Anlotinib Plus Docetaxel for the Treatment of EGFR Wild-type Advanced Non-small-cell Lung Cancer

NCT03624309 | Unknown Phase 2

• 1 other identifier: ALTER-L018
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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 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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  Progress free survival

  each 42 days up to PD or death(up to 24 months)

Secondary Outcomes (4)

• OS

  From randomization until death (up to 24 months)

• ORR

  each 42 days up to intolerance the toxicity or PD (up to 24 months)

• DCR

  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)

  Until 21 day safety follow-up visit

Study Arms (2)

Anlotinib Plus Docetaxel

EXPERIMENTAL

Anlotinib (12mg QD PO d1-14, 21 days per cycle) and Docetaxel (75mg/m2 IV d1)

Drug: Anlotinib Plus Docetaxel

Docetaxel

ACTIVE COMPARATOR

Docetaxel (75mg/m2 IV d1)

Drug: Docetaxel

Interventions

Anlotinib Plus Docetaxel DRUG

Anlotinib (12mg QD PO d1-14, 21 days per cycle) and Docetaxel (75mg/m2 IV d1)

Also known as: Anlotinib & Docetaxel

Anlotinib Plus Docetaxel

Docetaxel DRUG

Docetaxel (75mg/m2 IV d1)

Docetaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• signed and dated informed consent
• diagnosed with advanced NSCLC (phase IIIB/IIIC/IV) through pathology, with measurable nidus(using RECIST 1.1)
• have failed for platinum two drugs chemotherapy
• EGFR wild type
• ECOG PS：0-1,Expected Survival Time: Over 3 months
• main organs function is normal
• 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 2 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 2 months after it

You may not qualify if:

• Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer)
• have used docetaxel before
• have used antiangiogenic drugs （except Bevacizumab or endostatin）
• have failed for two times or beyond of platinum two drugs chemotherapy（except adjunctive therapy，neoadjuvant therapy and concurrent chemoradiotherapy ）
• iconography (CT or MRI) shows that the tumor vessels have 5 mm or less, or Cardiovascular involvement by Central tumor ; Or obvious lung empty or necrotic tumor
• patients with brain or central nervous system metastases, including leptomeningeal disease, or CT/MRI examination revealed brain or leptomeningeal disease） (28 days before the random treatment has been completed and the symptoms of patients with brain metastases from stable can into the group, but need to the cerebral MRI, CT or vein angiography confirmed as without symptoms of cerebral hemorrhage)
• patients are participating in other clinical studies (other than non-interventional studies) less than 4 weeks from the end of a previous clinical study
• other kinds of malignancies within 5 years or for now
• have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
• abnormal coagulation (INR \> 1.5 or prothrombin time (PT) \> ULN + 4 seconds or APTT ULN \> 1.5), with bleeding tendency or be treated with thrombolysis and anticoagulation
• urine routines show urine protein≥ ++, or urine protein quantity≥ 1.0 g during 24 hours
• uncontrollable hypertensive (systolic blood pressure or greater 150 mmHg or diastolic blood pressure or greater 90 mmHg, despite the best drug treatment)
• the effects of surgery or trauma had been eliminated for less than 14 days before admission to the study group
• patients with severe infections , and need to receive Systemic antibiotic treatment
• significant cardiac disease as defined as: grade II or greater myocardial infarction, unstable arrhythmia(Including corrected QT interval (QTc )period between male or greater 450 ms, female or greater 470 ms); New York Heart Association (NYHA) grade II or greater heart dysfunction , or Echocardiography reveal left ventricular ejection fraction （LVEF）Less than 50%

Sponsors & Collaborators

• Hunan Cancer Hospital: lead
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator
• Hunan Provincial People's Hospital: collaborator

Study Sites (1)

Hunan Cancer hospital

Changsha, Hunan, 410000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40354010 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

anlotinib; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• LIN WU, professor

  Hunan cancer hospital,Tongzipo Road 283#, Hunan,China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LIN WU, professor

CONTACT

008613170419973; wulin-calf@vip.163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief director of department

Study Record Dates

• First Submitted: August 5, 2018
• First Posted: August 10, 2018
• Study Start: October 15, 2018
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

CN (1)