Anlotinib Hydrochloride as Second-line Therapy in Elderly Patients With EGFR Wild-type Lung Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT03728374|
Recruitment Status : Unknown
Verified October 2018 by Hanyan Xu, First Affiliated Hospital of Wenzhou Medical University.
Recruitment status was: Not yet recruiting
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
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 cell proliferation 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. Subgroup analysis results suggest that elderly patients may get longer mPFS and mOS.
Therefore, the investigators envisage an open, single-arm, single-center clinical trial using anlotinib in elderly patients with EGFR wild-type lung adenocarcinoma who refused chemotherapy, to find if anlotinib is a better option in NSCLC second-line therapy.
|Condition or disease||Intervention/treatment||Phase|
|Non-Small-Cell Lung Cancer||Drug: Anlotinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Anlotinib Hydrochloride as Second-line Therapy in Elderly Patients With EGFR Wild-type Lung Adenocarcinoma Who Refused Chemotherapy: an Open, Single-arm, Single-center Clinical Trial|
|Estimated Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||November 1, 2019|
|Estimated Study Completion Date :||November 1, 2020|
Anlotinib ( 12mg, QD, PO, d1-14, 21 days per cycle)
- PFS [ Time Frame: each 42 days up to PD or death(up to 24 months) ]Progress free survival
- OS [ Time Frame: From randomization until death (up to 24 months) ]Overall Survival
- ORR [ Time Frame: Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]Objective Response Rate
- DCR [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]Disease Control Rate
- QoL: EORTC QLQ-C30 [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]use EORTC QLQ-C30(version 3) questionnaire to evaluate the quality of life
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Until 21 day safety follow-up visit ]Record Adverse Events (AEs) according to CTCAE (V4.03). To find Potential adverse reaction, measure blood pressure at least 2 times a week and test blood routine, Blood biochemical, Urine routine, stool routine, coagulation function, electrocardiogram for each follow-up, record and analyze the number of abnormal data.
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): NCT03728374
|Contact: Yuping Li, doctor||86 email@example.com|
|Study Chair:||Yuping Li, doctor||First Affiliated Hospital of Wenzhou Medical University|