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SHR1020 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Squamous Non Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT02766140
Recruitment Status : Terminated (difficulty in recruitment)
First Posted : May 9, 2016
Last Update Posted : January 18, 2019
Sponsor:
Collaborator:
Shanghai Pulmonary Hospital, Shanghai, China
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non Squamous Non Small Cell Lung Drug: SHR1020 plus Docetaxel Drug: Placebo plus Docetaxel Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : June 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: SHR1020 plus Docetaxel Drug: SHR1020 plus Docetaxel
SHR1020 20mg qd 2-21days, Docetaxel 60 mg/m^2 IV Day1/3weeks

Placebo Comparator: Placebo plus Docetaxel Drug: Placebo plus Docetaxel
Placebo matching SHR1020 qd 2-21days, Docetaxel 60 mg/m^2 IV Day1/3weeks




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: approximately 30 months ]

Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: approximately 30 months ]
  2. Incidence and Intensity of Adverse Events [ Time Frame: From signing informed consent document until 30 days after the last drug administration ]
  3. Objective Tumour Response (Complete Response Plus Partial Response) Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: approximately 30months ]
  4. Disease Control (Complete Response Plus Partial Response plus stable disease) Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: approximately 30months ]
  5. Quality of Life (QoL) measured by standardised questionnaires (EORTC Quality of Life Questionnaire-C30) [ Time Frame: approximately 30months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age:18-70 years
  2. 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
  3. At least one lesion that can be accurately measured and has not been received local treatments such as radiotherapy and cryotherapy
  4. Relapse or failure of one first line prior platinum-based chemotherapy
  5. Eastern Cooperative Oncology Group performance status 0 or 1
  6. Life expectancy of at least 12 weeks
  7. 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
  8. 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
  9. Patient has given written informed consent

Exclusion Criteria:

  1. More than one prior chemotherapy regimen for advanced and/or metastatic or recurrent NSCLC (except neoadjuvant or adjuvant chemotherapy )
  2. Previous therapy with other VEGFR inhibitors、recombinant human endostatin、 docetaxel or immunotherapy for treatment of NSCLC
  3. 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
  4. Have clinically significant cavity effusion,such as pleural effusion、 pericardial effusion or ascites and require clinical intervention
  5. Active brain metastases
  6. 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
  7. Significant weight loss (>10%) within the past 6 weeks
  8. Persistence of clinically relevant therapy related toxicities from previous therapy (greater than Common Terminology Criteria for Adverse Event(CTCAE) 4.0 grade 1)
  9. 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
  10. Radiographical evidence of cavitary or necrotic tumours
  11. Centrally located tumours with radiographical evidence (CT or MRI) of local invasion of major blood vessels
  12. Greater than CTCAE 4.0 grade 2 pulmonary hemorrhage within the past one month before screening
  13. History of clinically significant haemoptysis within the past 3 months (more than half a teaspoon within 24 hours )
  14. History of major thrombotic or clinically relevant major bleeding event in the past 6 months
  15. Prothrombin time (PT) and/or partial thromboplastin time (PTT) > 50% of devi

    • ation of upper limit of normal
  16. 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
  17. Incomplete wound healing or fracture for long time
  18. 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
  19. Urinary protein≥++ and confirmed 24-hour urinary protein greater than 1.0g;
  20. Preexisting thyroid dysfunction, even with medical therapy, thyroid function can not be maintained in the normal range
  21. Uncontrolled diabetes mellitus with antidiabetic therapy
  22. Current peripheral neuropathy greater than CTCAE 4.0 grade 2
  23. Active or chronic hepatitis C and/or B infection with liver dysfunction
  24. History of immunodeficiency diseases, other acquired or congenital immunodeficiency diseases, or history of organ transplantation
  25. Serious infections requiring systemic antibiotic therapy
  26. Variety of factors that affect the oral medication (such as unable to swallow, chronic diarrhea, bowel obstruction and other gastrointestinal disorders or abnormalities
  27. Pregnancy or breast feeding
  28. Active alcohol or drug abuse
  29. Treatment in another clinical trial within the past 4 weeks before start of therapy
  30. Psychological, familial, sociological, or geographical factors potentially hampering compliance with the study protocol and follow-up schedule
  31. According to the investigator, other conditions that may increase the risk associated with patient safety and study participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766140


Locations
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China, Shanghai
Shanghai Pulmonary Hospital
Shanghai, Shanghai, China, 200433
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Shanghai Pulmonary Hospital, Shanghai, China
Investigators
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Principal Investigator: caicun zhou, doctor Shanghai Pulmonary Hospital, Shanghai, China

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT02766140     History of Changes
Other Study ID Numbers: HR-FMTN-II/III-NSCLC-COM
First Posted: May 9, 2016    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: December 2018
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action