First-Line Chemotherapy and Panitumumab in Advanced Non-Small Cell Lung Cancer

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the addition of panitumumab to standard chemotherapy in first-line treatment of advanced Non Small Cell Lung Cancer improves the treatment outcome. Patients are selected based on triple mutational status.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vejle Hospital
• Treatments: Antibodies, Monoclonal; Carboplatin; Panitumumab; Vinorelbine

Criteria

Inclusion Criteria:

• Histologically confirmed metastatic (stage IV) NSCLC

• Measurable disease according to RECIST v.1.0 2009

• KRAS, BRAF and PI3K wild type in primary tumor or metastatic tissue.

• Age ≥18

• PS < 2

• Adequate organ function

Haematology:

• Neutrophil count ≥1.5x10^9/L

• Platelet count ≥100x10^9/L

• Leucocyte count > 3,000/mm

Hepatic function:

• Total bilirubin ≤ 1.5 times the upper normal limit (UNL)

• Serum transaminases ≤ 2.5xUNL in absence of liver metastases, or ≤ 5xUNL in presence of liver metastases

Renal Function:

• Creatinine clearance ≥ 50 mL/min and serum creatinine ≤ 1.5xUNL

Metabolic function:

• Magnesium ≥ lower limit of normal.

• Calcium ≥ lower limit of normal.

Consent to translational research studies

Written informed consent

Exclusion Criteria:

• Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment/randomization, active severe infections or other concurrent disease.

• Known CNS metastasis (pretreatment routine assessment not required)

• Prior chemotherapy for metastatic disease

• Indication for radiation therapy or prior radiotherapy within 30 days before treatment start.

• Other malignant diseases within 5 years prior to inclusion in the study, except basal cell squamous carcinoma of the skin and cervical carcinoma-in-situ.

• Other experimental therapy within 30 days prior to treatment initiation.

• History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.

• Patients pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.

• Patients (male or female) not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.