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

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Phase II Clinical Trial to Investigate Efficacy and Safety of Apatinib as a Single Agent in RET-fusion Gene Positive Non-small Cell Lung Cancer Who Failed to Previous Treatment.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02540824
• Other study ID #: FK-1407
• Status: Recruiting
• Phase: Phase 2
• First received: August 29, 2015
• Last updated: September 3, 2015
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: September 2015
• Source: Tongji University
• Contact: Caicun Zhou, MD,PhD
• Phone: 86-65115006-3050
• Email: caicunzhoudr[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Apatinib single agent arm
For RET-fusion positive advanced NSCLC patients who failed to previous treatment,treat with apatinib, single agent, 750mg once daily, p.o until disease progression

Locations

Country	Name	City	State
China	Department of Oncology, Shanghai pulmonary hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Tongji University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	To evaluate ORR every 6-8 weeks after initiation of apatinib	change from baseline in tumor size every 6-8 weeks after the initiation of apatinib, up to 24 months	No
Secondary	Progression Free Survival (PFS)	PFS is evaluated in 24 months since the treatment began	24 months	No
Secondary	overall survival (OS)	evaluated in the 24th month since the treatment began	24 months	No
Secondary	Safety and Tolerability as measured by adverse events	Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0	24 months	No
Secondary	quality of life (QOL, measured by questionnaire)	Change from baseline in Pain on the 11 point short pain scale (SPS-11)	24 months	No