- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01038037
First-Line Chemotherapy and Panitumumab in Advanced Non-Small Cell Lung Cancer (Lung-TRIO)
December 3, 2014 updated by: Vejle Hospital
A Phase II Study of First-Line Chemotherapy and Panitumumab in Advanced NSCLC Selected by Mutational Status
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Enrollment (Actual)
23
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Vejle, Denmark, DK-7100
- Vejle Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate
Time Frame: Up to 3 years
|
Up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression free survival
Time Frame: Up to 3 years
|
Up to 3 years
|
Overall survival
Time Frame: Up to 3 years.
|
Up to 3 years.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (ACTUAL)
June 1, 2013
Study Completion (ACTUAL)
December 1, 2013
Study Registration Dates
First Submitted
December 22, 2009
First Submitted That Met QC Criteria
December 22, 2009
First Posted (ESTIMATE)
December 23, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
December 4, 2014
Last Update Submitted That Met QC Criteria
December 3, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Carboplatin
- Vinorelbine
- Panitumumab
Other Study ID Numbers
- 2009-015068-32
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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