The Efficacy and Drug Resistance Molecular Biology of Apatinib Combined With EGFR-TK1 Treated for Advanced Slow-progressed Non-Small Cell Lung Cancer (NSCLC)

NCT03811054 | Unknown Phase 2

• 1 other identifier: BeijingCH002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with advanced non-small cell lung cancer (NSCLC) who progress slowly after Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors（EGFR-TKI）resistance. The purpose of this study is to investigate the efficacy and drug resistance mechanism of Apatinib combine with EGFR-TK1 treated for advanced slow progressed non-small cell lung cancer and provide new treatment options.

Conditions

Non Small Cell Lung Cancer

Keywords

Apatinib; Non Small Cell Lung Cancer; EGFR TKI; slowly progress

Outcome Measures

Primary Outcomes (1)

• Objective response rates (ORR)

  Objective response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response according to Response Evaluation Criteria in Solid Tumors 1.1（RECIST1.1）

  two years

Secondary Outcomes (4)

• Disease control rate (DCR)

  two years

• Overall survival (OS)

  two years

• Progression free survival (PFS)

  two years

• Drug safety: Number of participants with treatment-related adverse events

  two years

Study Arms (1)

Apatinib combined with EGFR-TKI

EXPERIMENTAL

Apatinib 250 millgram（mg/day（d））combined with EGFR-TKI

Drug: Apatinib（250mg/d） combined with EGFR-TKI

Interventions

Apatinib（250mg/d） combined with EGFR-TKI DRUG

Patients with advanced non-small cell lung cancer (NSCLC) who had treated with EGFR-TKI and progressed slowly because of resistance are underwent with apatinib mesylate and continuous EGFR-TKI.

Apatinib combined with EGFR-TKI

Eligibility Criteria

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

You may qualify if:

• Informed consent should be obtained before treatment. Patients with good compliance.
• Histologically or cytologically confirmed IIIB/IV NSCLC.
• Progress in the treatment of EGFR TKI.
• Aged from 18 to 75 years (18 and 75 years are included); Gender Not Required.
• ECOG PS 0-1.
• Life expectancy ≥ 3 months.
• At least one measurable lesion (meet the requirements of the standard Response Evaluation Criteria In Solid Tumors (RESCIST) version 1.1). If the lesions that have received local treatment (radiation, radiofrequency, intervention, etc.) are the only lesions, it is required to have clear imaging progress.

You may not qualify if:

• Uncontrolled hypertension (systolic ≥140mmHg and/or diastolic ≥90mmHg after medication treatment); Poor control of blood sugar.
• Acute phase of cerebral infarction, or recovery period \<2 months.
• A variety of factors that affect the absorption of oral medications (such as inability to swallow, nausea and vomiting, chronic diarrhea, intestinal obstruction, etc.)
• Coagulation abnormality (INR\>1.5×ULN, APTT\>1.5×ULN), with bleeding tendency.
• Urine protein ≥ ++ or confirmed 24-hour urine protein quantitation \> 1.0 g.
• Pregnant or lactating women.
• Severe liver and kidney dysfunction (grade 4) .
• Allergic to any ingredient of apatinib mesylate.
• A history of abuse of psychotropic substances and are unable to quit smoking or mental disorders.
• According to the investigator's judgment, people with concomitant diseases that seriously endanger the safety of the patient or affect the patient's completion of the study.
• Surgery, major trauma or fracture, within 4 weeks before the treatment or unhealed wound before treatment.
• Severe heart disease, such as grade III or above (NYHA standard) congestive heart failure, grade III or above (CCS standard) angina, a history of myocardial infarction within 6 months before the treatment, or medication treated arrhythmia.
• Brain metastasis and meningeal metastasis.

Sponsors & Collaborators

• Beijing Chest Hospital: lead

Study Sites (1)

The Beijing Chest Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Liyan Xu, MD

CONTACT

86-89509157; xuliyan2009@yahoo.cn

Jing Liu

CONTACT

86-89509157

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Medical Oncology Department

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 22, 2019
• Study Start: December 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 22, 2019

Record last verified: 2019-01

Locations

CN (1)