Phase I/II study with lapatinib plus trametinib in patients with metastaticKRAS mutant non-small cell lungcancer - Lapatinib plus trametinib in KRASm non-small cell lung cancer

The Netherlands Cancer Institute0 sites132 target enrollmentJune 17, 2014

Overview

No summary available.

Registry

who.int

Start Date

June 17, 2014

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Histological or cytological proof of metastatic NSCLC ; for PART B: treated with first line therapy for metastatic disease only.
•2\.Written documentation of a known pathogenic KRAS (exon 2, 3 or 4\) mutation and PIK3CA wild\-type (exon 9 and 20\).
•3\.Age \= 18 years.
•4\.Able and willing to give written informed consent.
•5\.WHO performance status of 0 or 1 (part A and B)
•6\.Able to swallow and retain orally administered medications and does not have clinically significant gastrointestinal abnormalities that may alter absorption (e.g. malabsorption syndrome or major resection of the stomach or bowel)
•7\.Able and willing to undergo blood sampling for PK and PD analysis.
•8\.Able and willing to undergo a tumor biopsy prior to start, after two weeks on therapy and upon progression of disease
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•1\.Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment.
•2\.History of another primary malignancy
•3\.Symptomatic or untreated leptomeningeal disease.
•4\.Symptomatic brain metastasis. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid and anticonvulsant therapy (for at least 6 weeks) are allowed to enrol. Radiotherapy for brain metastasis must have been completed at least 6 weeks prior to start of study treatment. Brain metastasis must be stable with verification by imaging (e.g. brain MRI or CT completed at screening demonstrating no current evidence of progressive brain metastases). Patients are not permitted to receive anti\-epileptic drugs or corticosteroids.
•5\.Patients previously treated with any targeted drug combination known to interfere with EGFR, HER\-2, HER\-3, HER\-4 or MAPK\- and PI3K\-pathway components, including inhibitors of PI3K, AKT, mTOR, BRAF, MEK and ERK.
•6\.History of interstitial lung disease or pneumonitis