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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 December 2012
• Main ID: NCT01038037
• Date of registration: 22/12/2009
• Primary sponsor: Vejle Hospital
• Public title: First-Line Chemotherapy and Panitumumab in Advanced Non-Small Cell Lung Cancer Lung-TRIO
• Scientific title: A Phase II Study of First-Line Chemotherapy and Panitumumab in Advanced NSCLC Selected by Mutational Status
• Date of first enrolment: January 2010
• Target sample size: 39
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01038037
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Denmark

Contacts

• Name: Anders Jakobsen, DMSc

• Name: Anders Jakobsen, DMsc

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Non Small Cell Lung Cancer

Intervention(s)

Drug: Carboplatin

Drug: panitumumab

Drug: Vinorelbine

Primary Outcome(s)

Response rate [Time Frame: Up to 3 years]

Secondary Outcome(s)

Overall survival [Time Frame: Up to 3 years.]

Progression free survival [Time Frame: Up to 3 years]

Secondary ID(s)

2009-015068-32

Source(s) of Monetary Support

Please refer to primary and secondary sponsors