Nonsmall Cell Lung CancerPhase 1NCT03050411
Apatinib Combine With EGFR-TKI for Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer
A Phase 1 study testing Apatinib Mesylate Tablets and EGFR-TKIs (Erlotinib, Gefitinib and Osimertinib) in people with Nonsmall Cell Lung Cancer, run by Peking University Third Hospital at 1 site in China.
Trial summary
Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), including gefitinib demonstrate excellent effect on the treatment of non-small cell lung cancer (NSCLC) patients with EGFR mutations. However, patients who are initially sensitive to the drugs eventually become resistance. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nonsmall Cell Lung Cancer
- What is being tested?
- Apatinib Mesylate Tablets and EGFR-TKIs (Erlotinib, Gefitinib and Osimertinib)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Oct 2019
- Phase
- Phase 1
- 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
- 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 6 months and appeared disease progression.
- 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.
- Aged from 18 to 75 years (18 and 75 years are included).
- Life expectancy ≥12 weeks.
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- Adequate bone marrow reserve and organ function as follows:
- 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).
- Have history of hypertension (less than 135/85mmHg).
- 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.
- Prior treatment with VEGFR tyrosine kinase inhibitors or VEGFR targeting agent.
- Unhealed toxicity of prior anti-cancer treatment (CTCAE Level 1) or surgery.
- Symptomatic Central Nervous System (CNS) metastases.
- 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.
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- 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.
- Prior other malignant disease in 5 years (except carcinoma in situ of cervix, or non melanoma skin cancers, or localized prostate cancer with Gleason ≤6).
- Documented history of neurological or psychiatric disorders, include epilepsy and dementia.
- 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.
- A history of anaphylaxis of apatinib analogue and/or excipient of drugs in this study.
- Other conditions regimented at investigators' discretion.
Trial locations and contacts
1 site in 1 country.
Li Liang, Prof. M.D. contact
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
Li Liang, MD, 13241870816
About this study
Official title: A Study of Apatinib Combine With EGFR-TKI for Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer
Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), including gefitinib demonstrate excellent effect on the treatment of non-small cell lung cancer (NSCLC) patients with EGFR mutations. However, patients who are initially sensitive to the drugs eventually become resistance. Apatinib is a highly selective VEGFR2 inhibitor and reduces the angiogenesis of tumor efficiently. In this study, the investigators aim to explore the efficacy and reasonable dosage of apatinib combining with EGFR-TKI in advanced non-squamous non-small cell lung cancer with EGFR-TKI resistance.
Read the detailed description
Primary Outcome Measure: efficacy and reasonable dosage of the combination of apatinib and EGFR-TKI in advanced non-squamous non-small cell lung cancer with EGFR-TKI resistance.
Secondary Outcome Measures: Progression free survival, overall survival, Side effects.
- Conditions
- Nonsmall Cell Lung Cancer
- Being tested
- Apatinib Mesylate Tablets, EGFR-TKIs (Erlotinib, Gefitinib and Osimertinib)
- Keywords
- Non Small Cell Lung Cancer, EGFR-TKI resistance, Apatinib, anti-angiogenesis 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.
Apatinib Mesylate TabletsDrug
250mg, 500mg, 750mg, q.d., p.o.
EGFR-TKIs (Erlotinib, Gefitinib and Osimertinib)Drug
EGFR-TKIs include but are not limited erlotinib, gefitinib and osimertinib
| Study group | Role | What they receive |
|---|---|---|
| Apatinib | Experimental | Apatinib in combination with EGFR-TKIs Receives: Drug: Apatinib Mesylate Tablets; Drug: EGFR-TKIs (Erlotinib, Gefitinib and Osimertinib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal Dosage
Optimal dosage of Apatinib which combine with EGFR-TKIs
Measured: 9 months
Progression free survival
PFS is evaluated in 24 months since the treatment begin
Measured: 24 months
Secondary outcomes (2)
Overall survival
Overall survival is evaluated in the 24th month since the treatment began
Measured: 24 months
Side effects
Side effects evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
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 posted10 Feb 2017
- Study startMay 2016
- Primary completionJun 2019 (estimated)
- Study completionOct 2019 (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.
- More trials run by Peking University Third HospitalThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Liang, Peking University Third Hospital
- Investigators
- Li Liang, Prof. M.D., Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050411
- Sponsor's protocol ID
- IRB00006761-2016162
- Status last verified
- Feb 2017
- First submitted
- 9 Jan 2017
- Last updated
- 10 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Apatinib Combine With EGFR-TKI for Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03050411
- Acronym / sponsor ID
- IRB00006761-2016162
- Conditions
- Nonsmall Cell Lung Cancer
- Keywords
- Non Small Cell Lung Cancer, EGFR-TKI resistance, Apatinib, anti-angiogenesis drugs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 10 Feb 2017 (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 inhibitors (EGFR-TKIs), including gefitinib demonstrate excellent effect on the treatment of non-small cell lung cancer (NSCLC) patients with EGFR mutations. However, patients who are initially sensitive to the drugs eventually become resistance. Apatinib is a highly selective VEGFR2 inhibitor and reduces the angiogenesis of tumor efficiently. In this study, the investigators aim to explore the efficacy and reasonable dosage of apatinib combining with EGFR-TKI in advanced non-squamous non-small cell lung cancer with EGFR-TKI resistance.
Detailed description
Primary Outcome Measure: efficacy and reasonable dosage of the combination of apatinib and EGFR-TKI in advanced non-squamous non-small cell lung cancer with EGFR-TKI resistance.
Secondary Outcome Measures: Progression free survival, overall survival, Side effects.
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 Mesylate Tablets, Drug: EGFR-TKIs (Erlotinib, Gefitinib and Osimertinib)Apatinib in combination with EGFR-TKIs |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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 6 months and appeared disease progression.
- 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.
- Aged from 18 to 75 years (18 and 75 years are included).
Key exclusion criteria (19 listed)
- Do not meet the above criteria.
- Prior treatment with VEGFR tyrosine kinase inhibitors or VEGFR targeting agent.
- Unhealed toxicity of prior anti-cancer treatment (CTCAE Level 1) or surgery.
- Symptomatic Central Nervous System (CNS) metastases.
- Uncontrolled hypertension (systolic ≥140mmHg and/or diastolic ≥90mmHg after medication treatment).
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 Mesylate Tablets250mg, 500mg, 750mg, q.d., p.o. | Drug | Apatinib |
| EGFR-TKIs (Erlotinib, Gefitinib and Osimertinib)EGFR-TKIs include but are not limited erlotinib, gefitinib and osimertinib | Drug | Apatinib |
Primary outcome
Optimal Dosage
Time frame: 9 months
Optimal dosage of Apatinib which combine with EGFR-TKIs
Progression free survival
Time frame: 24 months
PFS is evaluated in 24 months since the treatment begin
2 secondary outcomes
Overall survival
Time frame: 24 months
Side effects
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 10 Feb 2017.
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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.
Li Liang, Prof. M.D. contact
Li Liang, Prof. M.D. study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Apatinib Mesylate Tablets and EGFR-TKIs (Erlotinib, Gefitinib and Osimertinib) in people with Nonsmall Cell Lung Cancer, run by Peking University Third Hospital 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 13 inclusion and 19 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 10 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Li Liang, Prof. M.D. (liang.dr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal Dosage (time frame: 9 months). The study lists 2 primary outcomes in all. 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 10 Feb 2017.