Last updated: 11/04/2018 06:31:10
A Phase II Trial of Lapatinib (TYKERB) + Pemetrexed (ALIMTA) in Advanced Non Small Cell Lung Cancer with an initial dose finding phase
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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 Patients withdrawn from study treatment with stable disease will be assessed every 6 weeks until progression.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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
OTR of the combination of lapatinib and pemetrexed
Timeframe: N/A
Secondary outcomes:
anti-tumour activity of lapatinib in terms of overall response rate
Timeframe: N/A
anti-tumour activity of lapatinib in terms of duration of response, time to response, time to progression, overall survival
Timeframe: N/A
Interventions:
Enrollment:
18
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Ramlau, R., Thomas, M., Plummer, R., Reck, M., Heussel, C. P., Lau, M., Parikh, R., Kaneko, T., Oliva, C., Novello, S. Phase I study of lapatinib, a dual-tyrosine kinase inhibitor, and pemetrexed in the second-line treatment of advanced or metastatic non-small-cell lung cancer, J Clin Oncol 27, 2009 (suppl; abstr e19027)
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;
Medical condition
Lung Cancer, Non-Small Cell
Product
lapatinib
Collaborators
Not applicable
Study date(s)
September 2007 to May 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- INCLUSION CRITERIA:
- Signed informed consent;
Inclusion and exclusion criteria
Inclusion criteria:
- INCLUSION CRITERIA:
- 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; EXCLUSION CRITERIA:
- 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 location(s)
Location
GSK Investigational Site
Orbassano (TO), Piemonte, Italy, 10043
Status
Study Complete
Location
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69126
Status
Study Complete
Location
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
Status
Study Complete
Location
GSK Investigational Site
Newcastle upon Tyne, United Kingdom, NE7 7DN
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2009-27-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study EGF109462 can be found on the GSK Clinical Study Register.
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