Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | INDUSTRY |
| Hunan Provincial People's Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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 â…¢ study, patients who failed at least two kinds of systemic chemotherapy (third line or beyond) or drug intolerance were treated with anlotinib 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. Therefore,we envisage using anlotinib plus docetaxel treat the EGFR wild-type advanced Non-small cell lung cancer patients who were failure in the treatment of chemotherapy with platinum containing drugs, to further improve the patient's PFS or OS.
This is a multicentre randomised controlled clinical trial conducted in China to compare the effectiveness and safety of Anlotinib Plus Docetaxel in patients of EGFR wild-type Advanced Non-squamous Non-small Cell Lung Cancer.
Eligible patients will be randomized to arm A and arm B:
Arm A: Patients on the anlotinib and docetaxel arm received 75mg/m2 docetaxel as intravenous infusion on day 1 of a 21-day cycle and 12mg anlotinib orally daily on day 1to 14 of a 21-day cycle.
Arm B: Patients on the docetaxel arm received 75mg/m2 docetaxel as intravenous infusion on day 1 of a 21-day cycle.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib Plus Docetaxel | Experimental | Anlotinib (12mg QD PO d1-14, 21 days per cycle) and Docetaxel (75mg/m2 IV d1) |
|
| Docetaxel | Active Comparator | Docetaxel (75mg/m2 IV d1) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib Plus Docetaxel | Drug | Anlotinib (12mg QD PO d1-14, 21 days per cycle) and Docetaxel (75mg/m2 IV d1) |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progress free survival | each 42 days up to PD or death(up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall Survival | From randomization until death (up to 24 months) |
| ORR | Objective Response Rate | each 42 days up to intolerance the toxicity or PD (up to 24 months) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LIN WU, professor | Contact | 008613170419973 | wulin-calf@vip.163.com |
| Name | Affiliation | Role |
|---|---|---|
| LIN WU, professor | Hunan cancer hospital,Tongzipo Road 283#, Hunan,China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer hospital | Recruiting | Changsha | Hunan | 410000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40354010 | Derived | Pu X, Shou J, Xiao Z, Chen J, Xiao M, Guo Q, Ma Z, Hong W, Wang Q, Wang Y, Li J, Rao C, Weng J, Lu L, Wu L, Fang Y. Anlotinib Plus Docetaxel is Promising in Advanced NSCLC Progressing on First-Line Immunotherapy: A Pooled Analysis of Two Randomized Trials. Adv Ther. 2025 Jul;42(7):3249-3264. doi: 10.1007/s12325-025-03170-2. Epub 2025 May 12. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000625192 | anlotinib |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Docetaxel | Drug | Docetaxel (75mg/m2 IV d1) |
|
| DCR | Disease Control Rate | each 42 days up to intolerance the toxicity or PD (up to 24 months) |
| Safety (Number of Participants with Adverse Events as a Measure of Safety and Tolerability) | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Until 21 day safety follow-up visit |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |