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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01038037
Recruitment Status : Terminated (
  1. Very low enrollment rate.
  2. Recent studies question the effect of adding panitumumab in this category of patients.
  3. Too high toxicity rate
First Posted : December 23, 2009
Last Update Posted : December 4, 2014
Information provided by (Responsible Party):
Vejle Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Carboplatin Drug: Vinorelbine Drug: panitumumab Phase 2

Detailed Description:
Advanced NSCLC holds a very poor prognosis with a moderate response rate to standard chemotherapy. The standard first-line treatment for advanced NSCLC is platinum based combination chemotherapy. The response rates are less than 30% and a substantial amount of patients will experience unnecessary toxicity in terms of e.g. nausea, vomiting, neuropathies or a considerable risk of renal toxicity. The median progression free survival is 3-4 months and consequently, the median overall survival is less than one year (Hotta et al 2007). Addition of new biological agents to standard chemotherapy regimens may improve the outcome for these patients.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of First-Line Chemotherapy and Panitumumab in Advanced NSCLC Selected by Mutational Status
Study Start Date : January 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Panitumumab
U.S. FDA Resources

Intervention Details:
    Drug: Carboplatin
    i.v. day 1: AUC 5 x (GFR + 25) mg q3w
    Drug: Vinorelbine
    i.v. day 1: 30 mg/m2 q3w Orally day 8: 60 mg/m2 q3w
    Drug: panitumumab
    i.v. day 1: 9 mg/kg q3w

Primary Outcome Measures :
  1. Response rate [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: Up to 3 years ]
  2. Overall survival [ Time Frame: Up to 3 years. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01038037

Vejle Hospital
Vejle, Denmark, DK-7100
Sponsors and Collaborators
Vejle Hospital

Responsible Party: Vejle Hospital Identifier: NCT01038037     History of Changes
Other Study ID Numbers: 2009-015068-32
First Posted: December 23, 2009    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014

Keywords provided by Vejle Hospital:
Lung Cancer
Non small cell lung cancer
Triple mutational status

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antibodies, Monoclonal
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Immunologic Factors
Physiological Effects of Drugs