A Study of Anlotinib in Combination With Docetaxel Versus Docetaxel Alone in Participants With Advanced NSCLC

NCT03732001 | Unknown Phase 2

• 1 other identifier: ALTER-L024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the efficacy and safety of Anlotinib in combination with Docetaxel versus Docetaxel in patients with advanced non-small lung cancer after failure of first-line Chemotherapy .

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 and Tolerability: Number of Participants with Adverse Events

  Until 30 day safety follow-up visit

Study Arms (2)

Anlotinib combined Docetaxel

EXPERIMENTAL

patients treated with Anlotinib and Docetaxel (21 days for 1 cycle) until disease progress or toxicity cannot be tolerated or patients withdraw consent

Drug: Anlotinib combined Docetaxel

Docetaxel

ACTIVE COMPARATOR

patients treated with Docetaxel (21 days for 1 cycle) until disease progress or toxicity cannot be tolerated or patients withdraw consent

Drug: Docetaxel

Interventions

Anlotinib combined Docetaxel DRUG

Anlotinib ( 12mg, QD, PO d1-14, 21 days per cycle) and Docetaxel (60mg/m2, IV, d1, 21 days per cycle)

Anlotinib combined Docetaxel

Docetaxel DRUG

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

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:

• Diagnosed as non-small cell lung adenocarcinoma (NSCLC) by cytology or histology; diagnosed as stage IIIB, IIIC or IV according to the 2017 new version of the UICC lung cancer staging criteria (8th edition);Note:Patients with stage IIIB and IIIC must be at least one measurable lesion in patients who cannot be surgically resected;
• Patients who negative in EGFR\&ALK can participate after systematic chemotherapy treatments or cannot suffer，and no Docetaxel before;Patients who positive in EGFR\&ALK, must have treatment with relative targeted drugs，then after systematic chemotherapy treatments or cannot suffer，and no Docetaxel before；
• \. Age 18-75 years old, Female or Male；
• \. PS 0-1 points（ECOG）;
• \. Life expectancy is at least 3 months;
• \. At least one target lesion that has not received radiotherapy in the past 3 months, and accurate measurement by magnetic resonance imaging (MRI) or computed tomography (CT) in at least 1 direction,target lesion maximum diameter required to be recorded ≥ 10 mm (lymphaden minimum diameter must ≥ 15 mm can be regard as target lesion );
• 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 3 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 72 hours before the research; The man patients who must agree to take contraceptive methods during the research and within another 3 months after it;
• The main organs function are normally, the following criteria are met:
• Blood routine examination must meet the following criteria:
• ANC ≥ 1.5×10\^9/L;PLT ≥90×10\^9/L; HB≥90 g/L;
• 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 ≤ 1.5×ULN or endogenous creatinine clearance \> 50 ml/min
• LVEF≥50%;
• QTcF\<450ms(male),QTcF\<470ms（female）;
• Signed and dated informed consent;

You may not qualify if:

• have used Anlotinib 、Docetaxel before；
• Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer);
• 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;
• History and comorbidities
• Active 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 14 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;
• Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg，diastolic pressure≥100 mmHg);
• 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;
• Have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included;
• 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

• China Medical University, China: lead
• Shengjing Hospital: collaborator
• The Second Affiliated Hospital of Dalian Medical University: collaborator
• General Hospital of Shenyang Military Region: collaborator
• The People's Hospital of Liaoning Province: collaborator
• Shenyang Chest Hospital: collaborator
• Anshan Tumor Hospital: collaborator
• Affiliated Zhongshan Hospital of Dalian University: collaborator
• The First People's Hospital of Jingzhou: collaborator
• Benxi Cental Hospital: collaborator
• Panjin Liaohe Oilfield Gem Flower Hospital: collaborator
• Panjin Central Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

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

Study Officials

• Yunpeng Liu, PhD

  China Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiujuan Qu, PhD

CONTACT

024-83282542; qu_xiujuan@hotmail.com

Bo Jin, PhD

CONTACT

024-83282542; jb_cmu@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Medical Oncology,The First Hospital of China Medical University

Study Record Dates

• First Submitted: November 4, 2018
• First Posted: November 6, 2018
• Study Start: November 8, 2018
• Primary Completion: November 9, 2019
• Study Completion: November 9, 2020
• Last Updated: November 28, 2018

Record last verified: 2018-11

Locations

CN (1)