A Study of Sequential Anlotinib Followed by EP Regimen Plus Concurrent Radiotherapy for Unresectable Stage III Non-small Cell Lung Cancer

  • STATUS
    Recruiting
  • End date
    Aug 31, 2022
  • participants needed
    100
  • sponsor
    Nanfang Hospital of Southern Medical University
Updated on 23 January 2021

Summary

Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug AdministrationSFDA:2011L00661 which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2VEGFR3PDGFR and c-Kit. It has the obvious resistance to new angiogenesis. The trial is to evaluate the efficacy and safety of sequential anlotinib followed by EP regimen plus concurrent radiotherapy for unresectable stage III non-small cell lung cancer(NSCLC).

Details
Condition Unresectable Stage III Non-small Cell Lung Cancer
Treatment Anlotinib Hydrochloride
Clinical Study IdentifierNCT04111913
SponsorNanfang Hospital of Southern Medical University
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Unresectable Stage III Non-small Cell Lung Cancer??
Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure
18 and 70 years of age within male and female
Histologically confirmedlocally advanced NSCLC of stage IIIA/IIIB
Unresectable stage IIIA and stage IIIB with pathological evidence of the following images or lymph nodes
Multiple metastases of the mediastinal lymph nodes are transferred into a massive mass or multiple sites (IIIA: T1-3N2 or IIIB: T4N2)
Contralateral hilar, mediastinal lymph nodes, or the same, contralateral scalene or supraclavicular lymph node metastasis (IIIB: T1-4N3)
The lesion invades the heart, aorta and esophagus (IIIB: T4N0-1)
Life expectancy of more than 3 months
Eastern Cooperative Oncology Group(ECOG)performance scale 0-1
Weight loss 5% in the last 3 months since enrollment
Good lung function (predicted FEV1 1 liter), no history of bronchial pneumonia, tracheobronchial disease and upper respiratory tract bleeding
None previous chemotherapy or targeted therapy
Adequate hepatic, renal, heart, and hematologic functions (Absolute Neutrophil Count(ANC) 1.5109/L, Platelet (PLT) 100109/L, Hemoglobin(HB) 90 g/L, total bilirubin within 1.5the upper limit of normal(ULN), and serum transaminase2.5the Upper Limit Of Normal(ULN), serum creatine 1.25 x Upper Limit Of Normal(ULN), creatinine clearance rate 45ml/min
For women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug

Exclusion Criteria

small cell lung cancer (including small cell and non-small cell mixed lung cancer)
Radiologically documented evidence of tumor lesions from large vessels 5mm or major blood vessel invasion or encasement by cancer; Obvious cavity or necrosis formed in the tumor
History and complication
Less than 4 weeks from the last clinical trial or participating in other clinical studies
Other active malignancies that require simultaneous treatment
History of malignancy except cured basal cell skin cancer, or carcinoma in situ of the cervix, or superficial bladder cancer
Patients with previous anti-tumor treatment-related adverse reactions (excluding hair loss) did not return to NCI-CTCAE 1 level
Coagulation disfunctionINR>1.5 or PT>Upper Limit Of Normal(ULN)+4s or Activated Partial Thromboplastin Time (APTT) >1.5 Upper Limit Of Normal(ULN), hemorrhagic tendency or receiving the therapy of thrombolysis or anticoagulation
Renal insufficiency. Urine protein++, and 24h urine protein quantitation1.0g
Patients had major surgery or severe trauma before enrollment. The effects of surgery or trauma have been eliminated for less than 14 days
Severe acute or chronic infection requiring systemic treatment
Patients who suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male 450 ms, female 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association(NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)<50%
Peripheral neuropathy with CTCAE 2 degrees currently present, except for trauma
Respiratory syndrome (CTC AE grade 2 dyspnea)
Symptomatic serous effusion requiring treatment .(including hydrothorax, ascites, hydropericardium)
Long-term untreated wounds or fracturesin addition to tumor-induced pathological fractures)
Decompensated diabetes or other remedies for high-dose glucocorticoid therapy
Significant factors that influence the ingestion and absorption of medicine, (e.g. unable swallow, chronic diarrhea and intestinal obstruction
Clinically significant hemoptysis occurred within 3 months prior to enrollment (daily hemoptysis greater than 50 ml). History of clinically relevant major bleeding event=<3 months (e.g. gastrointestinal hemorrhage, Hemorrhagic acne bleeding gastric ulcer, occult blood test (++), and vasculitis
Planned systemic anti-tumor therapy, including cytotoxic therapy, signal transduction inhibitors, immunotherapy, within 4 weeks prior to enrollment in other anti-cancer drug clinical trials or within 4 weeks prior to grouping or during the study
Physical examination and laboratory inspection
Have a positive history of human immunodeficiency virus (HIV) test or have acquired immunodeficiency syndrome (AIDS)
Untreated active hepatitis (Hepatitis B: HBsAg-positive and HBV DNA 500IU/mL; Hepatitis C: HCV RNA-positive and abnormal liver function); Combined hepatitis B and C infection
At the discretion of the investigator, the patient may have other factors that may cause the study to be terminated midway, such as other serious illnesses or serious laboratory abnormalities or other safety that may affect the subject, or test data and samples. Factors such as family or society collected
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