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Trial record 93 of 125 for:    lapatinib | Recruiting, Active, not recruiting, Completed Studies | Phase 2

Lapatinib Plus Trametinib in KRAS Mutant NSCLC (M14LTK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02230553
Recruitment Status : Recruiting
First Posted : September 3, 2014
Last Update Posted : August 31, 2018
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Lapatinib Drug: trametinib Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study With Lapatinib Plus Trametinib in Patients With Metastatic KRAS Mutant Non-small Cell Lung Cancer
Study Start Date : October 2014
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: lapatinib + trametinib
lapatinib: oral tablets, once daily trametinib: oral tablets, once daily
Drug: Lapatinib
Drug: trametinib

Primary Outcome Measures :
  1. Incidence rate of dose-limiting toxicities [ Time Frame: 1.5 years ]
  2. progression free survival [ Time Frame: 2.5 years ]
  3. overall response rate [ Time Frame: 2.5 years ]

Secondary Outcome Measures :
  1. Incidence and severity of adveres events [ Time Frame: 2.5 years ]
  2. Plasma concentration [ Time Frame: 2.5 years ]
  3. Duration of response [ Time Frame: 2.5 years ]
  4. Time to response [ Time Frame: 2.5 years ]
  5. Overall survival [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02230553

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Contact: F Opdam, MD,PhD 0031205122446
Contact: S Huijberts, MD 0031205129111

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The Netherlands Cancer Institute Recruiting
Amsterdam, Netherlands, 1066CX
Contact: N HM Steeghs, MD, PhD    0031205122446   
Sponsors and Collaborators
The Netherlands Cancer Institute
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Study Director: F Opdam, MD, PhD The Netherlands Cancer Institute

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Responsible Party: The Netherlands Cancer Institute Identifier: NCT02230553     History of Changes
Other Study ID Numbers: NL49551.031.14
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action