NCT01038037

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

3.4 years

First QC Date

December 22, 2009

Last Update Submit

December 3, 2014

Conditions

Non Small Cell Lung Cancer

Keywords

Lung CancerNon small cell lung cancerTriple mutational statusKRASBRAFPI3K

Outcome Measures

Primary Outcomes (1)

  • Response rate

    Up to 3 years

Secondary Outcomes (2)

  • Progression free survival

    Up to 3 years

  • Overall survival

    Up to 3 years.

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +5 more criteria

You may not qualify if:

  • 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vejle Hospital

Vejle, DK-7100, Denmark

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Interventions

CarboplatinVinorelbinePanitumumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 23, 2009

Study Start

January 1, 2010

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations

DK(1)