RT Plus EGFR-TKI for Wild-type NSCLC

Thoracic Radiotherapy Combined With EGFR-TKI for Wild-type Non-small Cell Lung Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer; Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI)
• Intervention / Treatment: Drug: Erlotinib (trade name: Tarceva®) or Icotinib (trade name: Conmana®); Radiation: Radiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhishuang Zheng, Dr; Phone Number: +8657186826086; Email: zhengzs19841130@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Hangzhou Cancer Hospital
      • Contact: Zhishuang Zheng; Email: zhengzs19841130@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. NSCLC confirmed by histopathology or cytology;
2. Stage IIA - IV NSCLC ,unresectable and could not tolerate chemoradiotherapy;
3. 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];
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
5. Expectancy life >= 3 months;

Exclusion Criteria:

1. Had systemic anit-NSCLC treatments;
2. Had be treated by HER-targeting agents;
3. Had local radiotherapy for NSCLC;
4. Has upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer;
5. 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);
6. Any evidence to indicate moderate or severe chronic obstructive pulmonary disease (COPD);
7. Known hypersensitivity to EGFR-TKI agents or relevant components in the formulation;
8. Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection;
9. Pregnancy or breast-feeding women;
10. Ingredients mixed with small cell lung cancer patients;
11. 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.

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: Bioradiotherapy; 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®); Erlotinib (trade name: Tarceva®) (150mg oral daily) or Icotinib (trade name: Conmana®) (125mg oral three times a day).; Radiation: Radiotherapy; Concurrent radiotherapy total dose 60-66 Gy in 2 Gy fractions. One fraction per day, and 5 fractions per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response rate	week 3-4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0.	Toxicity of the treatment will be evaluated according to the common toxicity criteria for adverse events version 3.0 (CTCAE v3.0).	year 0- year 2
Progression-free survival	Progression-free survival (PFS) will be calculated from the date of treatment initiation to the date of documented failure (local recurrence or metastasis occurrence) or the date of the last follow-up for those remaining.	year 0- year 2
Overall survival	Overall survival (OS) wiil be determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.	year 0- year 2

Collaborators and Investigators

• Sponsor: Hangzhou Cancer Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: April 4, 2016
• First Submitted That Met QC Criteria: April 11, 2016
• First Posted (Estimate): April 14, 2016

Study Record Updates

• Last Update Posted (Estimate): April 14, 2016
• Last Update Submitted That Met QC Criteria: April 11, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Non-small cell lung cancer; Radiotherapy; wild type; epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Erlotinib Hydrochloride
• Other Study ID Numbers: HangzhouCH04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED