Study of Apatinib in RET Fusion Positive Advanced Non-small Cell Lung Cancer

Phase 2

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Apatinib single agent arm

• Registration Number: NCT02540824
• Lead Sponsor: Tongji University

Brief Summary

RET fusions are present in 1% to 2% of unselected population of non-small cell lung cancer (NSCLC). Existing US Food and Drug Administration-approved inhibitors of RET tyrosine kinase show promising therapeutic effects in a non-small cell lung cancer patients. Apatinib is an oral multi-kinase inhibitors including RET fusions. This study is designed to evaluate the safety and tolerability of Apatinib in patients with RET fusion positive advanced NSCLC.

Detailed Description

To observe objective response rate (ORR) of apatinib in RET fusion positive pre-treated advanced NSCLC.

To observe Progression free survival （PFS）. To assess the overall survival (OS). To assess safety and tolerability. To evaluate quality of life. To explore the relationship between biomarkers and the toxicity/efficacy of apatinib.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-08-29
• Status Verified: 2015-09
• Study First Submitted QC: 2015-09-03
• Last Update Submitted: 2015-09-03
• Study First Posted: 2015-09-04
• Last Update Posted: 2015-09-04
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Aged ≥18 and ≤80 years.
• ECOG performance status of 0 to 1.
• Life expectancy of more than 12 weeks.
• At least one measurable lesion exists.(RECIST 1.1)
• Histologically or cytologic confirmed RET fusion positive advanced Non-small cell lung cancer who failed to prior therapies.
• Required laboratory values including following parameters: ANC: ≥ 1.5 x 10^9/L, Platelet count: ≥ 80 x 10^9/L, Hemoglobin: ≥ 90 g/L, Total bilirubin: ≤ 1.5 x upper limit of normal, ULN, ALT and AST: ≤ 1.5 x ULN, BUN and creatine clearance rate: ≥ 50 mL/min LVEF: ≥ 50% QTcF: < 470 ms
• Signed informed consent
• Females of child-bearing potential must have negative serum pregnancy test. Sexually active male and those having childbearing potential must practice contraception during the study.

Exclusion Criteria

• Squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer
• Subjects with third space fluid that can not be controled by drainage or other methods.
• Obvious cavity or necrosis formed in the tumor
• Uncontrolled hypertension
• Hymoptysis, more than 2.5ml daily
• Thrombosis in 12 months, including pulmonary thrombosis, stroke, or deep venous thrombosis
• Received big surgery, had bone fracture or ulcer in 4 weeks
• Urine protein >++, or urine protein in 24 hours> 1.0g
• pregnant or lactating woman
• Receiving any other antitumor therapy.
• Known history of hypersensitivity to apatinib or any of it components.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apatinib single agent arm	Apatinib single agent arm	Apatinib, single agent, 750mg once daily p.o until disease progression

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	change from baseline in tumor size every 6-8 weeks after the initiation of apatinib, up to 24 months	To evaluate ORR every 6-8 weeks after initiation of apatinib

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	24 months	PFS is evaluated in 24 months since the treatment began
Safety and Tolerability as measured by adverse events	24 months	Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0
overall survival (OS)	24 months	evaluated in the 24th month since the treatment began
quality of life (QOL, measured by questionnaire)	24 months	Change from baseline in Pain on the 11 point short pain scale (SPS-11)

Trial Locations

Locations (1)

Department of Oncology, Shanghai pulmonary hospital; 🇨🇳 Shanghai, China