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

Phase 1

Completed

• Conditions: Lung Cancer, Non-Small Cell
• Interventions: Drug: Lapatinib; Drug: Pemetrexed

• Registration Number: NCT00528281
• Lead Sponsor: GlaxoSmithKline

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 Patients withdrawn from study treatment with stable disease will be assessed every 6 weeks until progression.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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-09-11
• Study First Submitted QC: 2007-09-11
• Study First Posted: 2007-09-12
• Study Start: 2007-09-20
• Primary Completion: 2009-05-27
• Study Completion: 2009-05-27
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-13
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lapatinib + pemetrexed	Lapatinib	This is a single-arm, two-stage, multicenter Phase II study to determine the clinical activity of pemetrexed with lapatinib.
Lapatinib + pemetrexed	Pemetrexed	This is a single-arm, two-stage, multicenter Phase II study to determine the clinical activity of pemetrexed with lapatinib.

Primary Outcome Measures

Name	Time	Method
OTR of the combination of lapatinib and pemetrexed

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Newcastle upon Tyne, United Kingdom