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Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer(ALTER0303) (ALTER0303)

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ClinicalTrials.gov Identifier: NCT02388919
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : September 18, 2017
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief Summary:
Evaluate the efficacy and safety of Anlotinib as the 3-line treatment of patients with advanced non-small lung cancer, with placebo control.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Anlotinib Drug: Placebo Phase 2 Phase 3

Detailed Description:
Anlotinib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration(SFDA: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 VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 439 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Registered Randomized, Double-Blind, Placebo-Controlled (2:1), Multi-Centered Clinical Trial of Anlotinib as a Treatment for Advanced Non-Small Cell Lung Cancer
Actual Study Start Date : February 26, 2015
Actual Primary Completion Date : January 5, 2017
Actual Study Completion Date : January 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Anlotinib
Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent
Drug: Anlotinib
Basic dosage, take once when limosis in the morning. If patients cannot suffer from AEs, they can get declined dosage.
Other Name: AL3818

Placebo Comparator: Placebo
Placebo p.o, qd and it should be continued until disease progress or patients withdraw consent
Drug: Placebo
Basic dosage, take once when limosis in the morning.




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From randomization until death (up to 24 months) ]

Secondary Outcome Measures :
  1. Progress free survival (PFS) [ Time Frame: each 42 days up to PD or death(up to 24 months) ]
  2. Objective Response Rate (ORR) [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]
  3. Disease Control Rate (DCR) [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]
  4. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Until 30 day safety follow-up visit ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed and dated informed consent
  2. Diagnosed with advanced NSCLC (phase IIIB/IV) through pathology, with measurable nidus(using RECIST 1.1)
  3. at least two systematic chemotherapy with upwards of 3-line treatments or cannot suffer
  4. Patients must provide detectable specimen (from tumor tissue or hydrothorax) before participating, who negative in EGFR&ALK can participate or who positive in EGFR&ALK, have or have not drug tolerance after the treatment with relative targeted drugs
  5. ECOG PS:0-1,Expected Survival Time: Over 3 months
  6. main organs function is normal
  7. The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 6 months after it

Exclusion Criteria:

  1. have used Anlotinib before
  2. Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer)
  3. examined as positive in EGFR&ALK mutation detection and never take the treatment of TKIs
  4. central lung squamous carcinoma along with cavum, or non-small cell lung cancer along with hemoptysis (>50ml/day)
  5. other kinds of malignancies within 5 years or for now
  6. plan to take systemic anti-tumor therapy within 4 weeks before grouping or during the medicine-taking period of this research, including Cytotoxic Therapy, Signal Transduction Inhibitor, and Immunotherapy (or who use Mitomycin C within 6 weeks before taking the treatment with experimental drug); The patients who have already taken Extended Field Radiotherapy (EF-RT) within 4 weeks before grouping or Limited Field Radiotherapy with proposed assessment of nidus within 2 weeks before grouping
  7. have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
  8. with kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus)
  9. pleural effusion or ascites, resulting in respiratory syndrome (≥CTC AE level 2)
  10. symptoms of brain metastases cannot be controlled and treated within less than 2 months
  11. get any severe diseases or the ones that cannot be controlled
  12. take major surgical treatments, open biopsy, or get overt traumatic injury within 28 days before grouping
  13. have any habitus or medical history of hemorrhage, however severe it is; the patients who have non healing wounds, ulcer or fracture after any events with hemorrhage or bleeding (≥CTCAE level 3)
  14. get arterial/venous thrombosis within 6 months, such as cerebrovascular accidents (including temporary ischemic stoke), deevenous thrombosis, and pulmonary embolism
  15. ever abuse psychiatric drugs and cannot abstain or who are diagnosed with mental disorder
  16. have participated in other clinical trials of anti-tumor medicine within 4 weeks
  17. diagnosed with disease which will severely endanger the security of patients or influence the completion of this research.

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): NCT02388919


  Show 40 Study Locations
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Investigators
Study Director: Baohui Han, professor Chest hospital affiliated to Shanghai jiaotong university
Study Director: Kai Lee, professor Tianjin Medical University Cancer Hospital

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT02388919     History of Changes
Other Study ID Numbers: ALTN-03-IIB
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.:
anlotinib
Cancer
NSCLC
Non-small Cell Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms