Colorectal CancerPhase 1/2M14LTKNCT02230553
Lapatinib Plus Trametinib in KRAS Mutant NSCLC
A Phase 1/2 study testing Lapatinib and trametinib in people with Colorectal Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Lapatinib and trametinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Oct 2014to 6 Aug 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Study With Lapatinib Plus Trametinib in Patients With Metastatic KRAS Mutant Non-small Cell Lung Cancer
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
- Colorectal Cancer
- Being tested
- Lapatinib, trametinib
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LapatinibDrug
trametinibDrug
| Study group | Role | What they receive |
|---|---|---|
| lapatinib + trametinib | Experimental | lapatinib: oral tablets, once daily trametinib: oral tablets, once daily Receives: Drug: Lapatinib; Drug: trametinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of dose-limiting toxicities
Measured: 1.5 years
progression free survival
Measured: 2.5 years
overall response rate
Measured: 2.5 years
Secondary outcomes (5)
Incidence and severity of adveres events
Measured: 2.5 years
Plasma concentration
Measured: 2.5 years
Duration of response
Measured: 2.5 years
Time to response
Measured: 2.5 years
Overall survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study start7 Oct 2014
- Primary completion29 Jul 2019
- Study completion6 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- F Opdam, MD, PhD, Study director, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230553
- Sponsor's protocol ID
- NL49551.031.14
- Acronym
- M14LTK
- Status last verified
- Jul 2025
- First submitted
- 29 Aug 2014
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study With Lapatinib Plus Trametinib in Patients With Metastatic KRAS Mutant Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02230553
- Acronym / sponsor ID
- M14LTK / NL49551.031.14
- Conditions
- Colorectal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 7 Oct 2014 (actual)
- Primary completion
- 29 Jul 2019 (actual)
- Study completion
- 6 Aug 2019 (actual)
- First posted
- 3 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lapatinib + trametinib | Experimental | Drug: Lapatinib, Drug: trametiniblapatinib: oral tablets, once daily trametinib: oral tablets, once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lapatinib | Drug | lapatinib + trametinib |
| trametinib | Drug | lapatinib + trametinib |
Primary outcome
Incidence rate of dose-limiting toxicities
Time frame: 1.5 years
progression free survival
Time frame: 2.5 years
overall response rate
Time frame: 2.5 years
5 secondary outcomes
Incidence and severity of adveres events
Time frame: 2.5 years
Plasma concentration
Time frame: 2.5 years
Duration of response
Time frame: 2.5 years
Time to response
Time frame: 2.5 years
Overall survival
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
F Opdam, MD, PhD study director
The Netherlands Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lapatinib and trametinib in people with Colorectal Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of dose-limiting toxicities (time frame: 1.5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.