Advanced non-small cell lung cancer with EGFR mutation
Conditions
Interventions
None listed
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Provision of informed consent prior to study-related procedures and testing. 2.Histological or cytological confirmation diagnosis of NSCLC. 3.Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy. 4.Radiological documentation of disease progression. 5.Patients with at least one or more EGFR-TKI treatment regimens in prior treatment. 6.Confirmation that the tumor harbors an EGFR mutation known to be associated any of EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, and L861Q). 7.WHO performance status 0-1 with no deterioration over the 2 weeks prior to consent and minimum life expectancy of 12 weeks. 8.At least one unirradiated lesion that can be accurately measured at baseline as >= 10mm in the longest diameter (except for lymph nodes, which must have short axis of >= 15mm) with computerized tomography (CT) or magnetic resonance imaging (MRI).
Exclusion criteria
Exclusion criteria: 1.Treatment history *Third-generation EGFR-TKI *Major surgery within 4 weeks of collection of plasma sample *Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of collection of plasma sample. 2.Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 2 with the exception of alopecia and grade 2 prior platinum-therapy related neuropathy. 3.Spinal cord compression or brain metastases 4.Any evidence, as judged by the investigator, etc., of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required. 5.Refractory nausea and vomiting, chronic gastrointestinal diseases or inability to swallow the formulated product or previous bowel resection, etc. 6.Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD 7.Inadequate bone marrow reserve or organ function within 28 days after registration 8.Women who are breast-feeding 9.Synchronous or metachronous (within 2 years) malignancies. 10.Judgment by the investigator that the patient should not participate in the study because the patient is unlikely to comply with study procedures, restrictions and requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to determine the power of detection and 95% confidence interval for ddPCR, cobas EGFR mutation test v2, and NGS, with respect to EGFR and T790M mutations that affect sensitivity to first- or second-generation EGFR-TKI treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Levels of concordance, sensitivity, and specificity will be studied in an exploratory manner for ddPCR, cobas EGFR mutation test v2, and NGS, using ddPCR as the reference, with respect to EGFR and T790M mutations that affect sensitivity to first- or second-generation EGFR-TKI treatment. Relationship between clinical demographics of patients in each of the somatic mutation positive groups (age, sex, PS at registration, histology, clinical stage, smoking status, etc.) and T790M mutation will be assessed using a logistic regression model. Mechanisms involved in acquired resistance to EGFR-TKIs other than T790M mutation will be studied using NGS. | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed