Clinical trial with or without chemotherapy after surgical resection of the primary lung cancer in patients with high risk of relapse based on the Pervenio? Lung RS Assay

• Conditions: Completely resected stage I non-squamous non-small cell lung cancer (NSCLC); MedDRA version: 14.1Level: LLTClassification code 10025044Term: Lung cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-001494-24-ES
• Lead Sponsor: Encore Clinical, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-16
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: ot Recruiting
• 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 follow-up especially for anticipated length of study (i.e. 5 years from the initiation of enrollment).
4. Histologically documented completely resected (R0) Stage I non-squamous NSCLC. Eligible resections include lobectomy, bi-lobectomy, sleeve lobectomy and pneumonectomy.
Resections via segmentectomy or wedge resection will not be eligible. Complete resection must also be accompanied, at a minimum, by intra-operative systematic mediastinal lymph
node sampling. Systematic sampling is defined as removal of at least one representative lymph node each from levels 4 and 7 for a right-sided cancer and from levels 5 and/or 6 and 7 for left-sided cancers. Complete mediastinal lymph node dissection (MLND), however, is preferred, and is defined as resection of all lymph nodes at those same levels for right- and
left-sided cancers.
5. Adequate tissue sample available for Pervenio testing (paraffin block with tumor occupying at least 25% of the tissue surface area)
6. Life expectancy excluding NSCLC diagnosis ? 5 years
7. ECOG performance status 0-1
8. Adequate haematological function*:
a. Absolute neutrophil count (ANC) ? 1500 cells/mm3 AND
b. Platelet count ? 100000 cells/mm3 AND
c. Haemoglobin ? 9 g/dL (may be transfused to maintain or exceed this level)
9. Adequate liver function*:
a. Total bilirubin < 1.5 x upper limit of normal (ULN) AND
b. Aspartate amiotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN
10. Adequate renal function*, with Serum creatinine ? 1.5 x ULN
11. Completely healed incisions
*Note: all laboratory values must be obtained within 14 days prior to randomization
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 700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 350

Exclusion Criteria

1. Final pathologic diagnosis on resected specimen is squamous cell histology
2. Evidence of greater than stage I pathologic staging, 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. Women with an intact uterus (unless amenorrhoeic for the previous 24 months) unwilling to use an effective means of contraception (including oral contraceptive, intrauterine
contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) during the study and for a period of 6 months following the last
administration of study chemotherapy. Men who do not agree to use effective contraception during the study and for a period of 90 days following the last administration of study chemotherapy.
6. Active infection, either systemic or at site of primary resection
7. Any pre-operative systemic chemotherapy or treatment with an anti-cancer agent
8. Any pre-or post operative radiotherapy to primary site or elsewhere
9. Malignancies other than 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 surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent
10. Treatment with any investigational drug or participation in another clinical trail 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