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A Randomized Prospective Trial of Adjuvant Chemotherapy in Patients With Completely Resected Stage I Non-Squamous Non-Small Cell Lung Cancer Identified as High Risk by the Pervenio™ Lung RS Assay


N/A
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

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Trial Information

A Randomized Prospective Trial of Adjuvant Chemotherapy in Patients With Completely Resected Stage I Non-Squamous Non-Small Cell Lung Cancer Identified as High Risk by the Pervenio™ Lung RS Assay


Inclusion Criteria:



- Written informed consent

- Age ≥ 18 years

- Adequate tissue sample for Pervenio™ testing

- Histologically documented completely resected (R0) Stage I non-squamous NSCLC

- Life expectancy excluding NSCLC diagnosis ≥ 5 years

- ECOG performance status 0-1

- Adequate haematological function:

1. Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 AND

2. Platelet count ≥ 100000 cells/mm3 AND

3. Haemoglobin ≥ 9 g/dL (may be transfused to maintain or exceed this level)

- Adequate liver function:

1. Total bilirubin < 1.5 x upper limit of normal (ULN) AND

2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN

- Adequate renal function, with Serum creatinine ≤ 1.5 x ULN

- Completely healed incisions

Exclusion Criteria:

- Final pathologic diagnosis of squamous cell histology

- Evidence of greater than stage I pathologic staging

- Evidence of incomplete resection

- Pregnant or lactating women

- Unwilling to use an effective means of contraception

- Active infection, either systemic or at site of primary resection

- Prior systemic chemotherapy or anti-cancer agent

- Any pre- or post-operative radiotherapy

- 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

- Treatment with any investigational drug or participation in another clinical trial
within 28 days prior to enrollment

- Known hypersensitivity to any of the study treatment agents

- Evidence of any other disease including infection that contraindicates the use of
systemic cytotoxic chemotherapy or puts the patient at high risk for treatment
related complications

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Thierry Jahan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Institutional Review Board

Study ID:

EC-120888

NCT ID:

NCT01817192

Start Date:

May 2013

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-Squamous
  • Adjuvant Chemotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Highlands Oncology GroupSpringdale, Arkansas  72764