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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT01038037
First received: December 22, 2009
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Non Small Cell Lung Cancer
Drug: Carboplatin
Drug: Vinorelbine
Drug: panitumumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of First-Line Chemotherapy and Panitumumab in Advanced NSCLC Selected by Mutational Status

Resource links provided by NLM:


Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • Response rate [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 3 years. ] [ Designated as safety issue: No ]

Estimated Enrollment: 39
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01038037

Locations
Denmark
Vejle Hospital
Vejle, Denmark, DK-7100
Sponsors and Collaborators
Vejle Hospital
  More Information

No publications provided

Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT01038037     History of Changes
Other Study ID Numbers: 2009-015068-32
Study First Received: December 22, 2009
Last Updated: June 13, 2013
Health Authority: Denmark: Danish Medicines Agency
Denmark: National Board of Health

Keywords provided by Vejle Hospital:
Lung Cancer
Non small cell lung cancer
Triple mutational status
KRAS
BRAF
PI3K

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on October 19, 2014