Anlotinib Combined With Docetaxel Versus Docetaxel for Previous Treated Advanced NSCLC (ACWDVDFPTAN)
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|ClinicalTrials.gov Identifier: NCT03726736|
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : June 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Anlotinib combined Docetaxel Drug: Docetaxel||Phase 1 Phase 2|
This multicentre randomised controlled clinical trial conducted in China include phase I study and phase II study.
Phase I study: to get the maximum tolerated dose of anlotinib when combined with Docetaxel.
Phase II study: to compare the effectiveness and safety of Anlotinib Plus Docetaxel in patients of EGFR wild-type Advanced Non-squamous Non-small Cell Lung Cancer.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||97 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Anlotinib Combined With Docetaxel Versus Docetaxel for Platinum-based Therapy Treated Advanced NSCLC: a Multicentre, Randomised Explorative Trial|
|Actual Study Start Date :||December 21, 2018|
|Estimated Primary Completion Date :||November 1, 2019|
|Estimated Study Completion Date :||November 1, 2020|
Experimental: Anlotinib combined Docetaxel
patients treated with anlotinib and Docetaxel (21 days for 1 cycle) until PD (progressive disease)
Drug: Anlotinib combined Docetaxel
Anlotinib ( dose base on phase I study, QD PO d1-14, 21 days per cycle) and Docetaxel (60mg/m2 IV, d1, 21 days per cycle)
Active Comparator: Docetaxel
patients treated with Docetaxel (21 days for 1 cycle) until PD (progressive disease)
Docetaxel (60mg/m2 IV, d1, 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
- quality of life [ 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
- ORR [ 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
- 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): NCT03726736
|Sir Run Run Shaw Hospital||Recruiting|
|Hangzhou, Zhejiang, China, 310000|
|Contact: Hongming Pan, MD （86）571 86006926 firstname.lastname@example.org|
|Sub-Investigator: Yong Fang, MD|