Anlotinib Combined With Docetaxel for Advanced Non-Small Cell Lung Cancer（ALTER-L034）

NCT03735264 | Unknown Phase 2

• 1 other identifier: ALTER-L034
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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 advanced non-small cell lung cancer after the failure of Platinum-Based Doublet-Chemotherapy to further improve the patient's PFS or OS.

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLC Anlotinib Docetaxel

Outcome Measures

Primary Outcomes (1)

• Progress 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.

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

Secondary Outcomes (4)

• Overall Survival (OS)

  From randomization until death (up to 24 months)

• Objective Response Rate (ORR)

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

• Disease Control Rate (DCR)

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

• Quality of Life(QoL): EORTC QLQ-C30

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

Study Arms (1)

Anlotinib Hydrochloride plus Docetaxel

EXPERIMENTAL

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

Drug: Anlotinib Hydrochloride plus Docetaxel

Interventions

Anlotinib Hydrochloride plus Docetaxel DRUG

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

Anlotinib Hydrochloride plus 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 the informed consent form prior to patient entry;
• ECOG PS：0-2;Expected Survival Time: Over 3 months;
• EGFR、ALK、ROS1 mutation-negative；Patients with squamous cell carcinoma may not have genetic testing;
• Diagnosed with advanced NSCLC (phase IIIB/IV) through pathology, with measurable nidus(using RECIST 1.1);
• Patients who has failed from the first-line Platinum-based Doublet chemotherapy with the advanced non-small cell lung cancer (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;
• Toxicity caused by prior anti-cancer treatments was restored to ≤ level 1 in CTC AE (4.0),Which accepts the interval of nitrosourea or mitomycin ≥ 6 weeks;Accept other cytotoxic drugs, anti-tumor angiogenesis therapy such as bevacizumab (Avastin), Endo, etc., surgery ≥ 4 weeks;End of radiotherapy (except for local palliative radiotherapy) ≥ 2 weeks;
• The main organs function are normally, the following criteria are met:(1)Blood routine examination criteria should be met (no blood transfusion and blood products within 14 days, no correction by G-CSF and other hematopoietic stimuli): HB≥90 g/L; ANC ≥ 1.5×10\^9/L; PLT ≥80×10\^9/L;(2)Biochemical examinations must meet the following criteria: TBIL\<1.5×ULN; ALT and AST \< 2.5×ULN, and for patients with liver metastases \< 5×ULN; Serum Cr ≤ 1.25×ULN or endogenous creatinine clearance \> 60 ml/min (Cockcroft-Gault formula);
• Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped;

You may not qualify if:

• Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer);central lung squamous carcinoma along with cavum;
• have used Anlotinib、docetaxel before;
• Imaging (CT or MRI) shows that the distance between tumor lesion and the large blood vessel is ≤ 5 mm, or there is a central tumor that invades the local large blood vessel; or there is a significant pulmonary cavity or necrotizing tumor;
• Medical history and combined history：
• Significant brain metastases, cancerous meningitis, spinal cord compression, or imaging CT or MRI screening for brain or pia mater disease (a patient with brain metastases who have completed treatment and stable symptoms in 28 days before enrollment may be enrolled, but should be confirmed by brain MRI, CT or venography evaluation as no cerebral hemorrhage symptoms);
• The patient is participating in other clinical studies or completing the previous clinical study in less than 4 weeks;
• Other active malignancies that require simultaneous treatment;
• Patients with a history of malignant tumors except for patients with cutaneous basal cell carcinoma, superficial bladder cancer, cutaneous squamous cell carcinoma or orthotopic cervical cancer who have undergone a curative treatment and have no disease recurrence within 5 years from the start of treatment;
• Patients with previous anti-tumor treatment-related adverse reactions (excluding hair loss) who have not recovered to NCI-CTCAE ≤1;
• Abnormal blood coagulation (INR \> 1.5 or prothrombin time (PT) \> ULN + 4 seconds or APTT \> 1.5 ULN), with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;Note: Under the premise of prothrombin time international normalized ratio (INR) ≤ 1.5, low-dose heparin (adult daily dose of 0.6 million to 12,000 U) or low-dose aspirin (daily dosage ≤ 100 mg) is allowed for preventive purposes;
• Renal insufficiency: urine routine indicates urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0g;
• The effects of surgery or trauma have been eliminated for less than 14 days before enrollment in subjects who have undergone major surgery or have severe trauma;
• Severe acute or chronic infections requiring systemic treatment;
• Suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval ≥ 450 ms, women ≥ 470 ms); according to NYHA criteria, grades III to IV Insufficient function, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) \<50%;
• There is currently a peripheral neuropathy of ≥CTCAE 2 degrees, except for trauma;

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

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

Central Study Contacts

Yu Zhuang, doctor

CONTACT

008618661805688; yuzhuang2002@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Anlotinib and Docetaxel

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 8, 2018
• Study Start: November 15, 2018
• Primary Completion: October 14, 2020
• Study Completion: October 15, 2020
• Last Updated: November 8, 2018

Record last verified: 2018-10