Study of Apatinib as the Maintenance Therapy in Advanced Lung Adenocarcinoma

A Single-Arm Phase II Clinical Trial of Apatinib as the Maintenance Therapy in Advanced Lung Adenocarcinoma

The purpose of this study is to confirm the safety and efficacy of Apatinib plus Pemetrexed as the Maintenance Therapy in Advanced Lung Adenocarcinoma.

Study Overview

• Status: Unknown
• Conditions: Lung Adenocarcinoma
• Intervention / Treatment: Drug: Apatinib

Detailed Description

Lung adenocarcinoma is the most common NSCLC,most patient were diagnosed to advanced stage. Maintenance treatment is the continuation of treatment after first-line treatment and before the disease progresses. We consider to add apatinib,a tyrosine kinase inhibitor of VEGF,to the therapy of these patients. We designed the study to explore the possibility of apatinib for maintenance.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Recruiting
      • Henan Cancer Hospital
      • Contact: Guowei Zhang; Email: dugu4986@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Histologically or cytologically confirmed of lung adenocarcinoma, EGFR wild-type or known drug-resistant mutation, stage IV or irradiative stage IIIB.
2. Age ≥ 18 years;
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1;
4. Patients had previously received at least 4 cycles of first-line, double chemotherapy and had no disease progression at baseline screening compared with baseline imaging prior to first-line chemotherapy；
5. Adequate hepatic, renal, heart, and hematologic functions: ANC ≥ 1.5×109/L, PLT ≥ 100×109/L, HB ≥ 90 g/L, TBIL ≤ 1.5×ULN, ALT or AST ≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Serum Cr ≤ 1×ULN, Cr clearance ≥ 45 mL/min;

Exclusion Criteria:

1. Active brain metastases, meningococcal meningitis, patients with spinal cord compression, or imaging at CT or MRI examination revealed brain or pia mater disease（Patients who have completed treatment and whose symptoms are stable in the first 21 days of randomization may be enrolled in the study but may be diagnosed as having no intracerebral hemorrhage by MRI, CT or venography）；
2. Imaging (CT or MRI) showed that the tumor lesions were ≤ 5 mm from the major vessels or there was a central tumor invading local macrovascular；
3. Imaging (CT or MRI) showed significant cavitary or necrotic lung tumors, uncontrollable hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, despite optimal medical therapy), grade II The above myocardial ischemia or myocardial infarction, poor control of arrhythmia (including QTc interval male ≥ 450 ms, female ≥ 470 ms); NYHA standards, Ⅲ ~ Ⅳ grade cardiac insufficiency, or cardiac ultrasound examination prompted left ventricular ejection Score (LVEF) <50%；
4. Coagulation dysfunction (INR> 1.5, PT> ULN +4s or APTT> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment；Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or the like；
5. Patients who had obvious hemoptysis within 2 months before screening, or experienced daily hemoptysis with a volume more than half a tea spoon (2.5ml) or above；
6. Patients who experienced bleeding symptoms of clinical significance within 3 months before screening, or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc.
7. Patients who manifested arterial/venous thrombus events, e.g. cerebrovascular accident (Including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening（Such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism and so on）；
8. Patients whose routine urine tests indicate that urine protein ≥ ++ or verifies that the 24-h urine protein quantitation ≥ 1.0 g；
9. Confirmed ALK gene fusion；
10. Anti-angiogenic drugs were used during first-line chemotherapy。

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apatinib + Pemetrexed	Drug: Apatinib; Apatinib (250 mg/d) + Pemetrexed (500 mg/m2); Other Names: Pemetrexed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	From date of randomization until the date of first documented progression or date of death from any cause	up to 2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival(OS)	From date of randomization until the date of death from any cause	up to 2 year
Objective Response Rate (ORR)	From date of randomization until the date of death from any cause	up to 1 year

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital
• Collaborators: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Zhiyong Ma, Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2017
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): December 18, 2017
• Last Update Submitted That Met QC Criteria: December 13, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenocarcinoma; Adenocarcinoma of Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Folic Acid Antagonists; Pemetrexed; Apatinib
• Other Study ID Numbers: AHEAD-HNP012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No