Lung Cancer, Non-Small CellPhase 1NCT00528281
A Phase II Trial of Lapatinib (TYKERB) + Pemetrexed (ALIMTA) in Advanced Non Small Cell Lung Cancer With an Initial Dose Finding Phase
A Phase 1 study testing Lapatinib and Pemetrexed in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 5 sites in 4 countries.
Trial summary
This phase II study is a single-arm, two-stage, multicentre study to determine the clinical activity of lapatinib in combination with pemetrexed in patients with Non-Small Cell Lung Cancer (NSCLC) who have received one prior cytotoxic chemotherapy regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non-Small Cell
- What is being tested?
- Lapatinib and Pemetrexed
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 20 Sep 2007to 27 May 2009
- Phase
- Phase 1
- 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
- Signed informed consent;
- Patients must be 18 years old;
- Subjects must have stage IIIB or IV NSCLC .
- Recurrent or persistent NSCLC following one previous line of cytotoxic chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;
- Life expectancy of 12 weeks;
- Have adequate organ function baseline laboratory values for inclusion;
Who cannot join
- History of other malignancy. Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible;
- Known history of or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis except for individuals who have previously treated CNS metastases, are asymptomatic, and have had no requirement for steroids or antiseizure medication for = 3 months prior to study enrollment.
- Peripheral neuropathy of grade 3 or higher;
- Concurrent cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, and tumor embolization).
- Prior exposure to pemetrexed or an EGFR inhibitor in combination with 5-FU or a 5FU prodrug.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Germany2 sites
GSK Investigational Site
Großhansdorf, Schleswig-Holstein, 22927
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, 69126
United Kingdom1 site
GSK Investigational Site
Newcastle upon Tyne, NE7 7DN
About this study
Official title: A Single-arm, Two-stage Phase II Study of Lapatinib and Pemetrexed in the Second Line Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer
This phase II study is a single-arm, two-stage, multicentre study to determine the clinical activity of lapatinib in combination with pemetrexed in patients with Non-Small Cell Lung Cancer (NSCLC) who have received one prior cytotoxic chemotherapy regimen. There will be a short safety run in portion of the study to determine the optimal treatment regimen (OTR) for the combination, since these two drugs have not previously been used together.
Approximately 27 patients will be enrolled into the first stage of the study and if sufficient responses are seen an additional 27 patients will be enrolled into the second stage giving an overall evaluable patient number of 54. Patients will be treated with pemetrexed plus lapatinib at the determined OTR to disease progression, death or withdrawal from the study treatment for any reason.
Safety and efficacy assessments will be performed on all patients at 6-week intervals, as well as at the end of treatment. Patients withdrawn from study treatment with stable disease will be assessed every 6 weeks until progression. Thereafter, patients will be followed for survival at approximately 12-week intervals until death or to a maximum of 5 years after last patient is enrolled, whichever comes first.
- Conditions
- Lung Cancer, Non-Small Cell
- Being tested
- Lapatinib, Pemetrexed
- Keywords
- Non Small Cell Lung Cancer (NSCLC), Pemetrexed,, Lapatinib (GW572016),
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LapatinibDrug
Lapatinib was administered once daily orally. Patients will begin treatment at Dose Level 0, using a lower dose of pemetrexed, 400mg (approved dose is 500mg). Absent a DLT or need for treatment delay in cycle 1, Dose level 0 or 1, patients may be dose escalated to dose level 1 or 2, respectively in cycle 2.
PemetrexedDrug
Pemetrexed is administered intravenously on a 21 day schedule. Two dose levels are used in the dose escalation: 400 and 500 mg.
| Study group | Role | What they receive |
|---|---|---|
| Lapatinib + pemetrexed | Experimental | This is a single-arm, two-stage, multicenter Phase II study to determine the clinical activity of pemetrexed with lapatinib. Receives: Drug: Lapatinib; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
OTR of the combination of lapatinib and pemetrexed
Secondary outcomes (2)
anti-tumour activity of lapatinib in terms of overall response rate
anti-tumour activity of lapatinib in terms of duration of response, time to response, time to progression, overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2007 (estimated)
- Study start20 Sep 2007
- Primary completion27 May 2009
- Study completion27 May 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer, Non-Small CellStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528281
- Sponsor's protocol ID
- EGF109462
- Status last verified
- Nov 2017
- First submitted
- 11 Sep 2007
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ramlau R, Thomas M, Novello S, Plummer R, Reck M, Kaneko T, Lau MR, Margetts J, Lunec J, Nutt J, Scagliotti GV. Phase I Study of Lapatinib and Pemetrexed in the Second-Line Treatment of Advanced or Metastatic Non-Small-Cell Lung Cancer With Assessment of Circulating Cell Free Thymidylate Synthase RNA as a Potential Biomarker. Clin Lung Cancer. 2015 Sep;16(5):348-57. doi: 10.1016/j.cllc.2015.01.004. Epub 2015 Jan 20.
PubMed 25700774
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Two-stage Phase II Study of Lapatinib and Pemetrexed in the Second Line Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00528281
- Acronym / sponsor ID
- EGF109462
- Conditions
- Lung Cancer, Non-Small Cell
- Keywords
- Non Small Cell Lung Cancer (NSCLC), Pemetrexed,, Lapatinib (GW572016),
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2007 (actual)
- Primary completion
- 27 May 2009 (actual)
- Study completion
- 27 May 2009 (actual)
- First posted
- 12 Sep 2007 (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 phase II study is a single-arm, two-stage, multicentre study to determine the clinical activity of lapatinib in combination with pemetrexed in patients with Non-Small Cell Lung Cancer (NSCLC) who have received one prior cytotoxic chemotherapy regimen. There will be a short safety run in portion of the study to determine the optimal treatment regimen (OTR) for the combination, since these two drugs have not previously been used together.
Approximately 27 patients will be enrolled into the first stage of the study and if sufficient responses are seen an additional 27 patients will be enrolled into the second stage giving an overall evaluable patient number of 54. Patients will be treated with pemetrexed plus lapatinib at the determined OTR to disease progression, death or withdrawal from the study treatment for any reason.
Safety and efficacy assessments will be performed on all patients at 6-week intervals, as well as at the end of treatment. Patients withdrawn from study treatment with stable disease will be assessed every 6 weeks until progression. Thereafter, patients will be followed for survival at approximately 12-week intervals until death or to a maximum of 5 years after last patient is enrolled, whichever comes first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lapatinib + pemetrexed | Experimental | Drug: Lapatinib, Drug: PemetrexedThis is a single-arm, two-stage, multicenter Phase II study to determine the clinical activity of pemetrexed with lapatinib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent;
- Patients must be 18 years old;
- Subjects must have stage IIIB or IV NSCLC .
- Recurrent or persistent NSCLC following one previous line of cytotoxic chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;
Key exclusion criteria (5 listed)
- History of other malignancy. Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible;
- Known history of or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis except for individuals who have previously treated CNS metastases, are asymptomatic, and have had no requirement for steroids or antiseizure medication for = 3 months prior to study enrollment.
- Peripheral neuropathy of grade 3 or higher;
- Concurrent cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, and tumor embolization).
- Prior exposure to pemetrexed or an EGFR inhibitor in combination with 5-FU or a 5FU prodrug.
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 |
|---|---|---|
| LapatinibLapatinib was administered once daily orally. Patients will begin treatment at Dose Level 0, using a lower dose of pemetrexed, 400mg (approved dose is 500mg). Absent a DLT or need for treatment delay in cycle 1, Dose level 0 or 1, patients may be dose escalated to dose level 1 or 2, respectively in cycle 2. | Drug | Lapatinib + pemetrexed |
| PemetrexedPemetrexed is administered intravenously on a 21 day schedule. Two dose levels are used in the dose escalation: 400 and 500 mg. | Drug | Lapatinib + pemetrexed |
Primary outcome
OTR of the combination of lapatinib and pemetrexed
2 secondary outcomes
anti-tumour activity of lapatinib in terms of overall response rate
anti-tumour activity of lapatinib in terms of duration of response, time to response, time to progression, overall survival
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 17 Nov 2017.
- Background: PubMed 25700774Ramlau R, Thomas M, Novello S, Plummer R, Reck M, Kaneko T, Lau MR, Margetts J, Lunec J, Nutt J, Scagliotti GV. Phase I Study of Lapatinib and Pemetrexed in the Second-Line Treatment of Advanced or Metastatic Non-Small-Cell Lung Cancer With Assessment of Circulating Cell Free Thymidylate Synthase RNA as a Potential Biomarker. Clin Lung Cancer. 2015 Sep;16(5):348-57. doi: 10.1016/j.cllc.2015.01.004. Epub 2015 Jan 20.
- Results for study EGF109462 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lapatinib and Pemetrexed in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 5 sites in 4 countries.
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 7 inclusion and 5 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 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Italy, Poland, United Kingdom. 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 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.
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?
OTR of the combination of lapatinib and pemetrexed. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00528281, which also lists 1 linked publication.
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 17 Nov 2017.