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Non Squamous NSCLC Patients With Anlotinib Combined With Pemetrexed and Cisplatin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03671538
Recruitment Status : Unknown
Verified September 2018 by Lingyu Luo, The First Affiliated Hospital of Nanchang University.
Recruitment status was:  Not yet recruiting
First Posted : September 14, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Lingyu Luo, The First Affiliated Hospital of Nanchang University

Brief Summary:
Chemotherapy is still the standard first-line treatment option for EGFR unmutated patients. After a randomized phase Ⅲ trial, BEYOND was presented the synergistic effect of progression-free survival(PFS) could be expected when chemotherapy is combined with Antiangiogenesis agent bevacizumab in China;Therefore,in this study, The investigators will investigate the efficacy and safety of Anlotinb combined With Pemetrexed and Cisplatin as first-line therapy in patients with chemotherapy-naive, stage IIIB or IV, non-squamous NSCLC without targetable EGFR or ALK genetic aberrations.

Condition or disease Intervention/treatment Phase
Non-squamous Non-small Cell Lung Cancer Drug: Anlotinib Drug: pemetrexed Drug: Cisplatin Not Applicable

Detailed Description:

This is a randomized, single -center study conducted in China to compare the efficacy and safety of Anlotinb combined With Pemetrexed and Cisplatin as first-line therapy in patients of Advanced Gene Negative Non-squamous Non-small Cell Lung Cancer.

Eligible patients will be randomized to arm A:

Patients were instructed to take 500mg/m2 pemetrexed as a 10-minute intravenous infusion and Cisplatin 75mg/m2 on day 1 of a 21-day cycle and12mg Anlotinib orally daily on day 1 to 14 of a 21-day cycle.If there was no evidence of disease progression following a maximum of 4-6 cycles of anlotinib plus chemotherapy, patients continued to receive single-agent anlotinib until disease progression or unacceptable toxicity. Approximately 62 patients will be enrolled to ensure complete treatments for primary endpoint analysis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Anlotinib Combined With Pemetrexed and Cisplatin in First Treatment for Advanced Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Negative Mutations
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Anlotinib Plus Pemetrexed and Cisplatin
pemetrexed 500mg/m2 and Cisplatin 75mg/m2 on day 1 of a 21-day cycle ;Anlotinib 12mg qd on day 1 to 14 of a 21-day cycle
Drug: Anlotinib
Anlotinib 12mg qd on day 1 to 14 of a 21-day cycle

Drug: pemetrexed
pemetrexed 500mg/m2 on day 1 of a 21-day cycle ;

Drug: Cisplatin
Cisplatin 75mg/m2 on day 1 of a 21-day cycle ;




Primary Outcome Measures :
  1. progression-free survival [ Time Frame: From enrollment to completion of study. Estimated about 24 months. ]
    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first


Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: From enrollment to progression of disease. Estimated about 24 months ]
    Clinical response of treatment according to RESIST v1.1 criteria (ORR, Overall Response Rate)

  2. disease control rate [ Time Frame: From enrollment to progression of disease. Estimated about 24 months ]
    Clinical response of treatment according to RESIST v1.1 criteria (DCR, disease control rate)

  3. Overall Survival [ Time Frame: From enrollment to completion of study. Estimated about 24 months. ]
    From date of randomization until the date of death or date of last visit/contact, whichever came first

  4. 6-month PFS rate [ Time Frame: From enrollment to analysis, Estimated about 6 months ]
    Proportion of people who first documented disease progression or death from any cause, whichever came first ,during 6 months

