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

Primary Purpose

Non Small Cell Lung Cancer

Status

Terminated

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Carboplatin

Vinorelbine

panitumumab

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Lung Cancer, Non small cell lung cancer, Triple mutational status, KRAS, BRAF, PI3K

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Vejle Hospital

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Progression free survival

Overall survival

Full Information

NCT ID

NCT01038037

First Posted

December 22, 2009

Last Updated

December 3, 2014

Sponsor

Vejle Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01038037

Brief Title

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

Acronym

Lung-TRIO

Official Title

A Phase II Study of First-Line Chemotherapy and Panitumumab in Advanced NSCLC Selected by Mutational Status

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Terminated

Why Stopped

Very low enrollment rate. Recent studies question the effect of adding panitumumab in this category of patients. Too high toxicity rate

Study Start Date

January 2010 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vejle Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer

Keywords

Lung Cancer, Non small cell lung cancer, Triple mutational status, KRAS, BRAF, PI3K

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

i.v. day 1: AUC 5 x (GFR + 25) mg q3w

Intervention Type

Drug

Intervention Name(s)

Vinorelbine

Intervention Description

i.v. day 1: 30 mg/m2 q3w Orally day 8: 60 mg/m2 q3w

Intervention Type

Drug

Intervention Name(s)

panitumumab

Intervention Description

i.v. day 1: 9 mg/kg q3w

Primary Outcome Measure Information:

Title

Response rate

Time Frame

Up to 3 years

Secondary Outcome Measure Information:

Title

Progression free survival

Time Frame

Up to 3 years

Title

Overall survival

Time Frame

Up to 3 years.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Vejle Hospital

City

Vejle

ZIP/Postal Code

DK-7100

Country

Denmark

12. IPD Sharing Statement

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

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