RT Plus EGFR-TKI for Wild-type NSCLC

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02738983
• Other study ID #: HangzhouCH04
• Status: Recruiting
• Phase: Phase 2
• First received: April 4, 2016
• Last updated: April 11, 2016
• Start date: January 2012
• Est. completion date: December 2017

Study information

• Verified date: April 2016
• Source: Hangzhou Cancer Hospital
• Contact: Zhishuang Zheng, Dr
• Phone: +8657186826086
• Email: zhengzs19841130[@]163.com
• Is FDA regulated: No
• Health authority: China: Hangzhou Cancer Hospital
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI)
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
China	Hangzhou Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		week 3-4	No
Secondary	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	No
Secondary	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	No
Secondary	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	No