history of MI in 6 months, severe/unstable angina or coronary bypass surgery, or cardiac insufficiency ≥ NYHA 2.
• Prior other malignant disease in 5 years.
• Recent active digestive disease such as duodenal ulcers, ulcerative colitis, ileus, ect., intestinal perforation, intestine fistula, or other conditions may lead to gastrointestinal bleeding or perforation which regimented at investigators' discretion.
• Difficulty swallowing or known malabsorption.
• A history of organ transplantation and long-term immunosuppressive medication.
• Take part in new drug clinical trials within one month or taking part in a trial now.
• Pregnant or lactating woman.
• Other conditions regimented at investigators' discretion.

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing: lead

Study Sites (1)

XinQiao Hospital

Chongqing, Chongqing Municipality, 400037, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Angiogenesis Inhibitors

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Growth Inhibitors; Antineoplastic Agents; Therapeutic Uses

Central Study Contacts

chen zhengtang, PhD

CONTACT

+86 02368755625; wangjm1987@foxmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Xinqiao Hospital of Chongqing

Study Record Dates

• First Submitted: March 4, 2018
• First Posted: March 9, 2018
• Study Start: May 1, 2018
• Primary Completion: August 30, 2019
• Study Completion: February 20, 2020
• Last Updated: March 9, 2018

Record last verified: 2018-03

Locations

CN (1)