NCT03389256

Brief Summary

This phase 2 study is designed to evaluate the safety and activity of apatinib,a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2, in combination with EGFR-TKI in NSCLC with T790M-negative after the failure of EGFR-TKI therapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2018

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2018

Completed
12 months until next milestone

Study Start

First participant enrolled

December 30, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

January 3, 2018

Status Verified

December 1, 2017

Enrollment Period

2 years

First QC Date

December 26, 2017

Last Update Submit

December 26, 2017

Conditions

Lung DiseasesNeoplasmsRespiratory Tract DiseasesThoracic NeoplasmsNon-Small-Cell Lung

Keywords

apatinibT790 negativeNSCLC

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS)

    the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse

    up to 24 months

Secondary Outcomes (5)

  • Overall survival (OS)

    up to 36 months

  • Duration of response (DOR)

    up to 24 months

  • Disease Control Rate (DCR)

    24 weeks

  • Overall response rate (ORR)

    24 weeks

  • the quality of life (QoL)

    up to 36 months

Study Arms (2)

apatinib combine with EGFR-TKI

EXPERIMENTAL

Every 4 weeks 1 cycle, evaluated the efficacy and safety once every 2 cycles, treat until disease progression or intolerable toxicity

Drug: ApatinibDrug: EGFR-TKI

EGFR-TKI

ACTIVE COMPARATOR

Every 4 weeks 1 cycle, evaluated the efficacy and safety once every 2 cycles, treat until disease progression or intolerable toxicity

Drug: EGFR-TKI

Interventions

ApatinibDRUG

Apatinib mesylate tablets 250 mg qd po, if the patient can tolerate the toxic side effects, adjust the dose to 500mg qd po after 1 week.

Also known as: apatinib tablets
apatinib combine with EGFR-TKI
EGFR-TKIDRUG

Imatinib tablets, 125 mg tid po; gefitinib tablets, 250 mg qd po; erlotinib tablets, 150 mg qd po

Also known as: Imatinib、Gefitinib or Erlotinib
EGFR-TKIapatinib combine with EGFR-TKI

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed stage IIIB, IV non-squamous non-small cell lung cancer, with measurable lesions (the long axis of tumor lesions ≥ 10mm with CT, the short axis of lymph node lesions ≥ 15mm with CT, the lesions not receive radiotherapy, frozen or other local treatment);
  • Patients with slow progression on first-line EGFR TKI(erlotinib / icotinib / gefitinib) treatment;
  • No T790M mutation including an assessment from tumor biopsy obtained while on or subsequent to the most recent EGFR TKI therapy;
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
  • Life expectancy of more than 3 months;
  • Adequate bone marrow function: WBC ≥ 3.0 ×10 E+9/L, neutrophil ≥ 1.5 × 10 E+9/L, platelets ≥ 80 × 10E+9/L,Hb ≥ 10.0g/dL;a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL), a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤3UNL or ≤5UNL in case of liver metastasis, a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault);
  • Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 8 weeks after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug;
  • the participants volunteered to join this study should sign the informed consent forms, have better compliance in the follow-up;

You may not qualify if:

  • Squamous cell carcinoma (including adenosquamous carcinoma); Small cell lung carcinoma (including small cell carcinoma and non-small cell mixed lung carcinoma);
  • Active brain metastases, cancerous meningitis, patients with spinal cord compression;
  • Rapid progression of the disease or cancer invades vital organs;
  • The distance between the tumor lesion and the large blood vessel is less than 5 mm, or there is a central tumor invading local macrovascular;
  • obvious pulmonary cavity or tumor necrosis;
  • Uncontrollable high blood pressure;
  • Grade Ⅱ or above myocardial ischemia or myocardial infarction or arrhythmia control is not good,Ⅲ \~ Ⅳ grade cardiac insufficiency, or cardiac ultrasonography showed left ventricular ejection fraction (LVEF) \<50% according to the NYHA standard;
  • Have a history of interstitial lung disease or patients with interstitial lung disease;
  • Coagulation abnormalities (INR\> 1.5 or PT\> ULN + 4s or APTT\> 1.5 ULN) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
  • There was significant hemoptysis within 2 months prior to enrollment, or a daily hemoptysis volume is 2.5 ml or above;
  • A clinically significant bleeding symptom or bleeding tendencies such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ and above, or vasculitis that occurred within 3 months prior to enrollment;
  • Aneurysm / venous thrombotic events such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
  • Arterial / venous thrombotic events such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism within 12 months prior to enrollment;
  • Hereditary or acquired bleeding and thrombophilia, such as hemophilia, coagulopathy, thrombocytopenia, hypersplenism；
  • Long-term unhealed wounds or fractures;
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sichuan Cancer Hospital

Chengdu, Sichuan, 610041, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610071, China

Location

MeSH Terms

Conditions

Lung DiseasesNeoplasmsRespiratory Tract DiseasesThoracic Neoplasms

Interventions

apatinibErlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms by Site

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Juan Li, MD

CONTACT

+8613880276636dr.lijuan@gmail.com

Rui Shi, MD

CONTACT

+8613880898008shirui729@hotmail.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
MD

Study Record Dates

First Submitted

December 26, 2017

First Posted

January 3, 2018

Study Start

December 30, 2018

Primary Completion

December 30, 2020

Study Completion

August 30, 2022

Last Updated

January 3, 2018

Record last verified: 2017-12

Locations

CN(3)