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: 21.1Level: PTClassification code 10029517Term: Non-small cell lung cancer stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10029518Term: Non-small cell lung cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-001494-24-FR
• Lead Sponsor: IFCT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-18
• Last Update Posted: 2 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1050

Inclusion Criteria

1. Written informed consent
2. Age = 18 years
3. Able to comply with the protocol, including acceptable candidacy for adjuvant chemotherapy and likely compliance with follow-up for anticipated length of study (i.e. 5 years from the initiation of enrollment).
4. Histologically documented completely resected (R0) Stage I or IIA non-squamous NSCLC (per 8th edition, TNM staging system)
5. Adequate tissue sample for the 14-Gene Prognostic Assay
6. Life expectancy excluding NSCLC diagnosis = 5 years
7. ECOG performance status 0-1
8. Adequate haematological function:
• Absolute neutrophil count (ANC) = 1500 cells/mm3 AND
• Platelet count = 100000 cells/mm3 AND
• Haemoglobin = 9 g/dL (may be transfused to maintain or exceed this level)
9. Adequate liver function:
• Total bilirubin < 1.5 x upper limit of normal (ULN) AND
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN
10. Adequate renal function, with Serum creatinine = 1.5 x ULN
11. Completely healed incisions
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1. Final pathologic diagnosis of pure squamous cell, pure small cell, or pure neuroendocrine histology, or any combination of only these three histologies
2. Evidence of greater than stage IIA pathologic staging
3. Evidence of incomplete resection
4. Pregnant or lactating women
5. Unwilling to use an effective means of contraception
6. Active infection, either systemic or at site of primary resection
7. Systemic chemotherapy or anti-cancer agent within 5 years prior to enrollment
8. Any pre- or post-operative radiotherapy
9. Malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated CIS of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically, ductal carcinoma in situ treated surgically
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 that
13. 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