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A Phase II Trial of Lapatinib (TYKERB) + Pemetrexed (ALIMTA) in Advanced Non Small Cell Lung Cancer With an Initial Dose Finding Phase

Primary Purpose

Lung Cancer, Non-Small Cell

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Lapatinib

Pemetrexed

About this trial

This is an interventional treatment trial for Lung Cancer, Non-Small Cell focused on measuring Non Small Cell Lung Cancer (NSCLC), Pemetrexed,, Lapatinib (GW572016),

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

GSK Investigational Site
GSK Investigational Site
GSK Investigational Site
GSK Investigational Site
GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lapatinib + pemetrexed

Arm Description

This is a single-arm, two-stage, multicenter Phase II study to determine the clinical activity of pemetrexed with lapatinib.

Outcomes

Primary Outcome Measures

OTR of the combination of lapatinib and pemetrexed

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00528281

First Posted

September 11, 2007

Last Updated

November 13, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00528281

Brief Title

A Phase II Trial of Lapatinib (TYKERB) + Pemetrexed (ALIMTA) in Advanced Non Small Cell Lung Cancer With an Initial Dose Finding Phase

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

September 20, 2007 (Actual)

Primary Completion Date

May 27, 2009 (Actual)

Study Completion Date

May 27, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer, Non-Small Cell

Keywords

Non Small Cell Lung Cancer (NSCLC), Pemetrexed,, Lapatinib (GW572016),

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lapatinib + pemetrexed

Arm Type

Experimental

Arm Description

This is a single-arm, two-stage, multicenter Phase II study to determine the clinical activity of pemetrexed with lapatinib.

Intervention Type

Drug

Intervention Name(s)

Lapatinib

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Intervention Description

Pemetrexed is administered intravenously on a 21 day schedule. Two dose levels are used in the dose escalation: 400 and 500 mg.

Primary Outcome Measure Information:

Title

OTR of the combination of lapatinib and pemetrexed

Secondary Outcome Measure Information:

Title

anti-tumour activity of lapatinib in terms of overall response rate

Title

anti-tumour activity of lapatinib in terms of duration of response, time to response, time to progression, overall survival

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Heidelberg

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

69126

Country

Germany

Facility Name

GSK Investigational Site

City

Grosshansdorf

State/Province

Schleswig-Holstein

ZIP/Postal Code

22927

Country

Germany

Facility Name

GSK Investigational Site

City

Orbassano (TO)

State/Province

Piemonte

ZIP/Postal Code

10043

Country

Italy

Facility Name

GSK Investigational Site

City

Poznan

ZIP/Postal Code

60-569

Country

Poland

Facility Name

GSK Investigational Site

City

Newcastle upon Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

25700774

Citation

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.

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A Phase II Trial of Lapatinib (TYKERB) + Pemetrexed (ALIMTA) in Advanced Non Small Cell Lung Cancer With an Initial Dose Finding Phase

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