NL-OMON56744
Not yet recruiting
Not Applicable
A performance evaluation study for the testing of DNA extracted from either tumor tissue biopsy samples or plasma, using the therascreen® EGFR Plus RGQ PCR Kit, from subjects with Non-Small Cell Lung Cancer, being screened for inclusion in Taiho Oncology, Inc*s Clinical Trial (Protocol No. 10073010). - Testing samples using the therascreen EGFR Plus RGQ PCR Kit.
QIAGE0 sites15 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- QIAGE
- Enrollment
- 15
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Provide written informed consent
- •2\. \>\=18 years of age (or meets the country\*s regulatory definition for legal
- •whichever is greater)
- •3\. Histologically or cytologically confirmed, locally advanced, non\-resectable
- •or metastatic
- •4\. Has received the following prior treatment and no more than 2 lines of prior
- •chemotherapy for locally advanced or metastatic disease setting:
- •a. Part A1 (Phase 1 Dose Escalation): Standard of care (SOC) that is
- •available to the
- •patient, unless contraindicated or intolerable to the patient
Exclusion Criteria
- •1\.Currently receiving an investigational drug in a clinical trial or
- •participating in any other
- •type of medical research judged not to be scientifically or medically
- •compatible with this
- •2\. Has received prior treatment with any of the following within the specific
- •prior to the first dose of study treatment:
- •a. Major surgery/surgical therapy for any cause within 4 weeks; the patient
- •recovered adequately from the toxicity and/or complications of the
- •intervention prior
- •to starting study treatment
Outcomes
Primary Outcomes
Not specified
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