Clinical Trials /

Lapatinib Plus Trametinib in KRAS Mutant NSCLC

NCT02230553

Description:

This is an open-label phase I/II multi-center study consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of lapatinib combined with trametinib in patients with metastatic KRASm and PIK3CA wild-type (PIK3CAwt) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized comparison of the lapatinib-trametinib combination versus standard of care therapy in patients with metastatic KRASm/PIK3CAwt NSCLC.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Lapatinib Plus Trametinib in KRAS Mutant NSCLC
  • Official Title: Phase I/II Study With Lapatinib Plus Trametinib in Patients With Metastatic KRAS Mutant Non-small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: NL49551.031.14
  • NCT ID: NCT02230553

Conditions

  • Colorectal Cancer

Interventions

DrugSynonymsArms
Lapatiniblapatinib + trametinib
trametiniblapatinib + trametinib

Purpose

This is an open-label phase I/II multi-center study consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of lapatinib combined with trametinib in patients with metastatic KRASm and PIK3CA wild-type (PIK3CAwt) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized comparison of the lapatinib-trametinib combination versus standard of care therapy in patients with metastatic KRASm/PIK3CAwt NSCLC.

Trial Arms

NameTypeDescriptionInterventions
lapatinib + trametinibExperimentallapatinib: oral tablets, once daily trametinib: oral tablets, once daily
  • Lapatinib
  • trametinib

Eligibility Criteria

        Inclusion Criteria:

          -  Histological or cytological proof of metastatic NSCLC; for PART B: treated with first
             line therapy for metastatic disease only.

          -  Written documentation of a known pathogenic KRAS (exon 2, 3 or 4) mutation and PIK3CA
             wild-type (exon 9 and 20)

          -  Age ≥ 18 years

          -  Able and willing to give written informed consent

          -  WHO performance status of 0 or 1 (part A and B)

        Exclusion Criteria:

          -  Any treatment with investigational drugs within 30 days prior to receiving the first
             dose of investigational treatment.

          -  History of another primary malignancy

          -  Symptomatic or untreated leptomeningeal disease

          -  Symptomatic brain metastasis

          -  History of interstitial lung disease or pneumonitis

          -  Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2
             type patients

          -  Retinal degenerative disease (hereditary retinal degeneration or age-related macular
             degeneration), or a history of uveitis, retinal vein occlusion, central serous
             retinopathy, or retinal detachment

          -  Patients with left ventricular ejection fraction (LVEF) < 50%
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence rate of dose-limiting toxicities
Time Frame:1.5 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Incidence and severity of adveres events
Time Frame:2.5 years
Safety Issue:
Description:
Measure:Plasma concentration
Time Frame:2.5 years
Safety Issue:
Description:
Measure:Duration of response
Time Frame:2.5 years
Safety Issue:
Description:
Measure:Time to response
Time Frame:2.5 years
Safety Issue:
Description:
Measure:Overall survival
Time Frame:3 years
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:The Netherlands Cancer Institute

Last Updated

November 8, 2017