Non Small Cell Lung CancerPhase 2NCT03461185
Anti-angiogenesis Combine With EGFR-TKI in Advanced Non-squamous Non Small Cell Lung Cancer
A Phase 2 study testing EGFR-TK Inhibitor and Anti-Angiogenic Drugs in people with Non Small Cell Lung Cancer, run by Xinqiao Hospital of Chongqing at 1 site in China.
Trial summary
Epidermal growth factor receptor Tyrosine kinase inhibitor (EGFR TKI) have been approved to treat NSCLC harboring EGFR mutation as first-line therapy. However, the acquired resistance of EGFR-TKI is a common and severe problem.The study explore the superiority of anti-angiogenesis drugs (Apatinib, endostatin… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- EGFR-TK Inhibitor and Anti-Angiogenic Drugs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 20 Feb 2020
- 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
- Aged from 18 to 75 years (18 and 75 years are included)Obtain of informed consent.
- Histologically or cytologically confirmed, inoperable, recurrence or metastasis advanced non-small cell lung cancer (TNM Stage ⅢB or stage Ⅳ), took EGFR-TKI longer than 2 months and appeared Stable disease.
- At least one measurable lesion (helical CT scan long diameter ≥10mm, meet the requirements of the standard Response Evaluation Criteria In Solid Tumors（RESCIST） version 1.1).
- Eastern Cooperative Oncology Group（ECOG）Performance Status（PS） :0-2.
- Life expectancy ≥12 weeks.
- Adequate bone marrow reserve and organ function as follows:
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- Absolute neutrophils count (ANC) ≥1.5 x 10 to the 9th power/L (band neutrophil and segmented neutrophil), platelets > 100 x 10 to the 9th power/L and Hb≥90g/L.
- Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN).
- Alkaline phosphatase (AP), alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 3.0 times ULN (or less than or equal to 5 times ULN in case of known liver involvement.
- Renal: Serum Creatinine less than or equal to 1.25 times upper limit of normal (ULN).
- Females of child-bearing potential must have negative serum pregnancy test. Sexually active males and females (of childbearing potential) willing to practice contraception during the study.
Who cannot join
- Do not meet the above criteria.
- Unhealed toxicity of prior anti-cancer treatment (CTCAE Level 1) or surgery. Uncontrolled hypertension (systolic ≥140mmHg and/or diastolic ≥90mmHg after medication treatment).
- Clinical uncontrolled active infection, such as acute pneumonia, active hepatitis B or C (prior hepatitis B history, despite medication treatment control or not, HBV DNA≥500copies or ≥100IU/ml), etc.
- Arterial thrombosis or venous thrombosis in 6 months, or disposition evidence of thrombosis/bleeding in 2 month (despite severity), hemoptysis in 2 weeks (bright red blood, 1/2 teaspoon).
- Stroke or transient ischemic attack (TIA) in 12 month. Unhealed skin lesions, surgical site, injuries, severe mucous membrane ulcer or bone fracture.
- Cardiac function evaluation: LVEF <50%, a recent history of MI in 6 months, severe/unstable angina or coronary bypass surgery, or cardiac insufficiency ≥ NYHA 2.
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- Prior other malignant disease in 5 years.
- Recent active digestive disease such as duodenal ulcers, ulcerative colitis, ileus, ect., intestinal perforation, intestine fistula, or other conditions may lead to gastrointestinal bleeding or perforation which regimented at investigators' discretion.
- Difficulty swallowing or known malabsorption.
- A history of organ transplantation and long-term immunosuppressive medication.
- Take part in new drug clinical trials within one month or taking part in a trial now.
- Pregnant or lactating woman.
- Other conditions regimented at investigators' discretion.
Trial locations and contacts
1 site in 1 country.
China1 site
XinQiao Hospital
Chongqing, Chongqing Municipality, 400037
cheng zheng tang, professor, 023-68755114 ext. UK, wangjm1987@foxmail.com
ZhengTang Chen, professor
About this study
Official title: Anti-angiogenesis Combine With EGFR-TKI in Advanced Non-squamous Non Small Cell Cancer
Epidermal growth factor receptor Tyrosine kinase inhibitor (EGFR TKI) have been approved to treat NSCLC harboring EGFR mutation as first-line therapy. However, the acquired resistance of EGFR-TKI is a common and severe problem.The study explore the superiority of anti-angiogenesis drugs (Apatinib, endostatin, anlotinib) plus EGFR TKI versus single EGFR-TKI.
Read the detailed description
Non-small-cell lung cancer (NSCLC) is the leading cause from cancer in China. Epidermal growth factor receptor Tyrosine kinase inhibitor (EGFR TKI) have been approved to treat NSCLC harboring EGFR mutation as first-line therapy. However, a large proportion of patients would become acquired resistant of EGFR-TKI after about one year although initially sensitivity. Anti-angiogenesis therapy plus EGFR-TKI has been demonstrated valid and safe in NSCLC patients. Apatinib, endostatin, anlotinib belong to anti-angiogenesis drugs and can inhibit tumor growth. In this study, we plan to recruit NSCLC patients who are assessed as stable disease ( according to RECIST) under treatment of EGFR-TKI. Then, these patients would be divided into two groups: single EGFR-TKI or EGFR-TKI plus anti-angiogenesis drugs. Progression free survival, overall survival and safety are our evaluation events.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- EGFR-TK Inhibitor, Anti-Angiogenic Drugs
- 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.
EGFR-TK InhibitorDrug
EGFR-TKIs include but are not limited erlotinib, gefitinib
Anti-Angiogenic DrugsDrug
Anti-Angiogenic Drugs contain endostatin, apatinib and anlotinib
| Study group | Role | What they receive |
|---|---|---|
| EGFR-TKI plus anti-angiogenesis | Experimental | EGFR-TKI(erlotinib or gefitinib) plus anti-angiogenesis(endostatin or apatinib or anlotinib) Receives: Drug: EGFR-TK Inhibitor; Drug: Anti-Angiogenic Drugs |
| EGFR-TKI | Active comparator | EGFR-TKI(erlotinib or gefitinib) Receives: Drug: EGFR-TK Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival(PFS)
PFS is evaluated in 24 months since the treatment begin
Measured: 24 months
Secondary outcomes (1)
Overall survival (0S)
OS is evaluated in 24 months since the treatment begin
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 posted9 Mar 2018
- Study start1 May 2018 (estimated)
- Primary completion30 Aug 2019 (estimated)
- Study completion20 Feb 2020 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhengtang Chen, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461185
- Sponsor's protocol ID
- xinqiao2018001
- Status last verified
- Mar 2018
- First submitted
- 4 Mar 2018
- Last updated
- 9 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-angiogenesis Combine With EGFR-TKI in Advanced Non-squamous Non Small Cell Cancer
- ClinicalTrials.gov ID
- NCT03461185
- Acronym / sponsor ID
- xinqiao2018001
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 20 Feb 2020 (estimated)
- First posted
- 9 Mar 2018 (actual)
- 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.
Epidermal growth factor receptor Tyrosine kinase inhibitor (EGFR TKI) have been approved to treat NSCLC harboring EGFR mutation as first-line therapy. However, the acquired resistance of EGFR-TKI is a common and severe problem.The study explore the superiority of anti-angiogenesis drugs (Apatinib, endostatin, anlotinib) plus EGFR TKI versus single EGFR-TKI.
Detailed description
Non-small-cell lung cancer (NSCLC) is the leading cause from cancer in China. Epidermal growth factor receptor Tyrosine kinase inhibitor (EGFR TKI) have been approved to treat NSCLC harboring EGFR mutation as first-line therapy. However, a large proportion of patients would become acquired resistant of EGFR-TKI after about one year although initially sensitivity. Anti-angiogenesis therapy plus EGFR-TKI has been demonstrated valid and safe in NSCLC patients. Apatinib, endostatin, anlotinib belong to anti-angiogenesis drugs and can inhibit tumor growth. In this study, we plan to recruit NSCLC patients who are assessed as stable disease ( according to RECIST) under treatment of EGFR-TKI. Then, these patients would be divided into two groups: single EGFR-TKI or EGFR-TKI plus anti-angiogenesis drugs. Progression free survival, overall survival and safety are our evaluation events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGFR-TKI plus anti-angiogenesis | Experimental | Drug: EGFR-TK Inhibitor, Drug: Anti-Angiogenic DrugsEGFR-TKI(erlotinib or gefitinib) plus anti-angiogenesis(endostatin or apatinib or anlotinib) |
| EGFR-TKI | Active comparator | Drug: EGFR-TK InhibitorEGFR-TKI(erlotinib or gefitinib) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged from 18 to 75 years (18 and 75 years are included)Obtain of informed consent.
- Histologically or cytologically confirmed, inoperable, recurrence or metastasis advanced non-small cell lung cancer (TNM Stage ⅢB or stage Ⅳ), took EGFR-TKI longer than 2 months and appeared Stable disease.
- At least one measurable lesion (helical CT scan long diameter ≥10mm, meet the requirements of the standard Response Evaluation Criteria In Solid Tumors（RESCIST） version 1.1).
- Eastern Cooperative Oncology Group（ECOG）Performance Status（PS） :0-2.
- Life expectancy ≥12 weeks.
Key exclusion criteria (13 listed)
- Do not meet the above criteria.
- Unhealed toxicity of prior anti-cancer treatment (CTCAE Level 1) or surgery. Uncontrolled hypertension (systolic ≥140mmHg and/or diastolic ≥90mmHg after medication treatment).
- Clinical uncontrolled active infection, such as acute pneumonia, active hepatitis B or C (prior hepatitis B history, despite medication treatment control or not, HBV DNA≥500copies or ≥100IU/ml), etc.
- Arterial thrombosis or venous thrombosis in 6 months, or disposition evidence of thrombosis/bleeding in 2 month (despite severity), hemoptysis in 2 weeks (bright red blood, 1/2 teaspoon).
- Stroke or transient ischemic attack (TIA) in 12 month. Unhealed skin lesions, surgical site, injuries, severe mucous membrane ulcer or bone fracture.
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 |
|---|---|---|
| EGFR-TK InhibitorEGFR-TKIs include but are not limited erlotinib, gefitinib | Drug | EGFR-TKI, EGFR-TKI plus anti-angiogenesis |
| Anti-Angiogenic DrugsAnti-Angiogenic Drugs contain endostatin, apatinib and anlotinib | Drug | EGFR-TKI plus anti-angiogenesis |
Primary outcome
Progression free survival(PFS)
Time frame: 24 months
PFS is evaluated in 24 months since the treatment begin
1 secondary outcome
Overall survival (0S)
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 9 Mar 2018.
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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 EGFR-TK Inhibitor and Anti-Angiogenic Drugs in people with Non Small Cell Lung Cancer, run by Xinqiao Hospital of Chongqing 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 11 inclusion and 13 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 9 Mar 2018. 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 chen zhengtang, PhD (+86 02368755625, wangjm1987@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival(PFS) (time frame: 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 9 Mar 2018.