Nonsmall Cell Lung CancerPhase 2NCT02974933
Apatinib Mesylate Combined With Pemetrexed in the Treatment of Pretreated Advanced Non-squamous Non-small Cell Lung Cancer
A Phase 2 study testing Apatinib combined with pemetrexed in people with Nonsmall Cell Lung Cancer, run by Wuling Ou at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy of apatinib mesylate combined with pemetrexed alone in advanced non-small cell lung cancer patients in the second or second line of treatment of progression-free survival Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nonsmall Cell Lung Cancer
- What is being tested?
- Apatinib combined with pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Nov 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged from 18 years to 70years.
- Histologically or cytologically confirmed non-squamous non-small cell lung cancer(stage IIIB/IV).
- Measurable lesions as defined by RECIST criteria.
- Locally advanced lung cancer cannot treat with surgery, recurrent or metastatic lung cancer
- ECOG performance status (PS) of 0 to 1.
- Life expectancy ≥3 months.
- Informed consent.
Who cannot join
- Squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer.
- Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation.
- Tumor invade big vessels or close to big vessels (less than 5mm)
- Obvious cavity or necrosis formed in the tumor
- Uncontrolled hypertension
- Myocardial ischemia or infarction more than stage II, cardiac insufficiency.
Show all 17Show fewer
- Abnormal coagulation (INR>1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy
- The active HBV or HCV infection
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix.
- Hemoptysis, more than 2.5ml daily
- Thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis.
- Unhealed bone fracture or wound for long time
- Received big surgery, had bone fracture or ulcer in 4 weeks.
- Urine protein≥++, or urine protein in 24 hours≥1.0g
- Use of CYP3A4 inhibitor within 7 days or CYP3A4 inducer within 12 days prior to enrollment
- Have received prior treatment with VEGFR TKI (Bevacizumab is permitted).
- Pregnant or lactating woman, or woman unwilling to practice contraception during the study.
Trial locations and contacts
1 site in 1 country.
Ou Wu Ling, MD contact
China1 site, 1 recruiting
- Recruiting
Ou wuling
Wuhan, Hubei, 430079
Ou Wu ling, 40, 13469989766 ext. 86, 609700817@qq.com
About this study
Official title: Apatinib Mesylate Combined With Pemetrexed in the Treatment of Pretreated Advanced Non-squamous Non-small Cell Lung Cancer ：Single Arm Exploratory Study
The purpose of this study is to evaluate the efficacy of apatinib mesylate combined with pemetrexed alone in advanced non-small cell lung cancer patients in the second or second line of treatment of progression-free survival
Read the detailed description
It is a one-arm study. The progression-free survival will be evaluated.
- Conditions
- Nonsmall Cell Lung Cancer
- Being tested
- Apatinib combined with pemetrexed
- Keywords
- apatinib, pemetrexed, NSCLC
- 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 combined with pemetrexedDrug
For those pretreated non-squamous non-small cell lung cancer, treat with apatinib 500mg Qd, po.combined with pemetrexed continue until disease progression
| Study group | Role | What they receive |
|---|---|---|
| apatinib | Experimental | combined with pemetrexed Receives: Drug: Apatinib combined with pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
evaluation per 28 days
Measured: 4 weeks
Secondary outcomes (4)
Overall Survival
evaluation per 28 days
Measured: 4 weeks
disease control rate
evaluation per 28 days
Measured: 4 weeks
objective response rate
evaluation per 28 days
Measured: 4 weeks
Adverse Event
evaluation per 28 days
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2017 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonsmall 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuling Ou
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd., Hubei Clinical Research Collaboration Group
- Responsible party
- Sponsor-investigator, Wuling Ou, Hubei Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974933
- Sponsor's protocol ID
- HubeiCH
- Status last verified
- Feb 2017
- First submitted
- 21 Nov 2016
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apatinib Mesylate Combined With Pemetrexed in the Treatment of Pretreated Advanced Non-squamous Non-small Cell Lung Cancer ：Single Arm Exploratory Study
- ClinicalTrials.gov ID
- NCT02974933
- Acronym / sponsor ID
- HubeiCH
- Conditions
- Nonsmall Cell Lung Cancer
- Keywords
- apatinib, pemetrexed, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Wuling OuUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd., Hubei Clinical Research Collaboration Group
- Study start
- Nov 2016 (actual)
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 29 Nov 2016 (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.
The purpose of this study is to evaluate the efficacy of apatinib mesylate combined with pemetrexed alone in advanced non-small cell lung cancer patients in the second or second line of treatment of progression-free survival
Detailed description
It is a one-arm study. The progression-free survival will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| apatinib | Experimental | Drug: Apatinib combined with pemetrexedcombined with pemetrexed |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged from 18 years to 70years.
- Histologically or cytologically confirmed non-squamous non-small cell lung cancer(stage IIIB/IV).
- Measurable lesions as defined by RECIST criteria.
- Locally advanced lung cancer cannot treat with surgery, recurrent or metastatic lung cancer
- ECOG performance status (PS) of 0 to 1.
Key exclusion criteria (17 listed)
- Squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer.
- Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation.
- Tumor invade big vessels or close to big vessels (less than 5mm)
- Obvious cavity or necrosis formed in the tumor
- Uncontrolled hypertension
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 combined with pemetrexedFor those pretreated non-squamous non-small cell lung cancer, treat with apatinib 500mg Qd, po.combined with pemetrexed continue until disease progression | Drug | apatinib |
Primary outcome
progression free survival
Time frame: 4 weeks
evaluation per 28 days
4 secondary outcomes
Overall Survival
Time frame: 4 weeks
disease control rate
Time frame: 4 weeks
objective response rate
Time frame: 4 weeks
Adverse Event
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Ou Wu Ling, MD contact
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 combined with pemetrexed in people with Nonsmall Cell Lung Cancer, run by Wuling Ou 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 7 inclusion and 17 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 17 Feb 2017. 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 Ou Wu Ling, MD (609700817@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: 4 weeks). 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 17 Feb 2017.