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A Phase 2 Multicenter Trial Comparing Two Schedules of GW572016 as First or Second Line Monotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer With Either Bronchioloalveolar Carcinoma or No Smoking History

Phase 2
18 Years
Not Enrolling
Non-Small-Cell Lung Cancer, Lung Cancer, Non-Small Cell

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Trial Information

A Phase 2 Multicenter Trial Comparing Two Schedules of GW572016 as First or Second Line Monotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer With Either Bronchioloalveolar Carcinoma or No Smoking History

Inclusion Criteria:

- Signed informed consent;

- Subjects must have histologically confirmed advanced (incurable stage IIIB or IV
according to the International Staging System, [Mountain, 1997] Non-Small Cell Lung
Cancer (NSCLC) at primary diagnosis or relapsed after curative-intent surgery. Only
patients with either (1) the histological subtypes of adenocarcinoma with BAC
(Bronchioloalveolar) features or pure BAC (as defined by the 1999 World Health
Organization criteria) or, (2) never smokers (i.e. smoked <100 cigarettes in
lifetime) with any histology of NSCLC (squamous, adenocarcinoma, lifetime) with any
histology of NSCLC (squamous, adenocarcinoma,

- Patients can have had a maximum of 1 prior systemic therapy (chemotherapy or biologic
therapy) for NSCLC that ended at least 3 weeks prior to enrollment. Patients that
have had adjuvant cytotoxic chemotherapy that ended at least 3 months prior to
enrollment are eligible. Prior surgery and radiotherapy are permitted. Patients
should recover from acute side effects of radiation before enrollment (3-4 weeks).
Concurrent radiotherapy is prohibited;

- Archived tumor tissue available for evaluation of genetic and intra-tumoral protein
or mRNA expression levels of relevant biomarkers. A minimum of 10 slides of archived
tumor tissue is required; however, 15 slides should be sent, if available. For
patients diagnosed on the basis of pleural effusions, efforts should be made to
provide as many slides as possible made with cells obtained from pleural aspirates.
Results of biomarkers will not be used to determine subject eligibility for the

- Measurable lesion(s) according to RECIST (e.g., ≥15 mm with conventional techniques
(medical photograph [skin or oral lesion], palpation, plain X-ray, CT, MRI, or ≥10 mm
with spiral CT scan);

- 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;

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1;

- Life expectancy of ≥ 12 weeks;

- ≥ 18 years old;

- 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 oligomenorrhea (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 1 of
the following: a Complete abstinence from intercourse from 2 weeks prior to
administration of the first dose of GW572016 until 28 days after the final dose of
GW572016; or b Consistent and correct use of 1 of the following acceptable methods of
birth control: 1. Male partner who is sterile prior to the female subject's entry
into the study and is the sole sexual partner for that female subject; or 2. Implants
of levonorgestrel 3. Injectable progestogen 4. Any intrauterine device (IUD) with a
documented failure rate of less than 1% per year; or 5. Oral contraceptives (either
combined or Progestogen only) 6. Barrier methods including diaphragm or condom with a

- Able to swallow and retain oral medication;

- Cardiac ejection fraction within the institutional range of normal as measured by
echocardiogram. Subjects with known history of uncontrolled or symptomatic
echocardiogram. Subjects with known history of uncontrolled or symptomatic angina,
arrhythmias, or congestive heart failure are not eligible;

- Have adequate organ function as defined in Table 1 Baseline Laboratory Values for

- Subjects must complete all screening assessments as outlined in the protocol.

Exclusion Criteria:

- Malabsorption Syndrome, disease significantly affecting gastrointestinal function, or
resection of the stomach or small bowel. Subjects with ulcerative colitis are also

- 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;

- 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;

- Unresolved or unstable, serious toxicity from prior administration of another
investigational drug;

- Active or uncontrolled infection;

- Dementia, altered mental status, or any psychiatric condition that would prohibit the
understanding or rendering of informed consent;

- Uncontrolled angina, arrhythmias, or congestive heart failure. Patients whose
symptoms are under control 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. Routine screening with CNS
imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is
required only if clinically indicated or if the subject has a history of CNS

- Concurrent cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy,
biologic therapy, hormonal therapy, and tumor embolization).

- Concurrent treatment with an investigational agent or participation in another
clinical trial

- Use of an investigational drug within 30 days or 5 half-lives, whichever is longer,
preceding the first dose of GW572016;

- Prior therapy with any ErbB1 and/or ErbB2 inhibitor;

- The subject has a known immediate or delayed hypersensitivity reaction or
idiosyncrasy to drugs chemically related to GW572016.

- Has taken/received the following inhibitors of CYP3A4 within the specified number of
days prior to the first dose of study medication: Seven (7) days: antibiotics
(clarithromycin, erythromycin, troleandomycin), antiretrovirals (delavirdine),
protease inhibitors (ritonavir, indinavir, saquinavir, nelfinavir, amprenavir,
lopinavir), systemic antifungals (itraconazole, ketoconazole, voriconazole,
fluconazole (doses of 200 mg/day and above)), antidepressants (nefazodone,
fluovoxamine), calcium channel blockers (verapamil, diltiazem), gastrointestinal
(cimetidine, aprepitant), and grapefruit or its juice. Six (6) months: amiodarone.

- Has taken/received the following inducers of CYP3A4 within fourteen (14) days prior
to the first dose of study medication: glucocorticoids (dexamethasone or
dexamethasone equivalent dose > 1.5mg/day (see chart in Section 7.2 for conversion),
anticonvulsants (phenytoin, carbamazepine, phenobarbital), efavirenz, nevirapine,
antibiotics (rifampin (rifampicin), rifabutin, rifapentine), St. John's Wort and

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor Response in the Targeted Population Through the End of Treatment

Outcome Description:

Disease progression and tumor response (number of participants achieving a complete response [CR] or partial response [PR]), using standardized criteria (Response evaluation criteria in solid tumors). CR, disappearance of all target lesions; PR, 30% decrease in the sum of the longest diameter of target lesions; progressive disease, 20% increase in the sum of the longest diameter of target lesions; stable disease, small changes that do not meet above criteria. Disease assessment was done at baseline and then every 8 weeks after starting treatment, until the participant discontinued treatment.

Outcome Time Frame:

Baseline and then every 8 weeks through end of treatment

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

November 2003

Completion Date:

July 2008

Related Keywords:

  • Non-Small-Cell Lung Cancer
  • Lung Cancer, Non-Small Cell
  • EGFR
  • ErbB1
  • ErbB2
  • metastatic
  • lapatinib
  • Her-2/neu
  • protein kinase inhibitor
  • BAC
  • GW572016
  • Advanced
  • Adenocarcinoma, Bronchiolo-Alveolar
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



GSK Investigational Site Bakersfield, California  93309
GSK Investigational Site New Orleans, Louisiana  70112
GSK Investigational Site Albuquerque, New Mexico  87109
GSK Investigational Site Raleigh, North Carolina  27609
GSK Investigational Site Akron, Ohio  44304
GSK Investigational Site Fort Worth, Texas  76104
GSK Investigational Site Park Ridge, Illinois  60068
GSK Investigational Site Pittsburgh, Pennsylvania  15213
GSK Investigational Site Germantown, Tennessee  38138
GSK Investigational Site New York, New York  10021
GSK Investigational Site Birmingham, Alabama  35209
GSK Investigational Site Washington, District of Columbia  20307-5001
GSK Investigational Site Edison, New Jersey  08837
GSK Investigational Site Oregon City, Oregon  97045