APatinib Plus Chemotherapy vErsus Chemotherapy As First-line Treatment for Advanced NSCLC

NCT03164694 | Withdrawn Phase 2

• 1 other identifier: GASTO1006
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to studying the addition of apatinib with chemotherapy to investigate the efficacy and safety of apatinib in combination with chemotherapy in patients with advanced NSCLC.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival was assessed from randomization to death as a result of any cause.

  1 year after the last patient is randomized

Secondary Outcomes (2)

• Disease-free survival

  1 year after the last patient is randomized

• Number of Participants with Adverse Events

  1 year

Study Arms (2)

Apatinib

EXPERIMENTAL

Patients were given pemetrexed (500 mg/m2) plus carboplatin (AUC =5) plus apatinib. Apatinib was given 850 mg per day orally at day one of chemotherapy.

Drug: Apatinib; Drug: Pemetrexed; Drug: Carboplatin

Control

ACTIVE COMPARATOR

Patients were given pemetrexed (500 mg/m2) plus carboplatin (AUC =5).

Drug: Pemetrexed; Drug: Carboplatin

Interventions

Apatinib DRUG

Apatinib was given 850 mg per day orally.

Apatinib

Pemetrexed DRUG

pemetrexed (500 mg/m2)

Apatinib; Control

Carboplatin DRUG

carboplatin (AUC =5)

Apatinib; Control

Eligibility Criteria

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

You may qualify if:

• Target population is advanced NSCLC (IIIB-IV) without EGFR mutation, ALK gene rearrangement, and ROS1 gene rearrangement.
• Written informed consent provided.
• Male and female patients aged ≥18 years, \< 75 years.
• Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Life expectancy ≥12 weeks.
• Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
• Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
• Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min.
• Female subjects should not be pregnant or breast-feeding.

You may not qualify if:

• Known severe hypersensitivity to apatinib or any of the excipients of this product.
• Inability to comply with protocol or study procedures.
• A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
• A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
• Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy).
• Patients with prior radiotherapy
• History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
• Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
• Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this.
• Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.
• Patient who has active serious infection (e.g. pyrexia of or 38.0℃ over)

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

apatinib; Pemetrexed; Carboplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

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; Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 24, 2017
• Study Start: May 20, 2017
• Primary Completion: May 20, 2025
• Study Completion (Estimated): May 20, 2027
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

CN (1)