  5. 12-month PFS rate [ Time Frame: From enrollment to analysis. Estimated about 12 months. ]
    Proportion of people who first documented disease progression or death from any cause, whichever came first ,during 12 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be≥18 years of age on the day of signing informed consent and With good compliance and agree to accept follow-up of disease progression and adverse events.
  • Patients with histologic or cytologic confirmation of advanced or metastatic Non squamous NSCLC with stage IIIB or IV disease.(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)
  • Patients have not been received systematic treatment,including chemotherapy and EGFR-TKIs
  • EGFR mutations confirmed by molecular detection (including, but not limited to, T790M, 19 exon deletion and L858R) external pathological examination was accepted (including pathological or blood test results)
  • There were at least one target lesions in the past three months has not yet accepted radiotherapy, and could be recorded by magnetic resonance imaging (MRI) or computer tomography (CT) measuring accurately at least in one direction(The maximum diameter needs to be recorded), including conventional CT ≥20 mm or spiral CT ≥10 mm.
  • Life expectancy ≥3 months.
  • Have a performance status of 0 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
  • With normal marrow, liver ,renal and coagulation function:
  • 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)≥1.5×109/L
  • A Platelet count of (PLT)≥80×109/L
  • A total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL)
  • A alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) 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)
  • Doppler echocardiography: left ventricular ejection fraction (LVEF) is lower than normal (50%)
  • Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 8 weeks after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug.

Exclusion Criteria:

  • Small cell lung cancer (include Small cell lung cancer mixture of NSCLC)
  • 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 Other active malignant tumors requiring concurrent treatment;
  • Patients has a history of malignant tumors. Patients with basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma, or cervical cancer in situ who have undergone possible curative treatment and have not suffered any recurrence of the disease within 5 years from the start of treatment
  • Patients with brain or central nervous system metastases, including leptomeningeal disease, or CT/MRI examination revealed brain or leptomeningeal disease) (14 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 who have not recovered to grade 1 or below according to NCI-CTCAE4.0 after previous systemic antitumor therapy (except alopecia)
  • Uncontrollable hypertensive (systolic blood pressure or greater 140 mmHg or diastolic blood pressure or greater 90 mmHg, despite the best drug treatment)
  • Patients with NCI-CTCAE grade II or greater peripheral neuropathy, except due to trauma
  • 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%
  • 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. 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.
  • Urine routines show urine protein≥ ++, or urine protein quantity≥ 1.0 g during 24 hours
  • Patients with severe infections , and need to receive systemic antibiotic treatment.(according to the CTC AE4.0, the infection with grade 2 or above and requiring intravenous antibacterial therapy );Decompensated diabetes or other contraindication with high dose glucocorticoid therapy)
  • Patients with respiratory syndrome (difficulty breathing of level 2 or higher according to the CTC AE), serous cavity effusion need to surgical treatment (according to the CTC AE4.0, including pleural of level 2 or higher with respiratory distress and anoxia, need for intubation or pleurodesis treatment, severe ascites of level 2 need to surgery invasive treatment, pericardial of level 2 and affect physiological function)
  • Serious, non-healing wound, ulcer, or bone fracture
  • Active or chronic hepatitis c and/or Hepatitis B virus (HBV) infection
  • Has an obvious factor influencing oral drug absorption, such as unable to swallow, chronic diarrhea and intestinal obstruction, etc
  • Has received major surgery or severe traumatic injury, fractures or ulcer Within 4weeks before Random
  • Patients have participated in other antitumor drug clinical trials Within 4 weeks before enrollment or prepare to receive systemic anti-tumor treatment during the study or Within 4 weeks before randomization, including cytotoxic therapy cellular, Signal transduction inhibitors, immune therapy (or receiving mitomycin C Within six weeks before taking experimental drug therapy).Field overspread radiotherapy (ef-rt) was carried out within 4 weeks before the grouping or limited field radiotherapy was carried out within 2 weeks before the grouping to evaluate tumor lesions
  • Severe weight loss (> 10%) Within 6 weeks before Random
  • Has Clinically significant hemoptysis Within 3 months before Random (daily hemoptysis than 50 ml;Or significant clinical significance of bleeding symptoms or have definite bleeding tendency, such as gastrointestinal bleeding, bleeding ulcers, baseline period + + and above of fecal occult blood, or vasculitis, etc
  • Has venous thromboembolism events Within 12 months before Random, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.
  • Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671538


Contacts
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Contact: Xiong Jian ping, MD 13879109229 13879109229@163.com
Contact: Luo Ling yu, MD 15270855639 15270855639@163.com

Sponsors and Collaborators
Lingyu Luo
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Responsible Party: Lingyu Luo, Physician-in-charge, The First Affiliated Hospital of Nanchang University
ClinicalTrials.gov Identifier: NCT03671538    
Other Study ID Numbers: ALTER-L008
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors