Study of Anlotinib in Non-squamous NSCLC Patients Who Failed First-Line(ALTER-L020)

Last updated: April 1, 2020
Sponsor: First Affiliated Hospital Xi'an Jiaotong University
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03755869
XJTU1AF2018LSK-073
  • Ages 18-75
  • All Genders

Study Summary

Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor celltebiz related kinase -c-Kit kinase. In the phase III study, Patients who failed at least two kinds of systemic chemotherapy (third line or beyond) or drug intolerance were treated with anlotinib (12mg, po. qd. on day 1to14 of a 21-day cycle) or placebo, the anlotinib group PFS and OS were 5.37 months and 9.63 months, the placebo group PFS and OS were 1.4 months and 6.3 months.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed and dated informed consent

  • Age:18~75 years;

  • Subjects with histologically or cytologically confirmed locally advanced and/oradvanced NSCLC

  • at least two systematic chemotherapy with upwards of 1-line treatments or cannotsuffer

  • The negative patients in EGFR&ALK can participate or who positive in EGFR&ALK, have orhave not drug tolerance after the treatment with relative targeted drugs

  • Subjects with at least one measurable lesion as defined by RECIST (version 1.1)

  • Expected Survival Time: Over 3 months

  • ECOG PS:0-1,

  • main organs function is normal

  • The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research andwithin another 6 months after it; who are not in the lactation period and examined asnegative in blood serum test or urine pregnancy test within 7 days before theresearch; The man patients who must agree to take contraceptive methods during theresearch and within another 6 months after it

Exclusion

Exclusion Criteria:

  • 1.Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixedwith non-small cell cancer)

  • lung squamous carcinoma

  • Other active malignancies requiring treatment

  • History of malignancy

  • Have got non remissive toxic reactions derived from previous therapies, which is overlevel 1 in CTC AE (4.0), alopecia NOT included

  • Abnormal coagulation (INR>1.5 or PT>ULN+4s or APTT >1.5 ULN); Patients with anyphysical signs of bleeding diathesis or receiving thrombolysis and anticoagulation

  • take major surgical treatments or have serious trauma before grouping, or the impactof surgery or trauma has been eliminated for less than 14 days.

  • Patients with active or unable to control serious infections;

  • Patients with Grade II or higher myocardial ischemia, myocardial infarction ormalignant arrhythmias(including QTc male ≥ 450 ms, female ≥ 470 ms) ; Patients withgrade III to IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) <50% (NYHA Classification)

  • Patients with non-healing wounds or fractures

  • with kinds of factors which affect oral medicine (e.g. failing to swallow,gastrointestinal tract getting resected, chronic diarrhea and ileus).

  • get arterial/venous thrombosis within 12 months, such as cerebrovascular accidents (including temporary ischemic stoke), deevenous thrombosis, and pulmonary embolism

  • plan to take systemic anti-tumor therapy within 4 weeks before grouping or during themedicine-taking period of this research, including Cytotoxic Therapy, SignalTransduction Inhibitor, and Immunotherapy

  • Patients with cirrhosis, decompensated liver disease, or active hepatitis Havesuffered from hemorrhagic disease or coagulation dysfunction

  • diagnosed with disease which will severely endanger the security of patients orinfluence the completion of this research

Study Design

Total Participants: 103
Study Start date:
November 29, 2018
Estimated Completion Date:
December 31, 2021

Study Description

It is an open, single-arm, multi-center clinical trial conducted in China, and plan to Recruiting103 patients who were progressed after first line systemic therapy and refused/can't tolerate chemotherapy. Patents receive 12mg anlotinib orally daily on day 1to 14 of a 21-day cycle until progression of disease, assess safety and efficacy of the drug.

Connect with a study center

  • Shaanxi Provincial Cancer Hospital

    Xian, Shanxi 710000
    China

    Active - Recruiting

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