Clinical trial NCT02738983: RT Plus EGFR-TKI for Wild-type NSCLC
Official title: Thoracic Radiotherapy Combined With EGFR-TKI for Wild-type Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
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
Lead sponsor: Hangzhou Cancer Hospital
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 22
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Response rate
timeFrame: week 3-4
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v3.0.
timeFrame: year 0- year 2
measure: Progression-free survival
timeFrame: year 0- year 2
measure: Overall survival
timeFrame: year 0- year 2
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Hangzhou Cancer Hospital
name: Shixiu Wu, MD
role: STUDY_CHAIR
References: