Lung CancerPhase 2NCT02375022
Rh-Endostatin in Combination With Icotinib for Advanced NSCLC With EGFR Mutations
A Phase 2 study testing Endostar and icotinib in people with Lung Cancer, run by Zhejiang University at 1 site in China.
Trial summary
This single-arm pilot study tries to invesitgate how well giving icotinib with rh-endostatin (Endostar®) works in treating patients with advanced stage non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Endostar and icotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Mar 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic documentation of non small cell lung cancer, with activating epidermal growth factor receptor (defined as deletion 19 or exon 21 L858R mutation).
- Stage IV disease according to the 7th Edition of the American Joint Committee on Cancer staging system -Measureable disease
- Life expectancy of >= 12 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- Absolute neutrophil count (ANC) >= 1, 500/mm^3, platelet count >= 100,000/mm^3, hemoglobin >= 9.0 g/dL.
- Total bilirubin =< 1.5 x upper limit of normal (ULN), serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x ULN in patients without liver or bone metastases; < 5 x ULN in patients with liver or bone metastases, cockcroft-Gault calculated creatinine clearance of >= 45 ml/min or creatinine =< 1.5 x ULN.
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- Prothrombin time (PT) =< 1.5 x ULN, partial thromboplastin time (PTT) =< ULN
- Urine dipstick proteinuria < 2+. Patients discovered to have >= 2 + proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate < 1 g of protein in 24 hours.
- Negative pregnancy test done =< 7 days prior to randomization, for women of childbearing potential only.
- Provide informed written consent.
- Willing to return to enrolling institution for follow-up.
- Willing to provide tissue and blood samples for correlative research purposes.
Who cannot join
- Evidence of bleeding diathesis or coagulopathy.
- Evidence of central nervous system involvement or brain metastases confirmed by head CT or brain MRI within 28 days prior to being registered for protocol therapy.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration for protocol therapy.
- Anticipation of need for major surgical procedure during the course of the study.
- Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to registration for protocol therapy.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to registration for protocol therapy.
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- Serious, non-healing wound, ulcer, or bone fracture.
- History of hemoptysis.
- Clinically significant infections as judged by the treating investigator.
- Other active malignancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang University
Hangzhou, Zhejiang, 310000
Qiong Zhao, 0571-87236802, doczq.2008@gmail.com
Ling Peng, 0571-87236800, Drpengling@gmail.com
About this study
Official title: A Study to Evaluate the Efficacy of Rh-Endostatin (Endostar®) in Combination With Icotinib for Advanced Non-Small Cell Lung Cancer With EGFR Mutations
This single-arm pilot study tries to invesitgate how well giving icotinib with rh-endostatin (Endostar®) works in treating patients with advanced stage non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations. Icotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Anti-angiogeneiss drug, such as rh-endostatin, can block tumor growth by inhibiting the ability of tumors to grow new blood vessels and spread. It is not yet known whether icotinib is more effective when given with rh-endostatin in NSCLC patients with EGFR activating mutations.
Read the detailed description
- Open-label, single-arm, prospective pilot study.
- Definition of advanced non small cell lung cancer: stage IIIb or IV. EGFR mutation status: activating mutation (defined as deletion 19 or exon 21 L858R mutation).
- Before starting study treatment, computed tomography scans of the chest, B ultrasound of abdomen, 12-lead electrocardiogram, MRI scan of brain, and a bone scan are required.
- Tumor response, based on investigator-assessed Response Evaluation Criteria in Solid Tumors (RECIST v.1.1), will be evaluated every 6 weeks during treatment.
- Exploratory evaluation will be performed using dynamic contrast enhanced MRI (DCE-MRI).
- QoL will be assessed using the core module, which will be completed by patients at baseline and before each cycle during treatment.
- All patients who prematurely discontinue treatment for any reason will be followed for survival.
- Conditions
- Lung Cancer
- Being tested
- Endostar and icotinib
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endostar and icotinibDrug
Also called Recombinant Human Endostatin Injection, Icotinib Hydrochloride Tablets
Endostar and icotinib are used as combination therapy.
| Study group | Role | What they receive |
|---|---|---|
| Endostar and icotinib | Experimental | Combination of drug: Endostar: 15mg CIV d1-9, Q3w and icotinib: 125mg TID po. If no progressive disease observed, combination treatment will continue until unacceptable toxicity or progressive disease. Receives: Drug: Endostar and icotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Measured: 6 months
Secondary outcomes (2)
Progression free survival
Measured: 12 months
Safety: Number of Participants with Adverse Events
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Simcere Pharmaceutical Co., Ltd., Beta Pharma, Inc.
- Responsible party
- Principal investigator, Qiong Zhao, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375022
- Sponsor's protocol ID
- ZYTOP1501
- Status last verified
- Mar 2015
- First submitted
- 10 Feb 2015
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy of Rh-Endostatin (Endostar®) in Combination With Icotinib for Advanced Non-Small Cell Lung Cancer With EGFR Mutations
- ClinicalTrials.gov ID
- NCT02375022
- Acronym / sponsor ID
- ZYTOP1501
- Conditions
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Simcere Pharmaceutical Co., Ltd., Beta Pharma, Inc.
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 2 Mar 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.
This single-arm pilot study tries to invesitgate how well giving icotinib with rh-endostatin (Endostar®) works in treating patients with advanced stage non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations. Icotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Anti-angiogeneiss drug, such as rh-endostatin, can block tumor growth by inhibiting the ability of tumors to grow new blood vessels and spread. It is not yet known whether icotinib is more effective when given with rh-endostatin in NSCLC patients with EGFR activating mutations.
Detailed description
- Open-label, single-arm, prospective pilot study.
- Definition of advanced non small cell lung cancer: stage IIIb or IV. EGFR mutation status: activating mutation (defined as deletion 19 or exon 21 L858R mutation).
- Before starting study treatment, computed tomography scans of the chest, B ultrasound of abdomen, 12-lead electrocardiogram, MRI scan of brain, and a bone scan are required.
- Tumor response, based on investigator-assessed Response Evaluation Criteria in Solid Tumors (RECIST v.1.1), will be evaluated every 6 weeks during treatment.
- Exploratory evaluation will be performed using dynamic contrast enhanced MRI (DCE-MRI).
- QoL will be assessed using the core module, which will be completed by patients at baseline and before each cycle during treatment.
- All patients who prematurely discontinue treatment for any reason will be followed for survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endostar and icotinib | Experimental | Drug: Endostar and icotinibCombination of drug: Endostar: 15mg CIV d1-9, Q3w and icotinib: 125mg TID po. If no progressive disease observed, combination treatment will continue until unacceptable toxicity or progressive disease. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologic documentation of non small cell lung cancer, with activating epidermal growth factor receptor (defined as deletion 19 or exon 21 L858R mutation).
- Stage IV disease according to the 7th Edition of the American Joint Committee on Cancer staging system -Measureable disease
- Life expectancy of >= 12 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- Absolute neutrophil count (ANC) >= 1, 500/mm^3, platelet count >= 100,000/mm^3, hemoglobin >= 9.0 g/dL.
Key exclusion criteria (10 listed)
- Evidence of bleeding diathesis or coagulopathy.
- Evidence of central nervous system involvement or brain metastases confirmed by head CT or brain MRI within 28 days prior to being registered for protocol therapy.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration for protocol therapy.
- Anticipation of need for major surgical procedure during the course of the study.
- Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to registration for protocol therapy.
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 |
|---|---|---|
| Endostar and icotinibAlso: Recombinant Human Endostatin Injection, Icotinib Hydrochloride TabletsEndostar and icotinib are used as combination therapy. | Drug | Endostar and icotinib |
Primary outcome
Objective response rate
Time frame: 6 months
2 secondary outcomes
Progression free survival
Time frame: 12 months
Safety: Number of Participants with Adverse Events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 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.
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 Endostar and icotinib in people with Lung Cancer, run by Zhejiang 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 12 inclusion and 10 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 24 Mar 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 6 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 24 Mar 2015.