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

• Conditions: Patients with advanced or metatstatic Non-Small Cell Lung Cancer who have received one prior platinum containing chemotherapy regimen; MedDRA version: 9.1Level: LLTClassification code 10061873Term: Non-small cell lung cancer

• Registration Number: EUCTR2007-002472-34-GB
• Lead Sponsor: GlaxoSmithKline Research and Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1. Signed informed consent;
2. Subjects must have histologically or cytology confirmed advanced (incurable stage
IIIB or IV according to the International Staging System) non small cell lung cancer (NSCLC) at primary diagnosis or relapsed after curative-intent surgery.
3. Recurrent or persistent NSCLC following one previous line of cytotoxic
chemotherapy. The previous regimen may also have included a biologic agent.
Subjects treated with an EGFR inhibitor in combination with a chemotherapy which
did not include a fluoropyrimidine may enter.
4. Prior surgery and radiotherapy are permitted, however, patients should have
recovered from acute side effects of radiation before the screening radiological
assessment. Concurrent radiotherapy during the study is prohibited;
5. Where available, archived or most recent tumour tissue for evaluation of genetic and intra-tumoral protein or mRNA expression levels of relevant biomarkers.
6. Measurable lesion(s) according to RECIST; At least 1 measurable lesion located outside of the prior radiation field or, if located within the prior field of irradiation, is increasing in size;
7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;
8. Life expectancy of 12 weeks;
9. Patients must be =18 years old;
10. A female is eligible to enter and participate in this study if she is of:
• Non-childbearing potential (i.e., women with functioning ovaries who have a current documented tubal ligation, women who had a hysterectomy, women who are
post-menopausal, or women who have had both ovaries surgically removed); or
• Childbearing potential (i.e., women with functioning ovaries and no documented
impairment of oviductal or uterine function that would cause sterility). This category
includes women with oligomenorrhoea (even severe), women who are
perimenopausal, and young women who have begun to menstruate. Women of
childbearing potential must have a negative serum pregnancy test at screening, and
agree to use a form of contraception as laid out in the protocol.
11. Able to swallow and retain oral medication;
12. Cardiac ejection fraction within the institutional range of normal as measured by
echocardiogram. Subjects with known history of uncontrolled or symptomatic
angina, arrhythmias, or congestive heart failure are not eligible;
13. Subjects must complete all screening assessments as outlined in the protocol.
14. Have adequate organ function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Malabsorption Syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded;
2. 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;
3. Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety;
4. Active or uncontrolled infection;
5. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
6. 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 enrolment. Routine screening
with CNS imaging studies is required only if clinically indicated or if the subject has a history of CNS metastases;
7. Peripheral neuropathy of grade 3 or higher;
8. Concurrent cancer therapy (chemotherapy, radiation therapy, surgery,
immunotherapy, biologic therapy, hormonal therapy, and tumor embolization).
9. Concurrent treatment with an investigational agent or participation in another clinical trial;
10. Use of an investigational drug within 30 days or 5 half-lives, whichever is longer,
preceding the first dose of study medication;
11. Prior exposure to pemetrexed or an EGFR inhibitor in combination with 5-FU or a
5FU prodrug.
12. The subject has a known immediate or delayed hypersensitivity reaction or
idiosyncrasy to drugs chemically related to lapatinib or Alimta.
13. Patient taking any prohibited medications as defined in the protocol or concurrent medications as indicated in the pemetrexed data sheet, for eg, concomitant administration of nephrotoxic drugs or those drugs that are tubularly secreted (eg probenecid) could potentially result in delayed clearance of pemetrexed. Patients taking non-steroidal inflammatory drugs need to follow the guidelines as indicated in the data sheet.
14. Known dihydropyrimidine dehydrogenase deficiency.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified