Nonsquamous Nonsmall Cell Neoplasm of LungNCT02852798
Apatinib Combined With Docetaxel Monotherapy as Second-line Therapy of Advanced EGFR WT, Non-squamous NSCLC
An observational study of Nonsquamous Nonsmall Cell Neoplasm of Lung, run by Jiangsu ShengDiYa Medicine Co., Ltd..
Trial summary
This is a clinical study of Apatinib Mesylate Tablets combined with docetaxel monotherapy as second-line therapy of advanced EGFR wild-type, non-squamous, non-small-cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonsquamous Nonsmall Cell Neoplasm of Lung
- What is being tested?
- Apatinib Combined With Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Aug 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: advanced EGFR wild-type, non-squamous, non-small-cell lung cancer
Who may be able to join
- Aged ≥18 years old
- Pathologically Confirmed advanced (stage IIIB, and IV) non-squamous, non-small cell lung cancer, with measurable lesions (long diameter of tumor lesion according to CT scanning ≥10 mm, short diameter of lymph nodes according to CT scanning ≥15 mm, thickness according to CT scanning no more than 5 mm, measurable lesions which have not been treated with radiotherapy, cryotherapy or other local treatment)
- EGFR mutation detection confirmed EGFR mutation negative (EGFR wild-type)
- The patients have completed at least 2 cycles of first-line combined chemotherapy (including a platinum-based chemotherapy, 2-week or 3-week regimen). Efficacy evaluation indicates PD. No more than 28 days has passed since the last chemotherapy cycle. Patients who previously received treatment with EGFR-TKI could be included
- ECOG Score: 0-3
- Expected survival period ≥ 3 months
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- The damages caused by other treatments have been recovered (NCI-CTCAE version 4.0 grading ≤ grade 1), the interval for administration of nitrourea or mitomycin ≥ 6 weeks, or administration of other cytotoxic drugs bevacizumab (Avastin), radiotherapy or surgery ≥ 4 weeks, or administration of EGFR TKI molecular target drugs ≥ 2 weeks
- Functions of major organs are normal, i.e. the following criteria should be met:
- Routine blood test results meet the criteria (no blood transfusion or use of blood products, and no use of G-CSF or other hematopoietic stimulating factors within 14 days)
- HB≥90 g/L
- ANC≥15×10^9/L
- PLT≥80×10^9/L
- The following criteria should be met in the biochemical tests:
- TBIL<1.5×ULN
- ALT and AST<2.5×ULN;for patients with liver metastasis, ALT and AST >5×ULN
- Serum Cr≤1.25×ULN or Endogenous creatinine clearance rate>45 ml/min (Cockcroft-Gault formula)
- Women of childbearing age should have taken reliable contraceptive measures, or received pregnancy test (serum or urine) with a negative result within 7 days before being included, and are willing to take appropriate contraceptive measures during the trial and within 8 weeks after last dose of the study drug. Males who have not received sterilization operation should agree to take appropriate contraceptive measures during the trial and within 8 weeks after last dose of the study drug
- The subjects are voluntary to join this study. They have signed the Informed Consent Form and are willing to coordinate with the follow-up with good compliance.
Who cannot join
- Patients with quamous carcinoma (including adenosquamous carcinoma ); small cell lung cancer (including small cell cancer and non-small cell mixed lung cancer)
- Patients with active brain metastasis, carcinomatous meningitis, or spinal compression, or disease of brain or pia mater according to the screening test, imaging, CT or MRI tests (patients who have completed the treatment and in a stable condition 21 days before screening could be included, but brain MRI, CT or venography is required to confirm that there are no brain hemorrhage symptoms)
- Imaging (CT or MRI) results indicate that the distance between the tumor and the large vessel ≤ 5 mm, or the existence of central tumors locally invading the large vessel could be detected
- Imaging (CT or MRI) indicates apparent pulmonary cavity or necrotizing tumors.
- Hypertension out of control (systolic pressure≥140 mmHg or diastolic pressure≥90 mmHg, despite optimal drug therapy)
- Patients with myocardial ischemia or myocardial infarction above grade II, or arrhythmia out of control (including QTc interval ≥450 ms for males and ≥470 ms for females)
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- Patients with cardiac insufficiency grade III~IV according to NYHA standard, or cardiac color ultrasound indicated LVEF <50%
- Abnormal blood coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds, or APTT >1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment
- Patients treated with anticoagulation agents or Vitamin K antagonist such as Warfarin, heparin, or other similar drugs
- Patients who had obvious hemoptysis within 2 months before screening, or experienced daily hemoptysis with a volume more than half a tea spoon (2.5ml) or above
- Patients who experienced bleeding symptoms of clinical significance within 3 months before screening, or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc
- Patients who manifested arterial/venous thrombus events, e.g. cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening
- Known genetic or acquired bleeding or bleeding tendency (such as hemophilia, blood coagulation dysfunction, thrombocytopenia, and hypersplenism, etc.)
- Patients who have unhealed wounds or fractures for a long time
- Patients who received major surgical operations or experienced severe traumatic injuries, bone fracture, or ulcers within 4 weeks before screening
- Patients with obvious factors affecting absorption of oral drugs, such as difficulties in swallowing, chronic diarrhea and intestinal obstruction, etc
- Occurrence of abdominal fistula, gastrointestinal perforation, or intraperitoneal abscess within 6 months before screening
- Patients whose routine urine tests indicate that urine protein ≥ ++ or verifies that the 24-h urine protein quantitation ≥ 1.0 g
- Patients with clinical symptoms, or dropsy of serous cavity requiring surgical treatment (including hydrothorax, ascites, and hydropericardium)
- Patients who have a history of psychotropic drug abuse and are unable to break the habit, or who have a psychogeny
- Patients who have taken part in other drug clinical tests within 4 weeks before screening
- Confirmed ALK genetic abnormality (gene fusion or mutation)
- Patients who formerly suffered from or currently are complicated with other uncured malignant tumors, except basal cell carcinoma, carcinoma in situ of cervix and superficial bladder cancer that have been cured
- Patients who received the treatment with potent CYP3A4 inhibitors within 7 days before screening, or potent CYP3A4 inducers within 12 days before being included
- Pregnant or lactating women, fertile patients who are unwilling or unable to take effective contraceptive measures
- Conditions determined by investigators to possibly affect the clinical study or determination of the study results
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Study of Apatinib Mesylate Tablets Combined With Docetaxel Monotherapy as Second-line Therapy of Advanced EGFR Wild-type, Non-squamous, Non-small-cell Lung Cancer
This is a clinical study of Apatinib Mesylate Tablets combined with docetaxel monotherapy as second-line therapy of advanced EGFR wild-type, non-squamous, non-small-cell lung cancer.
Read the detailed description
In order to seek high-efficiency, low-toxicity anti-angiogenic drugs, Jiangsu Hengrui Medical Co., Ltd has developed an efficient VEGFR2 tyrosine kinase inhibitor (TKI) - Apatinib. This drug works mainly by inhibiting VEGFR2 to produce the anti-angiogenic effects and treat malignant tumors. Apatinib was shown to have good tumor growth-inhibiting activity against lung cancer in both in vivo and in vitro experiments.
This study aims to further validate the efficacy and safety of Apatinib combined with chemotherapeutics in the treatment of advanced EGFR wild-type non-squamous, non-small-cell lung cancer.
- Being tested
- Apatinib Combined With Docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib Combined With DocetaxelDrug
Also called AITAN
Docetaxel 75 mg/ (m2.d)IV gtt 1h d1 q3w Apatinib Mesylate Tablets : 500 mg qd, 4 weeks as one cycle for continuous drug administration
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: 1 year
Secondary outcomes (4)
Overall survival
Measured: 1 year
duration of response
Measured: 1 year
disease control rate
Measured: 1 year
objective remission rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonsquamous Nonsmall Cell Neoplasm of LungStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu ShengDiYa Medicine Co., Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Dongguan People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852798
- Sponsor's protocol ID
- HRSZ201608
- Status last verified
- Aug 2016
- First submitted
- 29 Jul 2016
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Apatinib Mesylate Tablets Combined With Docetaxel Monotherapy as Second-line Therapy of Advanced EGFR Wild-type, Non-squamous, Non-small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02852798
- Acronym / sponsor ID
- HRSZ201608
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jiangsu ShengDiYa Medicine Co., Ltd.University, hospital or other
- Collaborators
- Dongguan People's Hospital
- Study start
- Aug 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 2 Aug 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.
This is a clinical study of Apatinib Mesylate Tablets combined with docetaxel monotherapy as second-line therapy of advanced EGFR wild-type, non-squamous, non-small-cell lung cancer.
Detailed description
In order to seek high-efficiency, low-toxicity anti-angiogenic drugs, Jiangsu Hengrui Medical Co., Ltd has developed an efficient VEGFR2 tyrosine kinase inhibitor (TKI) - Apatinib. This drug works mainly by inhibiting VEGFR2 to produce the anti-angiogenic effects and treat malignant tumors. Apatinib was shown to have good tumor growth-inhibiting activity against lung cancer in both in vivo and in vitro experiments.
This study aims to further validate the efficacy and safety of Apatinib combined with chemotherapeutics in the treatment of advanced EGFR wild-type non-squamous, non-small-cell lung cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- advanced EGFR wild-type, non-squamous, non-small-cell lung cancer
Key inclusion criteria (18 listed)
- Aged ≥18 years old
- Pathologically Confirmed advanced (stage IIIB, and IV) non-squamous, non-small cell lung cancer, with measurable lesions (long diameter of tumor lesion according to CT scanning ≥10 mm, short diameter of lymph nodes according to CT scanning ≥15 mm, thickness according to CT scanning no more than 5 mm, measurable lesions which have not been treated with radiotherapy, cryotherapy or other local treatment)
- EGFR mutation detection confirmed EGFR mutation negative (EGFR wild-type)
- The patients have completed at least 2 cycles of first-line combined chemotherapy (including a platinum-based chemotherapy, 2-week or 3-week regimen). Efficacy evaluation indicates PD. No more than 28 days has passed since the last chemotherapy cycle. Patients who previously received treatment with EGFR-TKI could be included
- ECOG Score: 0-3
Key exclusion criteria (26 listed)
- Patients with quamous carcinoma (including adenosquamous carcinoma ); small cell lung cancer (including small cell cancer and non-small cell mixed lung cancer)
- Patients with active brain metastasis, carcinomatous meningitis, or spinal compression, or disease of brain or pia mater according to the screening test, imaging, CT or MRI tests (patients who have completed the treatment and in a stable condition 21 days before screening could be included, but brain MRI, CT or venography is required to confirm that there are no brain hemorrhage symptoms)
- Imaging (CT or MRI) results indicate that the distance between the tumor and the large vessel ≤ 5 mm, or the existence of central tumors locally invading the large vessel could be detected
- Imaging (CT or MRI) indicates apparent pulmonary cavity or necrotizing tumors.
- Hypertension out of control (systolic pressure≥140 mmHg or diastolic pressure≥90 mmHg, despite optimal drug 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 |
|---|---|---|
| Apatinib Combined With DocetaxelAlso: AITANDocetaxel 75 mg/ (m2.d)IV gtt 1h d1 q3w Apatinib Mesylate Tablets : 500 mg qd, 4 weeks as one cycle for continuous drug administration | Drug | – |
Primary outcome
Progression Free Survival
Time frame: 1 year
4 secondary outcomes
Overall survival
Time frame: 1 year
duration of response
Time frame: 1 year
disease control rate
Time frame: 1 year
objective remission rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonsquamous Nonsmall Cell Neoplasm of Lung, run by Jiangsu ShengDiYa Medicine Co., Ltd..
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 18 inclusion and 26 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 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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 JUN JIA (+86 13829139286, dgryjy@sina.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: 1 year). 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 3 Aug 2016.