Anlotinib Versus Docetaxel as the Second-line Treatment in EGFR Wild Type Patients With Advanced NSCLC

NCT03703596 | Unknown Phase 2

• 1 other identifier: ALTER-L023
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 10

Brief Summary

This study is conducted to explore the safety and efficacy of anlotinib, a tyrosine kinase inhibitors of Vascular Endothelial Growth Factor Receptor 2（VEGFR）、FGFR（Fibroblast Growth Factor Receptor）, Platelet-derived growth factor Receptor（PDGFR） and c-kit, vs docetaxel in advanced Non-squamous Non-small cell lung cancer harbouring wild-type epidermal growth factor receptor (EGFR) .

Conditions

Lung Cancer; Lung Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.

  Up to 24 months

Secondary Outcomes (2)

• Objective response rate(ORR)

  Up to 24 months

• Disease Control Rate (DCR)

  Up to 24 months

Study Arms (2)

Anlotinib hydrochloric

EXPERIMENTAL

Anlotinib (12mg QD PO d1-14, 21 days per cycle)

Drug: Anlotinib Hydrochloride

Docetaxel

EXPERIMENTAL

Docetaxel (75mg/m2 IV d1, 21 days per cycle)

Drug: Docetaxel

Interventions

Anlotinib Hydrochloride DRUG

Anlotinib (12mg QD PO d1-14, 21 days per cycle)

Anlotinib hydrochloric

Docetaxel DRUG

Docetaxel (75mg/m2 IV d1, 21 days per cycle)

Docetaxel

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 and ≤ 70 years of age. Signed the informed consent form prior to patient entry
• Histologically or pathologically confirmed non-squamous non-small cell lung cancer(NSCLC) with stage IV .
• Histologically or pathologically confirmed non-squamous non-small cell lung cancer(NSCLC) with stage IV .
• Patients who has failed from the first-line Platinum-based Doublet chemotherapy harbouring epidermal growth factor receptor(EGFR) sensitive mutations negetive, confirmed by pathological or blood test results) ）,ALK/ROS1 mutation-negative or unknown (For recurrent patients, adjuvant chemotherapy, neoadjuvant chemotherapy or neoadjuvant chemotherapy plus adjuvant were assessed for eligibility, and the last treatment time must be more than 6 months before enrollment） Noted: failed from prior treatment means(1) progress disease confirmed by CT; cannot tolerable from standard treatment, such as hematologic toxicities ≥ level 4; non-hematologic toxicities ≥ level 3;damages of heart/liver/kidney ≥ level 2 in CTC AE 4.0
• Must have at least one measurable lesion as per RECIST 1.1 defined as a lesion that is 10mm in longest diameter imaged by CT scan or MRI；prior topical treatment, such as radiotherapy cryosurgery to the lesions is not allowed in less than 3 months;
• Life expectancy ≥3 months.
• Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
• Toxicity caused by prior anti-cancer treatments was restored to ≤ level 1 in CTC AE (4.0) , except alopecia;
• The blood routine examination need to be standard (no blood transfusion and blood products within 14 days, no g-csf and other hematopoietic stimulating factor correction); Hemoglobin（HB）≥90 g/L; A Neutrophil count of （ANC）≥1.5×10e9/L; A Platelet count of （PLT）≥80×10e9/L; A Total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); A alanine aminotransferase (ALT) and a aspartate aminotransferase (AST) of ≤2.5 UNL, in case of liver metastasis ALAT and ASAT≤5 UNL; A creatinine (Cr) of ≤1.5 UNL; a creatinine clearance rate ≥ 60ml/min (Cockcroft-Gault);
• The woman patients of childbearing age who must agree to take contraceptive methods during the research and within another 8 weeks after it 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 8 weeks Voluntarily joined the study and signed informed consent, with good compliance and follow-up.

You may not qualify if:

• Mixed Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer, adenocarcinoma mixed with squamous cell carcinoma
• No squamous NSCLC with hemoptysis (\>50ml/day);
• Treated by taxel or similar drugs in 12months;
• symptoms of brain metastases cannot be controlled and treated within less than 2 months
• Tumor locate within a distance of less than 5 mm from the large vessels, less than 2 cm from the bronchial tree, or has invaded local large vessels; tumor with cavum or necrotic obviously;
• Uncontrolled hypertension (systolic ≥140mmHg and/or diastolic ≥90mmHg, despite optimal drug therapy).
• Patients with with grade Ⅱ myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male ≥ 450 ms, female ≥470 ms); according to NYHA standard, grade Ⅲ \~ Ⅳ heart failure, or cardiac color Doppler ultrasound examination showed left ventricular ejection fraction (LVEF) \<50%.
• Coagulation dysfunction (INR\> 1.5, PT\> ULN +4s or APTT\> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment;note: Note: under the premise of International Normalized ratio (INR) of prothrombin time (PT) Less than or equal to 1.5, allow to administrate low-dose heparin (adult daily dose is 06000 \~ 12000 U) or low-dose aspirin (100 mg daily dosage or less) , for prophylactic purposes
• Patients whose routine urine tests indicate that urine protein ≥ ++ or verifies that the 24-h urine protein quantitation ≥ 1.0 g.
• Patients whose has peripheral neuropathy over level 2 in CTC AE4.0, except trauma.
• Patients with respiratory syndrome (difficulty breathing of level 2 or higher ), serous cavity effusion need to surgical treatment ( including pleural of level 2 or higher with respiratory distress and anoxia
• Patients who have unhealed wounds or fractures for a long time.
• Patients with severe infections , and need to receive systemic antibiotic treatment
• Decompensated diabetes or other contraindication with high dose glucocorticoid therapy;
• Cirrhosis or decompensated liver disease; active or untreated hepatitis C and/or Hepatitis B virus (HBV) infection（prior hepatitis B history, HBsAg positive and HBV DNA≥500IU/mL; HCV RNA positive and hepatic Insufficiency

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (10)

People's hospital of deyang city

Deyang, Sichuan, China

Location

Chengdu fifth people's hospital

Chengdu, China

Location

Sichuan cancer hospital

Chengdu, China

Location

People's hospital of guangan city

Guangan, China

Location

The affiliated hospital of southwest medical university

Luzhou, China

Location

Nanchong central hospital

Nanchong, China

Location

Neijing second people's hospital

Neijiang, China

Location

Suning central hospital

Suning, China

Location

Zigong first people's hospital

Zigong, China

Location

Zigong fourth people's hospital

Zigong, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

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

• Wenxiu Yao, PhD

  Director of Medical Oncology Thoracic Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenxiu Yao, PhD

CONTACT

+8618908178836; ywxhlx@sina.com

Jianning Tang

CONTACT

+8618328581906

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: assistant of Medical Oncology Thoracic Department

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: October 12, 2018
• Study Start: October 16, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2020
• Last Updated: October 12, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)