CClinicalTrials.gg
Sign In
Status unknownNCT02540824Updated Sep 4, 2015

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

A Phase 2 interventional study of Apatinib single agent arm in Non-small Cell Lung Cancer, sponsored by Tongji University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-09-04.

Sponsored by Tongji University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Non-small Cell Lung Cancer

Keywords

  • Apatinib
  • RET
  • gene fusion
  • Non-small Cell Lung Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Tongji University is the lead sponsor of 38 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Apatinib single agent arm

    Apatinib, single agent, 750mg once daily p.o until disease progression

    Drug: Apatinib single agent arm

Interventions

  • DrugApatinib 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

    Also known as: YN968D1

06

What researchers measure

Primary outcomes

  1. Objective Response Rate (ORR)

    To evaluate ORR every 6-8 weeks after initiation of apatinib

    Time frame: change from baseline in tumor size every 6-8 weeks after the initiation of apatinib, up to 24 months

Secondary outcomes

  1. Progression Free Survival (PFS)

    PFS is evaluated in 24 months since the treatment began

    Time frame: 24 months

  2. overall survival (OS)

    evaluated in the 24th month since the treatment began

    Time frame: 24 months

  3. Safety and Tolerability as measured by adverse events

    Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0

    Time frame: 24 months

  4. quality of life (QOL, measured by questionnaire)

    Change from baseline in Pain on the 11 point short pain scale (SPS-11)

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
  • Department of Oncology, Shanghai pulmonary hospital
    Shanghai, 200433, China
    • Caicun zhou, MD, PhD · Contact · caicunzhoudr@126.com · 86-65115006-3050
    • shengxiang Ren, MD,PhD · Contact · harry_ren@126.com
    • Shengxiang Ren, MD,PhD · Sub investigator
    • Fengying Wu, MD, · Sub investigator
    • Xiaoxia Chen, MD,PhD · Sub investigator
    • Chunxia Su, MD,PhD · Sub investigator
    • Caicun Zhou, MD,PhD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02540824
Lead sponsor
Tongji University
Responsible party
Caicun Zhou (Professor, Tongji University) — Principal investigator
First posted
Sep 4, 2015
Start date
Jan 2015
Primary completion
Dec 2016 (estimated)
Completion
Dec 2017 (estimated)
Last update
Sep 4, 2015

Study contacts

Caicun Zhou, MD,PhD
Contact
caicunzhoudr@126.com
86-65115006-3050
Caicun Zhou, MD,PhD
principal investigator · Shanghai Pulmonary Hospital, Tongji University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lung Neoplasms→

Other studies from this sponsor

Tongji University

Start the discussion