RT Plus EGFR-TKI for Wild-type NSCLC

NCT02738983 | Unknown Phase 2

• 1 other identifier: HangzhouCH04
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Concurrent chemoradiotheray is the standard care for patients with locally advanced non-small cell lung cancer (NSCLC), but often accompanying with high toxicity and poor tolerability. Radiosensitization of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) has been proved in preclinical studies, and the safety of TKI combined with thoracic radiotherapy has also been evaluated in several phase II trials. The aim of study is to investigate the efficacy and safety of thoracic radiotherapy combined with TKI in wild-type EGFR patients who refused or unsuitable for concurrent chemoradiotherapy.

Conditions

Non-small Cell Lung Cancer; Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI)

Keywords

Non-small cell lung cancer; epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI); Radiotherapy; wild type

Outcome Measures

Primary Outcomes (1)

• Response rate

  week 3-4

Secondary Outcomes (3)

• Number of participants with treatment-related adverse events as assessed by CTCAE v3.0.

  year 0- year 2

• Progression-free survival

  year 0- year 2

• Overall survival

  year 0- year 2

Study Arms (1)

Bioradiotherapy

EXPERIMENTAL

Erlotinib (trade name: Tarceva®) (150mg oral daily) or Icotinib (trade name: Conmana®) (125mg oral three times a day) with concurrent radiotherapy to a total radiation dose of 60-66 Gray (Gy).

Drug: Erlotinib (trade name: Tarceva®) or Icotinib (trade name: Conmana®); Radiation: Radiotherapy

Interventions

Erlotinib (trade name: Tarceva®) or Icotinib (trade name: Conmana®) DRUG

Erlotinib (trade name: Tarceva®) (150mg oral daily) or Icotinib (trade name: Conmana®) (125mg oral three times a day).

Bioradiotherapy

Radiotherapy RADIATION

Concurrent radiotherapy total dose 60-66 Gy in 2 Gy fractions. One fraction per day, and 5 fractions per week.

Bioradiotherapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• NSCLC confirmed by histopathology or cytology;
• Stage IIA - IV NSCLC ,unresectable and could not tolerate chemoradiotherapy;
• Has measurable lesion \[according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, must have at least one evaluable lesion with the longest dimension \>= 10mm; if the evaluable lesion is lymph node, the shortest dimension should be measured and \>=15mm\];
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
• Expectancy life \>= 3 months;

You may not qualify if:

• Had systemic anit-NSCLC treatments;
• Had be treated by HER-targeting agents;
• Had local radiotherapy for NSCLC;
• Has upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer;
• Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival, cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor);
• Any evidence to indicate moderate or severe chronic obstructive pulmonary disease (COPD);
• Known hypersensitivity to EGFR-TKI agents or relevant components in the formulation;
• Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection;
• Pregnancy or breast-feeding women;
• Ingredients mixed with small cell lung cancer patients;
• 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.

Sponsors & Collaborators

• Hangzhou Cancer Hospital: lead

Study Sites (1)

Hangzhou Cancer Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; icotinib; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Shixiu Wu, MD

  Hangzhou Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Zhishuang Zheng, Dr

CONTACT

+8657186826086; zhengzs19841130@163.com

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: MD

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 14, 2016
• Study Start: January 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: April 14, 2016

Record last verified: 2016-04

Locations

CN (1)