Back to results

The Efficacy and Drug Resistance Molecular Biology of Apatinib Combined With EGFR-TK1 Treated for Advanced Slow-progressed Non-Small Cell Lung Cancer (NSCLC)

Primary Purpose

Non Small Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Apatinib（250mg/d） combined with EGFR-TKI

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Apatinib, Non Small Cell Lung Cancer, EGFR TKI, slowly progress

Eligibility Criteria

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

Inclusion Criteria:

Informed consent should be obtained before treatment. Patients with good compliance.
Histologically or cytologically confirmed IIIB/IV NSCLC.
Progress in the treatment of EGFR TKI.
Aged from 18 to 75 years (18 and 75 years are included); Gender Not Required.
ECOG PS 0-1.
Life expectancy ≥ 3 months.
At least one measurable lesion (meet the requirements of the standard Response Evaluation Criteria In Solid Tumors (RESCIST) version 1.1). If the lesions that have received local treatment (radiation, radiofrequency, intervention, etc.) are the only lesions, it is required to have clear imaging progress.

Exclusion Criteria:

Uncontrolled hypertension (systolic ≥140mmHg and/or diastolic ≥90mmHg after medication treatment); Poor control of blood sugar.
Acute phase of cerebral infarction, or recovery period <2 months.
A variety of factors that affect the absorption of oral medications (such as inability to swallow, nausea and vomiting, chronic diarrhea, intestinal obstruction, etc.)
Patients with a risk of gastrointestinal bleeding may not be enrolled, including the following: (1) active digestive ulcer lesions, and fecal occult blood (++); (2) a history of melena and hematemesis within 2 months. Simple fecal occult blood (+) is not an exclusion criterion.
Coagulation abnormality (INR>1.5×ULN, APTT>1.5×ULN), with bleeding tendency.
Urine protein ≥ ++ or confirmed 24-hour urine protein quantitation > 1.0 g.
Pregnant or lactating women.
Severe liver and kidney dysfunction (grade 4) .
Allergic to any ingredient of apatinib mesylate.
A history of abuse of psychotropic substances and are unable to quit smoking or mental disorders.
According to the investigator's judgment, people with concomitant diseases that seriously endanger the safety of the patient or affect the patient's completion of the study.
Surgery, major trauma or fracture, within 4 weeks before the treatment or unhealed wound before treatment.
Severe heart disease, such as grade III or above (NYHA standard) congestive heart failure, grade III or above (CCS standard) angina, a history of myocardial infarction within 6 months before the treatment, or medication treated arrhythmia.
Brain metastasis and meningeal metastasis.

Sites / Locations

The Beijing Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apatinib combined with EGFR-TKI

Arm Description

Apatinib 250 millgram（mg/day（d））combined with EGFR-TKI

Outcomes

Primary Outcome Measures

Objective response rates (ORR)

Objective response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response according to Response Evaluation Criteria in Solid Tumors 1.1（RECIST1.1）

Secondary Outcome Measures

Disease control rate (DCR)

Disease Control Rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease according to radiological assessments.

Overall survival (OS)

Time from randomization to death for any cause.

Progression free survival (PFS)

PFS defined as date of randomization until the date of objectively determined progression defined by Response Evaluation Criteria in Solid Tumors criteria or death from any cause, whichever is first.

Drug safety: Number of participants with treatment-related adverse events

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Full Information

NCT ID

NCT03811054

First Posted

January 14, 2019

Last Updated

January 18, 2019

Sponsor

Beijing Chest Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03811054

Brief Title

The Efficacy and Drug Resistance Molecular Biology of Apatinib Combined With EGFR-TK1 Treated for Advanced Slow-progressed Non-Small Cell Lung Cancer (NSCLC)

Official Title

The Efficacy and Drug Resistance Molecular Biology of Apatinib Combined With EGFR-TK1 Treated for Advanced Slow-progressed Non-Small Cell Lung Cancer (NSCLC)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2018 (Actual)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Chest Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Patients with advanced non-small cell lung cancer (NSCLC) who progress slowly after Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors（EGFR-TKI）resistance. The purpose of this study is to investigate the efficacy and drug resistance mechanism of Apatinib combine with EGFR-TK1 treated for advanced slow progressed non-small cell lung cancer and provide new treatment options.

Detailed Description

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. Previous studies demonstrated that the anti-angiogenesis combined with EGFR-TKI in slow-progressed EGFR mutation-positive non-small cell lung cancer achieved good efficacy and disease control rates, prolonged the progression free survival. The present study is aim to expand the number of samples to monitor resistance-related genes and tumor cells. Furthermore, to investigate the mechanism of anti-angiogenesis combine with EGFR-TKI and provide the theory for the use and promotion of clinically protocols. In this study, the primary objective is the objective response rates and the secondary goal are disease control rates, overall survival, progression free survival and drug safety.

6. Conditions and Keywords

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

Non Small Cell Lung Cancer

Keywords

Apatinib, Non Small Cell Lung Cancer, EGFR TKI, slowly progress

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Apatinib combined with EGFR-TKI

Arm Type

Experimental

Arm Description

Apatinib 250 millgram（mg/day（d））combined with EGFR-TKI

Intervention Type

Drug

Intervention Name(s)

Apatinib（250mg/d） combined with EGFR-TKI

Intervention Description

Patients with advanced non-small cell lung cancer (NSCLC) who had treated with EGFR-TKI and progressed slowly because of resistance are underwent with apatinib mesylate and continuous EGFR-TKI.

Primary Outcome Measure Information:

Title

Objective response rates (ORR)

Description

Time Frame

two years

Secondary Outcome Measure Information:

Title

Disease control rate (DCR)

Description

Disease Control Rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease according to radiological assessments.

Time Frame

two years

Title

Overall survival (OS)

Description

Time from randomization to death for any cause.

Time Frame

two years

Title

Progression free survival (PFS)

Description

PFS defined as date of randomization until the date of objectively determined progression defined by Response Evaluation Criteria in Solid Tumors criteria or death from any cause, whichever is first.

Time Frame

two years

Title

Drug safety: Number of participants with treatment-related adverse events

Description

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time Frame

two years

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: Informed consent should be obtained before treatment. Patients with good compliance. Histologically or cytologically confirmed IIIB/IV NSCLC. Progress in the treatment of EGFR TKI. Aged from 18 to 75 years (18 and 75 years are included); Gender Not Required. ECOG PS 0-1. Life expectancy ≥ 3 months. At least one measurable lesion (meet the requirements of the standard Response Evaluation Criteria In Solid Tumors (RESCIST) version 1.1). If the lesions that have received local treatment (radiation, radiofrequency, intervention, etc.) are the only lesions, it is required to have clear imaging progress. Exclusion Criteria: Uncontrolled hypertension (systolic ≥140mmHg and/or diastolic ≥90mmHg after medication treatment); Poor control of blood sugar. Acute phase of cerebral infarction, or recovery period <2 months. A variety of factors that affect the absorption of oral medications (such as inability to swallow, nausea and vomiting, chronic diarrhea, intestinal obstruction, etc.) Patients with a risk of gastrointestinal bleeding may not be enrolled, including the following: (1) active digestive ulcer lesions, and fecal occult blood (++); (2) a history of melena and hematemesis within 2 months. Simple fecal occult blood (+) is not an exclusion criterion. Coagulation abnormality (INR>1.5×ULN, APTT>1.5×ULN), with bleeding tendency. Urine protein ≥ ++ or confirmed 24-hour urine protein quantitation > 1.0 g. Pregnant or lactating women. Severe liver and kidney dysfunction (grade 4) . Allergic to any ingredient of apatinib mesylate. A history of abuse of psychotropic substances and are unable to quit smoking or mental disorders. According to the investigator's judgment, people with concomitant diseases that seriously endanger the safety of the patient or affect the patient's completion of the study. Surgery, major trauma or fracture, within 4 weeks before the treatment or unhealed wound before treatment. Severe heart disease, such as grade III or above (NYHA standard) congestive heart failure, grade III or above (CCS standard) angina, a history of myocardial infarction within 6 months before the treatment, or medication treated arrhythmia. Brain metastasis and meningeal metastasis.

Central Contact Person:

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

Liyan Xu, MD

Phone

86-89509157

xuliyan2009@yahoo.cn

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

Jing Liu

Phone

86-89509157

Facility Information:

Facility Name

The Beijing Chest Hospital

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liyan Xu, MD

xuliyan2009@yahoo.cn

First Name & Middle Initial & Last Name & Degree

Liyan Xu, MD

12. IPD Sharing Statement

Learn more about this trial

The Efficacy and Drug Resistance Molecular Biology of Apatinib Combined With EGFR-TK1 Treated for Advanced Slow-progressed Non-Small Cell Lung Cancer (NSCLC)

We'll reach out to this number within 24 hrs