Concurrent Chemoradiotherapy Combination With Anlotinib for Unresectable Stage III NSCLC Patients

September 13, 2018 updated by: Jinming Yu, Shandong Cancer Hospital and Institute

Concurrent Chemoradiotherapy Combination With Anlotinib for Unresectable Stage III NSCLC Patients:An Exploratory Single-Arm Phase II Clinical Trail

The purpose of this study is to determine whether concurrent chemoradiotherapy combination with Anlotinib is safe, effective in the treatment of unresectable stage III NSCLC patients.

Study Overview

Detailed Description

The purpose of this study is to determine whether concurrent chemoradiotherapy combination with Anlotinib is safe, effective in the treatment of unresectable stage III NSCLC patients, whether this regimen can improve PFS.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Shandong
      • Jinan, Shandong, China, 250000
        • Shandong Cancer Hospital and Institute
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients voluntarily participate in this study, signed informed consent.
  2. Patients pathologically diagnosed as locally advanced (IIIB / IV) unresectable non-small cell lung cancer, with measurable lesions; IIIa3 patient: Multiple stations lymph node metastasis detected by mediastinoscope, other lymph node biopsy or PET-CT; IIIa4 patient: Bulky or stable multiple stations N2 lymph node metastasis (Bulky lymph node: short diameter > 2cm in spiral CT imaging, especially the extranodal invasion); and IIIb patient; T3/4 patient with several ipsilateral or contralateral satellite nodules metastasis will be excluded.
  3. Detection of genotypes by providing detectable specimens (tissue) prior to enrollment: patients with negative EGFR mutation, or ALK rearrangement test results.
  4. Patients aged between 18 -75 years; with ECOG PS Scoring: 0~1 point; with expected survival time>3 months.
  5. Patients with normal organ function within 7 days prior to treatment, the following criteria are met:

    a) blood routine examination criteria (without blood transfusion in 14 days) : i) hemoglobin (HB) ≥100g/L; ii) white blood cell (WBC)≥ 3.0×10e9/L, absolute neutrophil count (ANC) ≥1.5×10e9/L; iii) platelet (PLT) ≥100×10e9/L; b) biochemical tests meet the following criteria: i) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); ii) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ULN, if liver metastasis occurred, ALT and AST ≤5 ULN; iii) serum creatinine (Cr) ≤1.5 ULN or creatinine clearance (CCr) ≥60mL/min;

  6. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥50% lower limit of normal (LLN);
  7. Lung function evaluation: forced expiratory volume in first second (FEVI)≥1.45L/s.

Exclusion Criteria(Patient meet any criteria as following will be excluded):

  1. Patients who had previously used anlotinib hydrochloride capsules;
  2. Patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer);
  3. Patients with empty lung squamous cell carcinoma, or non-small cell lung cancer with hemoptysis (>20 mL/day);
  4. Patients had other malignancies in the past 5 years or currently, except undergone resection and at least 5 years of progression free survival or cured cervical cancer in situ, basal cell carcinoma and superficial bladder tumor;
  5. Patients who planned to receive systemic anti-tumor therapy within 4 weeks prior to allocation or during the course of this study, including cytotoxic therapy, signal transduction inhibitors, immunotherapy, except the immunoregulation agents, such as thymosin and lentinan;
  6. Patients with more than common terminology criteria for adverse events (CTC AE) level 1 unmitigated toxicity due to any previous treatment, not including hair loss;
  7. Patients have a variety of factors that affect oral medication (such as cannot swallow, chronic diarrhea and intestinal obstruction, etc.);
  8. Patients with pleural effusion or ascites, causing respiratory syndrome (≥ CTC AE level 2 dyspnea);
  9. Patients with any severe and/or uncontrolled disease, including:

    1. blood pressure control is not ideal (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg);
    2. myocardial ischemic or myocardial infarction, arrhythmia (including QTc ≥480 ms) and ≥ 2 levels of congestive heart failure (NYHA classification);
    3. active or uncontrollable serious infection (≥CTC AE Level 2 infection);
    4. liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis need to be treated with antiretroviral therapy;
    5. renal failure requires hemodialysis or peritoneal dialysis;
    6. history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or history of organ transplantation;
    7. poor control of diabetes (fasting blood glucose [FBG]> 10 mmol/L);
    8. urine routine test protein≥++, and confirmed 24 hours urine protein>1.0 g;
    9. patients with a seizure and need treatment;
    10. Patients with gastric ulcer;
  10. Received a major surgical treatment within 28 days prior to allocation, with a biopsy or a significant traumatic injury;
  11. Imaging shows that the tumor has been violated around important vascular or the researchers determine the tumor is likely to invade important blood vessels caused by fatal bleeding during the follow-up;
  12. Regardless of the severity, patients with any signs or medical history of bleeding; within 4 weeks prior to allocation, patients with any bleeding events ≥ CTC AE level 3, unhealed wounds, ulcers or fractures;
  13. Patients with artery/venous thrombotic occurred within 6 months before allocation, such as cerebrovascular accident (including temporary ischemic attack),deep vein thrombosis and pulmonary embolism;
  14. Patients with a history of psychotropic medicine abuse and cannot quit or have mental disorders;
  15. Patients during pregnancy or lactation period;
  16. Patients participated in other anti-tumor drug clinical trials within 4 weeks;
  17. According to the determination of researchers, patients were diagnosed with disease which will severely endanger the security of patients or influence the completion of this research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Concurrent Chemoradiotherapy+Anlotinib
  1. Radiotherapy: Thoracic radiotherapy dose will be 2.0Gy per day, given 5 days a week, to cumulative dose of 60~66Gy. If radiotherapy and chemotherapy are conducted in the same day, chemotherapy should be priority to radiotherapy.
  2. Chemotherapy: Platinum based dual drug regime determined by researcher.After finishing concurrent chemoradiotherapy, there is no need of maintenance chemotherapy.
  3. Anlotinib: Combined with 12mg/d QD Anlotinib on the first, second weeks and fourth, fifth weeks of radiotherapy, that is on the day1~14, day22~36.
  4. Maintenance therapy: One month after finishing concurrent chemoradiotherapy, 12mg/d QD Anlotinib can be administrated, each cycle is defined as 2 weeks on-treatment followed by 1 week off-treatment. The treatment can continue until disease progression or treatment intolerance, but should not exceed 24 months.
  5. During the course of study, it's not allowed to receive other anti-tumor therapy.
Anlotinib is a novel multi-target tyrosine Kinase inhibitor that inhibits VEGFR2/3, FGFR1-4, PDGFD α/β, c-Kit and Ret.
Concurrent chemoradiotherapy as the current standard of care for unresectable stage III non small cell lung cancer patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 2 years
Progression Free Survival
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 2 years
Overall survival
2 years
DCR
Time Frame: 2 years
Disease Control Rate
2 years
ORR
Time Frame: 2 years
Objective Response Rate
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: JINMING YU, doctor, Shandong Cancer Hospital and Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2018

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

September 13, 2018

First Submitted That Met QC Criteria

September 13, 2018

First Posted (Actual)

September 14, 2018

Study Record Updates

Last Update Posted (Actual)

September 14, 2018

Last Update Submitted That Met QC Criteria

September 13, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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