RT Plus EGFR-TKI for Wild-type NSCLC

Hangzhou Cancer Hospital

Status and phase: Unknown; Phase 2

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02738983

HangzhouCH04

Details and patient eligibility

About

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.

Enrollment: 22 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Bioradiotherapy

Experimental group

Description:

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).

Treatment:

Radiation: Radiotherapy

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