Non Squamous NSCLC Patients With Anlotinib Combined With Pemetrexed and Cisplatin

NCT03671538 | Unknown

• 1 other identifier: ALTER-L008
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-squamous Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first

  From enrollment to completion of study. Estimated about 24 months.

Secondary Outcomes (5)

• Overall Response Rate

  From enrollment to progression of disease. Estimated about 24 months

• disease control rate

  From enrollment to progression of disease. Estimated about 24 months

• Overall Survival

  From enrollment to completion of study. Estimated about 24 months.

• 6-month PFS rate

  From enrollment to analysis, Estimated about 6 months

• 12-month PFS rate

  From enrollment to analysis. Estimated about 12 months.

Study Arms (1)

Anlotinib Plus Pemetrexed and Cisplatin

EXPERIMENTAL

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; Drug: pemetrexed; Drug: Cisplatin

Interventions

Anlotinib DRUG

Anlotinib 12mg qd on day 1 to 14 of a 21-day cycle

Anlotinib Plus Pemetrexed and Cisplatin

pemetrexed DRUG

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

Anlotinib Plus Pemetrexed and Cisplatin

Cisplatin DRUG

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

Anlotinib Plus Pemetrexed and Cisplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Lingyu Luo: lead

MeSH Terms

Interventions

anlotinib; Pemetrexed; Cisplatin

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Xiong Jian ping, MD

CONTACT

13879109229; 13879109229@163.com

Luo Ling yu, MD

CONTACT

15270855639; 15270855639@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician-in-charge

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 14, 2018
• Study Start: October 1, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2020
• Last Updated: September 17, 2018

Record last verified: 2018-09