Non Small Cell Lung CancerPhase 2Lung-TRIONCT01038037
First-Line Chemotherapy and Panitumumab in Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing Carboplatin, Vinorelbine and panitumumab in people with Non Small Cell Lung Cancer, run by Vejle Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Carboplatin, Vinorelbine and panitumumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 23 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2010to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Carboplatin, Vinorelbine, panitumumab
- Keywords
- Lung Cancer, Non small cell lung cancer, Triple mutational status, KRAS, BRAF, PI3K
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
i.v. day 1: AUC 5 x (GFR + 25) mg q3w
VinorelbineDrug
i.v. day 1: 30 mg/m2 q3w Orally day 8: 60 mg/m2 q3w
panitumumabDrug
i.v. day 1: 9 mg/kg q3w
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: Up to 3 years
Secondary outcomes (2)
Progression free survival
Measured: Up to 3 years
Overall survival
Measured: Up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJun 2013
- Study completionDec 2013
Why it stopped: 1. Very low enrollment rate. 2. Recent studies question the effect of adding panitumumab in this category of patients. 3. Too high toxicity rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038037
- Sponsor's protocol ID
- 2009-015068-32
- Other IDs
- 2009
- Acronym
- Lung-TRIO
- Status last verified
- Dec 2014
- First submitted
- 22 Dec 2009
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of First-Line Chemotherapy and Panitumumab in Advanced NSCLC Selected by Mutational Status
- ClinicalTrials.gov ID
- NCT01038037
- Acronym / sponsor ID
- Lung-TRIO / 2009-015068-32
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Lung Cancer, Non small cell lung cancer, Triple mutational status, KRAS, BRAF, PI3K
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 1. Very low enrollment rate. 2. Recent studies question the effect of adding panitumumab in this category of patients. 3. Too high toxicity rate
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 23 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carboplatini.v. day 1: AUC 5 x (GFR + 25) mg q3w | Drug | – |
| Vinorelbinei.v. day 1: 30 mg/m2 q3w Orally day 8: 60 mg/m2 q3w | Drug | – |
| panitumumabi.v. day 1: 9 mg/kg q3w | Drug | – |
Primary outcome
Response rate
Time frame: Up to 3 years
2 secondary outcomes
Progression free survival
Time frame: Up to 3 years
Overall survival
Time frame: Up to 3 years.
Results and safety
The study was stopped early (reason given: 1. Very low enrollment rate. 2. Recent studies question the effect of adding panitumumab in this category of patients. 3. Too high toxicity rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin, Vinorelbine and panitumumab in people with Non Small Cell Lung Cancer, run by Vejle Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 1. Very low enrollment rate. 2. Recent studies question the effect of adding panitumumab in this category of patients. 3. Too high toxicity rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014.