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Lapatinib Plus Trametinib in KRAS Mutant NSCLC

NCT02230553 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-07-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Lapatinib

DRUG

trametinib

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • F Opdam, MD, PhD · The Netherlands Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-07
Primary Completion
2019-07-29
Completion
2019-08-06

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02230553 on ClinicalTrials.gov