Non-small Cell Lung CancerPhase 2NCT02540824
Study of Apatinib in RET Fusion Positive Advanced Non-small Cell Lung Cancer
A Phase 2 study testing Apatinib single agent arm in people with Non-small Cell Lung Cancer, run by Tongji University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Apatinib single agent arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Oncology, Shanghai pulmonary hospital
Shanghai, 200433
Caicun zhou, MD, PhD, 86-65115006-3050, caicunzhoudr@126.com
shengxiang Ren, MD,PhD, harry_ren@126.com
About this study
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.
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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Apatinib single agent arm
- Keywords
- Apatinib, RET, gene fusion, Non-small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib single agent armDrug
Also called YN968D1
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
| Study group | Role | What they receive |
|---|---|---|
| Apatinib single agent arm | Experimental | Apatinib, single agent, 750mg once daily p.o until disease progression Receives: Drug: Apatinib single agent arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
To evaluate ORR every 6-8 weeks after initiation of apatinib
Measured: change from baseline in tumor size every 6-8 weeks after the initiation of apatinib, up to 24 months
Secondary outcomes (4)
Progression Free Survival (PFS)
PFS is evaluated in 24 months since the treatment began
Measured: 24 months
overall survival (OS)
evaluated in the 24th month since the treatment began
Measured: 24 months
Safety and Tolerability as measured by adverse events
Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0
Measured: 24 months
quality of life (QOL, measured by questionnaire)
Change from baseline in Pain on the 11 point short pain scale (SPS-11)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caicun Zhou, Tongji University
- Investigators
- Caicun Zhou, MD,PhD, Principal investigator, Shanghai Pulmonary Hospital, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540824
- Sponsor's protocol ID
- FK-1407
- Status last verified
- Sep 2015
- First submitted
- 29 Aug 2015
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02540824
- Acronym / sponsor ID
- FK-1407
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Apatinib, RET, gene fusion, Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib single agent arm | Experimental | Drug: Apatinib single agent armApatinib, single agent, 750mg once daily p.o until disease progression |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apatinib single agent armAlso: YN968D1For RET-fusion positive advanced NSCLC patients who failed to previous treatment,treat with apatinib, single agent, 750mg once daily, p.o until disease progression | Drug | Apatinib single agent arm |
Primary outcome
Objective Response Rate (ORR)
Time frame: 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
4 secondary outcomes
Progression Free Survival (PFS)
Time frame: 24 months
overall survival (OS)
Time frame: 24 months
Safety and Tolerability as measured by adverse events
Time frame: 24 months
quality of life (QOL, measured by questionnaire)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caicun Zhou, MD,PhD principal investigator
Shanghai Pulmonary Hospital, Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib single agent arm in people with Non-small Cell Lung Cancer, run by Tongji University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caicun Zhou, MD,PhD (86-65115006-3050, caicunzhoudr@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: change from baseline in tumor size every 6-8 weeks after the initiation of apatinib, up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2015.