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

Hengrui Medicine

Status and phase

Terminated

Phase 3

Conditions

Non Squamous Non Small Cell Lung

Treatments

Drug: Placebo plus Docetaxel

Drug: SHR1020 plus Docetaxel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02766140

HR-FMTN-II/III-NSCLC-COM

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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