Condition or disease | Intervention/treatment | Phase |
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NSCLC | Drug: Anlotinib Hydrochloride | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Safety and Efficacy of Anlotinib Hydrochloride Combined With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR TKIs) in Treating Advanced Non-small-cell Lung Cancer (NSCLC) Patients With Acquired Resistance to EGFR TKIs |
Estimated Study Start Date : | July 2019 |
Estimated Primary Completion Date : | July 2021 |
Estimated Study Completion Date : | December 2021 |
Arm | Intervention/treatment |
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Experimental: Anlotinib Hydrochloride combined with EGFR-TKI
Patients receive anlotinib (12 mg orally daily for 14 days every 21 days cycle) combined with one of following EGFR-TKIs: Gefitinib is administered 250 mg once per day. Erlotinib is administered 150 mg once per day , or Icotinib is administered 125 mg three times per day, until disease progression or untolerated toxicity.
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Drug: Anlotinib Hydrochloride
anlotinib (12 mg orally daily for 14 days every 21 days cycle) combined with one of EGFR-TKIs
Other Names:
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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 |
Inclusion Criteria:
Patients should be using the EGFR TKI monotherapy as the first line treatment and meet the following criteria:
Patients who showed objective clinical benefit from treatment with an EGFR
TKI as defined by either:
Patients who showed 1. risk of recurrence and progression, 2. gradual progression or local progression while on continuous treatment with EGFR TKI within the last 28 days prior to enrollment.( For recurrent diseases, patients can be accepted with adjuvant chemotherapy, neoadjuvant chemotherapy or neoadjuvant chemotherapy plus adjuvant chemotherapy in the past, and 3. relapse occurs 6 months after the end of treatment).
The main organs function meet following criteria:
Exclusion Criteria:
Contact: HUAJUN CHEN, MD | 0086-13710581145 | chjdoctor@163.com |
China, Guangdong | |
Guangdong General Hospital | |
Guangzhou, Guangdong, China, 510080 | |
Contact: HUAJUN CHEN, MD | |
Principal Investigator: HUAJUN CHEN, MD |
Study Chair: | Yi-Long Wu, MD | Guangdong General Hospital (GGH)& Guangdong Academy of Medical Sciences | |
Study Director: | HUAJUN CHEN, MD | Guangdong Provincial People's Hospital |
Tracking Information | |||||||
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First Submitted Date ICMJE | June 25, 2019 | ||||||
First Posted Date ICMJE | July 5, 2019 | ||||||
Last Update Posted Date | July 5, 2019 | ||||||
Estimated Study Start Date ICMJE | July 2019 | ||||||
Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Progression free survival(PFS) [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs earlier, assessed up to 1 year ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | No Changes Posted | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Anlotinib Hydrochloride Combined With EGFR-Tyrosine Kinase Inhibitor (TKI) in Treating Advanced NSCLC Patients With Acquired Resistance to EGFR-TKI | ||||||
Official Title ICMJE | Safety and Efficacy of Anlotinib Hydrochloride Combined With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR TKIs) in Treating Advanced Non-small-cell Lung Cancer (NSCLC) Patients With Acquired Resistance to EGFR TKIs | ||||||
Brief Summary | The Single-arm, multicenter study evaluate the safety and efficacy of Anlotinib Hydrochloride combined with EGFR TKIs in treating Advanced NSCLC With acquired Resistance to EGFR TKIs | ||||||
Detailed Description | EGFR TKI have been approved as first-line treatment in NSCLC patients harboring EGFR mutation. However, the acquired resistance of EGFR-TKI occurs almost constantly. Anlotinib is a novel oral multitarget tyrosine kinase inhibitor and primary targeted to Vascular Endothelial Growth Factor Receptor (VEGFR), fibroblast growth factor receptor (FGFR) , platelet-derived growth factor receptor (PDGFR) and c-Kit. The ALTER-0303 trial showed that patients with advanced non-small cell lung cancer (NSCLC) who received anlotinib as third-line or further therapy had more survival benefit. The Single-arm, multicenter study evaluate the safety and efficacy of Anlotinib Hydrochloride combined with EGFR TKIs in treating Advanced NSCLC With acquired Resistance to EGFR TKIs | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | NSCLC | ||||||
Intervention ICMJE | Drug: Anlotinib Hydrochloride
anlotinib (12 mg orally daily for 14 days every 21 days cycle) combined with one of EGFR-TKIs
Other Names:
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Study Arms ICMJE | Experimental: Anlotinib Hydrochloride combined with EGFR-TKI
Patients receive anlotinib (12 mg orally daily for 14 days every 21 days cycle) combined with one of following EGFR-TKIs: Gefitinib is administered 250 mg once per day. Erlotinib is administered 150 mg once per day , or Icotinib is administered 125 mg three times per day, until disease progression or untolerated toxicity.
Intervention: Drug: Anlotinib Hydrochloride
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||
Estimated Enrollment ICMJE |
120 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | December 2021 | ||||||
Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04007835 | ||||||
Other Study ID Numbers ICMJE | CTONG1803 | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Guangdong Association of Clinical Trials | ||||||
Study Sponsor ICMJE | Guangdong Association of Clinical Trials | ||||||
Collaborators ICMJE | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | ||||||
Investigators ICMJE |
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PRS Account | Guangdong Association of Clinical Trials | ||||||
Verification Date | July 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |