Clinical trial with or without chemotherapy after surgical resection of the primary lung cancer in patients with high or intermediate risk of relapse based on a 14-Gene Prognostic Assay

Phase 1

• Conditions: Completely resected stage I or IIA non-squamous non-small cell lung cancer (NSCLC); MedDRA version: 20.0Level: LLTClassification code 10025044Term: Lung cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-001494-24-DE
• Lead Sponsor: Razor Genomics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-23
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1050

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
8. ECOG performance status 0-1
- Completely healed incisions
For Germany:
9. Women without childbearing potential or
women of childbearing potential who have a negative hCG pregnancy test (either serum or urine) and who agree to meet one of the following criteria from the first administration of chemotherapy, during the treatment and for a period of 6 months following the last administration of chemotherapy:
• Correct use of two reliable contraception methods. This includes every combination of a hormonal implant, transdermal hormonal patch, hormonal vaginal device, hormonal injection or of an intrauterine device or system (IUD/IUS) with a barrier method (condom or occlusive cap),
• True abstinence (periodic abstinence and withdrawal are not acceptable methods of contraception),
• Sexual relationship only with female partners and/or sterile male partners.
10. Men who agree to meet one of the following criteria from the first administration of chemotherapy, during the treatment and for a period of 6 months following the last administration of chemotherapy:
• Correct use of two reliable contraception methods with female partners. This includes every combination of a hormonal implant, transdermal hormonal patch, hormonal vaginal device, hormonal injection or of an intrauterine device or system (IUD/IUS) with a barrier method (condom or occlusive cap),
• True abstinence (periodic abstinence and withdrawal are not acceptable methods of contraception),
• Sexual relationship only with male partners and/or sterile female partners.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 56
F.1

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
10. Treatment with any investigational drug or participation in another clinical trial within 28 days prior to enrollment.
11. Known hypersensitivity to any of the study treatment agents.
12. Evidence of any other disease including infection (see above) such as neurologic or metabolic dysfunction or physical examination finding giving reasonable suspicion of a disease or condition that contraindicates the use of systemic cytotoxic chemotherapy or puts the patient at high risk for treatment related complications.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified