SHR1020 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Squamous Non Small C… (NCT02766140) | Clinical Trial Compass
TerminatedPhase 3
SHR1020 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Squamous Non Small Cell Lung Cancer
Stopped: difficulty in recruitment
China12 participantsStarted 2016-06
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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
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)