Study of Apatinib as 3rd/4th Line Treatment in Patients With Advanced Non-Squamous Non-small Cell Lung Cancer Harboring Wild-type Epidermal Growth Factor Receptor (EGFR)

NCT02332512 | Unknown Phase 3 DMC

• 1 other identifier: HR-APTN-Ⅲ-NSCLC-02
• Study Type: interventional
• Target: 417
• Locations: 1 country
• Sites: 2

Brief Summary

Apatinib is a new kind of selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2) tyrosine kinase inhibitor (TKI). The investigators have finished the preclinical,phase I and phase II clinical studies and found its promising anti-tumor activity and tolerable toxicities. A disease-control rate of 61.1% and a mPFS of 4.7 months were showed in apatinib phase II study in patients with NSCLC. The study aims to compare the efficacy and safety of apatinib to placebo in advanced non-squamous non-small cell lung cancer patients.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Non-squamous non-small cell lung cancer; Wild-type EGFR; 3rd/4th line treatment; apatinib

Outcome Measures

Primary Outcomes (1)

• Overall Survival（OS)

  Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause.The date the patient was recorded alive of last follow-up.Median time results from unstratified Kaplan-Meier estimates.

  24 months

Secondary Outcomes (5)

• Progression free survival (PFS)

  24 months

• Objective response rate (ORR)

  24 months

• Duration of response (DoR)

  24 months

• Disease control rate (DCR)

  24 months

• Mean Change From Baseline in European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30)

  24 months

Study Arms (2)

Apatinib

EXPERIMENTAL

Apatinib tablet administered orally, 750 mg,once daily until progression

Drug: Apatinib

Placebo

PLACEBO COMPARATOR

Placebo tablet administered orally, once a day until progression

Drug: Placebo

Interventions

Apatinib DRUG

Apatinib

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects \>/= 18 years and \</=70 years of age at the time of Informed Consent.
• Advanced relapsed or refractory predominantly NSCLC with documented wild-type EGFR.
• At least one measurable lesion according to RECIST 1.1.
• Failure of second line of chemotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Patients must have recovered from any AEs of prior treatments before randamization.
• Adequate bone marrow,liver and renal function as assessed by the following laboratory tests conducted within 1 week before randomization. HB ≥ 90g/L; ANC≥1.5×10E+9/L; PLT≥80×10E+9/L; ALT and AST \< 2.5×ULN; TBIL ≤1.25×ULN; Cr ≤1.25×ULN;CL\>45 ml/min.
• Life expectancy of at least three months.
• Written informed consent and the willingness and ability to comply with all aspects of the protocol.

You may not qualify if:

• Presence of types of small-cell, squamous-cell, adeno-squamous-cell lung cancer.
• Pregnant or breast-feeding women.
• Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female≥ 470 ms).Severe or uncontrolled systemic disease such as clinically significant hypertension(systolic pressure \>/= 140 mm Hg and/or diastolic pressure \>/= 90 mm Hg), and Grade III-IV cardiac insufficiency, according to NYHA criteria or echocardiography check: LVEF\<50%.
• Factors to affect oral administration(inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction).
• Coagulation disfunction,hemorrhagic tendency or receiving anticoagulant therapy\>/= CTCAE 2 pneumorrhagia or \>/= CTCAE 3 hemorrhage in other organs within 4 weeks.
• Bone fracture or wounds that was not cured.
• Arterial thrombus or phlebothrombosis within 12 months and taking anticoagulant agents.
• Mental diseases and psychotropic substances abuse.
• Previous treatment with an trial agent within 4 weeks
• Previous treatment with VEGFR,platelet derived growth factor receptor(PDGFR) TKIs.
• Proteinuria ≥ (++) or 24 hours total urine protein \> 1.0 g.
• Other coexisting malignant disease (except basal-cell carcinoma and carcinoma in situ of uterine cervix).

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (2)

Department of Medical Oncology, Cancer Center, Sun Yet-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

apatinib

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Shunjiang Yu

CONTACT

+86-021-68868768; yushunjiang@hrs.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2015
• First Posted: January 6, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: October 1, 2017
• Last Updated: February 24, 2017

Record last verified: 2017-01

Locations

CN (2)