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

Primary Purpose

Non Small Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

EGFR-TK Inhibitor

Anti-Angiogenic Drugs

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

XinQiao Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EGFR-TKI plus anti-angiogenesis

EGFR-TKI

Arm Description

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

EGFR-TKI(erlotinib or gefitinib)

Outcomes

Primary Outcome Measures

Progression free survival(PFS)

PFS is evaluated in 24 months since the treatment begin

Secondary Outcome Measures

Overall survival (0S)

OS is evaluated in 24 months since the treatment begin

Full Information

NCT ID

NCT03461185

First Posted

March 4, 2018

Last Updated

March 8, 2018

Sponsor

Xinqiao Hospital of Chongqing

1. Study Identification

Unique Protocol Identification Number

NCT03461185

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2018 (Anticipated)

Primary Completion Date

August 30, 2019 (Anticipated)

Study Completion Date

February 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xinqiao Hospital of Chongqing

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

Detailed Description

Non-small-cell lung cancer (NSCLC) is the leading cause from cancer in China. Epidermal growth factor receptor Tyrosine kinase inhibitor (EGFR TKI) have been approved to treat NSCLC harboring EGFR mutation as first-line therapy. However, a large proportion of patients would become acquired resistant of EGFR-TKI after about one year although initially sensitivity. Anti-angiogenesis therapy plus EGFR-TKI has been demonstrated valid and safe in NSCLC patients. Apatinib, endostatin, anlotinib belong to anti-angiogenesis drugs and can inhibit tumor growth. In this study, we plan to recruit NSCLC patients who are assessed as stable disease ( according to RECIST) under treatment of EGFR-TKI. Then, these patients would be divided into two groups: single EGFR-TKI or EGFR-TKI plus anti-angiogenesis drugs. Progression free survival, overall survival and safety are our evaluation events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EGFR-TKI plus anti-angiogenesis

Arm Type

Experimental

Arm Description

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

Arm Title

EGFR-TKI

Arm Type

Active Comparator

Arm Description

EGFR-TKI(erlotinib or gefitinib)

Intervention Type

Drug

Intervention Name(s)

EGFR-TK Inhibitor

Intervention Description

EGFR-TKIs include but are not limited erlotinib, gefitinib

Intervention Type

Drug

Intervention Name(s)

Anti-Angiogenic Drugs

Intervention Description

Anti-Angiogenic Drugs contain endostatin, apatinib and anlotinib

Primary Outcome Measure Information:

Title

Progression free survival(PFS)

Description

PFS is evaluated in 24 months since the treatment begin

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Overall survival (0S)

Description

OS is evaluated in 24 months since the treatment begin

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

chen zhengtang, PhD

Phone

+86 02368755625

wangjm1987@foxmail.com

Facility Information:

Facility Name

XinQiao Hospital

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400037

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

cheng zheng tang, professor

Phone

023-68755114

Ext

wangjm1987@foxmail.com

First Name & Middle Initial & Last Name & Degree

ZhengTang Chen, professor

12. IPD Sharing Statement

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

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