EUCTR2013-001494-24-DE
Active, not recruiting
Phase 1
A Randomized Prospective Trial of Adjuvant Chemotherapy in Patients with Completely Resected Stage I or IIA Non-Squamous Non-Small Cell Lung Cancer Identified as High or Intermediate Risk by a 14-Gene Prognostic Assay
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Completely resected stage I or IIA non-squamous non-small cell lung cancer (NSCLC)
- Sponsor
- Razor Genomics, Inc.
- Enrollment
- 1050
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Written informed consent (the informed consent document must have been approved by the appropriate Institutional Review Board/Independent Ethics Committee (IRB/IEC). Consent
- •must be obtained and signed and witnessed PRIOR to any study specific activity.
- •2\. Age \= 18 years
- •3\. Able to comply with the protocol, including acceptable candidacy for adjuvant chemotherapy consisting of cisplatin or carboplatin along with paclitaxel, vinorelbine or pemetrexed, according to investigator choice and administered in accordance with the protocol SmPCs and likely compliance with follow\-up for anticipated length of study (i.e. 5 years from the initiation of enrollment).
- •4\. Willing to be randomized to chemotherapy.
- •5\. Histologically documented completely resected (R0\) Stage I or IIA non\-squamous NSCLC per 8th edition, TNM staging system. Mixed histologies that include a squamous cell or small cell or neuroendocrine component are eligible for the study, as long as they contain at least some component that is neither squamous cell, nor small cell nor neuroendocrine. Eligible resections include segmentectomy, lobectomy, bi\-lobectomy, sleeve lobectomy, and pneumonectomy.
- •Resections via wedge resection will not be eligible. Complete resection must also be accompanied by mediastinal lymph
- •node sampling via mediastinoscopy, bronchoscopic sampling (e.g., endobronchial ultrasound guided biopsy) or surgical sampling. Nodes must be sampled from at least one of the following nodal stations: levels 2, 4, 7, 8, 9 for a right\-sided cancer and levels 2, 4, 5, 6, 7, 8, 9 for left\-sided cancers.
- •6\. Adequate tissue sample available for 14\-Gene Prognostic Assay (paraffin block with tumor occupying at least 25% of the tissue surface area)
- •7\. Life expectancy excluding NSCLC diagnosis \= 5 years
Exclusion Criteria
- •1\. Final pathologic diagnosis on resected specimen is pure squamous cell, pure small cell or pure neuroendocrine histology, or any combination of only these three histologies
- •2\. Evidence of greater than stage I or IIA pathologic staging per the 8th edition of the TNM staging system, including loco\-regional regional (hilar) or mediastinal lymph node involvement or nodal enlargement that has not been biopsied, or
- •of distant metastatic disease (lesions that have been biopsy\-proven or that are suspicious on brain MRI and/or PET scan)
- •3\. Evidence of incomplete resection, including positive resection margins, additional suspect nodules
- •4\. Pregnant or lactating women
- •5\. n/a for Germany
- •6\. Active infection, either systemic or at site of primary resection
- •7\. Any pre\-operative systemic chemotherapy or treatment with an anti\-cancer agent within 5 years prior to study enrollment
- •8\. Radiotherapy to the chest in the immediate pre\- or post\-operative period.
- •9\. Malignancies other than the current NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated locally with curative intent, ductal carcinoma in situ treated surgically with curative intent
Outcomes
Primary Outcomes
Not specified
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