- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02766140
SHR1020 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Squamous Non Small Cell Lung Cancer
January 17, 2019 updated by: Jiangsu HengRui Medicine Co., Ltd.
Multicentre, Randomised, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral SHR1020 Plus Docetaxel Therapy Compared to Placebo Plus Docetaxel Therapy in Patients With Local Advanced or Metastatic or Recurrent Non Squamous Non Small Cell Lung Cancer After Failure of First Line Chemotherapy.
The present trial will be performed to evaluate whether SHR1020 in combination with docetaxel in patients with Local Advanced or Metastatic or recurrent Non Squamous NSCLC is more effective as compared to placebo in combination with docetaxel.
A secondary aim is to obtain safety information as well as information on quality of life of patients treated with SHR1020 in combination with docetaxel.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Shanghai
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Shanghai, Shanghai, China, 200433
- Shanghai pulmonary hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age:18-70 years
- Histologically or cytologically confirmed locally advanced and/or metastatic NSCLC or recurrent NSCLC (≤9 months from date of diagnosis to randomized ), epidermal growth factor receptor-wild type, Anaplastic Lymphoma Kinase-wild type or unknown mutation
- At least one lesion that can be accurately measured and has not been received local treatments such as radiotherapy and cryotherapy
- Relapse or failure of one first line prior platinum-based chemotherapy
- Eastern Cooperative Oncology Group performance status 0 or 1
- Life expectancy of at least 12 weeks
- Adequate organ and bone marrow function as defined below(no blood transfusion or drugs for leucopenia and Platelet within 14 days before screening): (1) HB≥90g/l (2) ANC≥1.5×10^9/l (3) PLT≥100×10^9/l (4) BIL<1.25×upper limit of normal (5) Alanine Aminotransferase and/or AST<2.5×upper limit of normal (< 5×upper limit of normal for patients with liver metastasis) (6) Cr≤1.25×upper limit of normal or Creatinine clearance rate>45ml/min ( Cockcroft-Gault Formula) (7) Cholesterol≤1.5×upper limit of normal, Triglyceride≤2.5×upper limit of normal (8) Left ventricular ejection fraction (LVEF) greater than lower limit of normal
- Female: child bearing potential, a negative urine or serum pregnancy test result within 7 days before randomisation, agree to use effective contraception while on treatment and for at least 6 months after end of treatment;male: agree to use effective contraception while on treatment and for at least 6 months after end of treatment
- Patient has given written informed consent
Exclusion Criteria:
- More than one prior chemotherapy regimen for advanced and/or metastatic or recurrent NSCLC (except neoadjuvant or adjuvant chemotherapy )
- Previous therapy with other VEGFR inhibitors、recombinant human endostatin、 docetaxel or immunotherapy for treatment of NSCLC
- History of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80 (Tween 80), Hypersensitivity to the excipients of the trial drugs or contrast medium
- Have clinically significant cavity effusion,such as pleural effusion、 pericardial effusion or ascites and require clinical intervention
- Active brain metastases
- Other malignancy within the past (including primary brain tumor or Leptomeningeal tumor), other than basal cell skin cancer or carcinoma in situ of the cervix
- Significant weight loss (>10%) within the past 6 weeks
- Persistence of clinically relevant therapy related toxicities from previous therapy (greater than Common Terminology Criteria for Adverse Event(CTCAE) 4.0 grade 1)
- Treatment with surgery, chemotherapy, hormone therapy, radiotherapy, immunomodulation or monoclonal antibody therapy within the past 4 weeks and traditional chinese medicine for antitumor therapy within the past 2 weeks before start of therapy
- Radiographical evidence of cavitary or necrotic tumours
- Centrally located tumours with radiographical evidence (CT or MRI) of local invasion of major blood vessels
- Greater than CTCAE 4.0 grade 2 pulmonary hemorrhage within the past one month before screening
- History of clinically significant haemoptysis within the past 3 months (more than half a teaspoon within 24 hours )
- History of major thrombotic or clinically relevant major bleeding event in the past 6 months
Prothrombin time (PT) and/or partial thromboplastin time (PTT) > 50% of devi
- ation of upper limit of normal
- Application of anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogus, if INR≤1.5, with the purpose of prevention,the use of low-dose warfarin (1mg, qd) or aspirin ( ≤ 100 mg per day ) is allowed
- Incomplete wound healing or fracture for long time
- Uncontrolled hypertensin with one antihypertensive agent, unstable angina, history of myocardial infarction in the past 6 months, congestive heart failure>NYHA II, serious cardiac arrhythmia
- Urinary protein≥++ and confirmed 24-hour urinary protein greater than 1.0g;
- Preexisting thyroid dysfunction, even with medical therapy, thyroid function can not be maintained in the normal range
- Uncontrolled diabetes mellitus with antidiabetic therapy
- Current peripheral neuropathy greater than CTCAE 4.0 grade 2
- Active or chronic hepatitis C and/or B infection with liver dysfunction
- History of immunodeficiency diseases, other acquired or congenital immunodeficiency diseases, or history of organ transplantation
- Serious infections requiring systemic antibiotic therapy
- Variety of factors that affect the oral medication (such as unable to swallow, chronic diarrhea, bowel obstruction and other gastrointestinal disorders or abnormalities
- Pregnancy or breast feeding
- Active alcohol or drug abuse
- Treatment in another clinical trial within the past 4 weeks before start of therapy
- Psychological, familial, sociological, or geographical factors potentially hampering compliance with the study protocol and follow-up schedule
- According to the investigator, other conditions that may increase the risk associated with patient safety and study participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SHR1020 plus Docetaxel
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SHR1020 20mg qd 2-21days, Docetaxel 60 mg/m^2 IV Day1/3weeks
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Placebo Comparator: Placebo plus Docetaxel
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Placebo matching SHR1020 qd 2-21days, Docetaxel 60 mg/m^2 IV Day1/3weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Survival
Time Frame: approximately 30 months
|
approximately 30 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression Free Survival (PFS)
Time Frame: approximately 30 months
|
approximately 30 months
|
Incidence and Intensity of Adverse Events
Time Frame: From signing informed consent document until 30 days after the last drug administration
|
From signing informed consent document until 30 days after the last drug administration
|
Objective Tumour Response (Complete Response Plus Partial Response) Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time Frame: approximately 30months
|
approximately 30months
|
Disease Control (Complete Response Plus Partial Response plus stable disease) Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time Frame: approximately 30months
|
approximately 30months
|
Quality of Life (QoL) measured by standardised questionnaires (EORTC Quality of Life Questionnaire-C30)
Time Frame: approximately 30months
|
approximately 30months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2016
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
April 18, 2016
First Submitted That Met QC Criteria
May 6, 2016
First Posted (Estimate)
May 9, 2016
Study Record Updates
Last Update Posted (Actual)
January 18, 2019
Last Update Submitted That Met QC Criteria
January 17, 2019
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
Other Study ID Numbers
- HR-FMTN-II/III-NSCLC-COM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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