A RANDOMIZED PHASE 2 TRIAL OF PF 00299804 VERSUS ERLOTINIB FOR THE TREATMENT OF ADVANCED NON SMALL CELL LUNG CANCER AFTER FAILURE OF AT LEAST ONE PRIOR CHEMOTHERAPY REGIME

Phase 1

• Conditions: on-Small cell Lung Cancer; MedDRA version: 9.1 Level: LLT Classification code 10061873 Term: Non-small cell lung cancer

• Registration Number: EUCTR2008-005235-14-GB
• Lead Sponsor: PFIZER INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-22
• Study Completion: 2014-08-15
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 187

Inclusion Criteria

Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study.
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1. Provision of a personally signed and dated voluntary written informed consent
document;
2. Age >/=18 years, male or female;
3. Evidence of histologically confirmed, advanced NSCLC;
a. For the purpose of randomization/ stratification the histologic subtype of NSCLC must be documented, preferably by WHO criteria
b. The diagnosis of NSCLC NOS (not otherwise specified) will not be sufficient for enrollment and randomization/stratification.
4. In general, specimen from diagnostic or recently obtained tumor tissue is to be sent to the Sponsor-designated central laboratory for KRAS mutation testing. Patients who have had KRAS testing previously at a sponsor approved laboratory are allowed to enroll if they meet all other eligibility criteria, and if tissue is sent from the site to the Sponsor designated central lab for independent confirmation of the KRAS test result:
a. for KRAS testing, the availability of paraffin block or unstained slides is preferred, but fine needle aspirate material can also be accepted.
b. For patients who have prior KRAS testing, a specimen for exploratory analysis of circulating tumor KRAS DNA in blood is still required, as per the trial objectives and endpoints.
5. ECOG 0-2 performance status;
6. Evidence of progressive disease after at least one and no more than two prior chemotherapy regimens for advanced disease; patients who completed prior adjuvant or combined modality therapy for regional disease within 12 months may be enrolled if they have received only one chemotherapy regimen for advanced disease:
a. For the purpose of this study, chemotherapy regimen is defined as any chemotherapeutic agent(s) accepted as standard of care. In addition, prior investigational therapy will be counted as one regimen of systemic therapy, and such patients can therefore only be enrolled if they have received only one regimen of standard chemotherapy. Patients who have received investigational therapy as the only prior treatment for advanced NSCLC may not be enrolled.
7. Any prior treatment (chemotherapy, radiation or surgery) must have been completed at least 2 weeks prior to randomization. Any acute toxicity must have been recovered to Grade 1 (per NCI CTCAE v3.0.1) or baseline;
8. Measurable disease by RECIST criteria: a. At least one target lesion, that has not previously been radiated, measurable in at least one dimension of greater than 2 cm by conventional CT or MRI, or at least 10 mm by spiral CT, must be present;
b. Palpable disease which is biopsy proven to be metastatic NSCLC (eg, skin nodule or lymphadenopathy), superficial, and measurable by caliper is allowed, though confirmation of measurement by CT or ultrasound is encouraged;
c. Acceptable radiologic procedures for disease assessment include contrast enhanced conventional or spiral CT, or MRI; contrast enhanced scans are required
in the absence of contrast-allergy and patient intolerance of MR

Exclusion Criteria

Patients presenting with any of the following will not be included in the trial.
1. Any evidence of mixed histology that includes elements of small cell or carcinoid lung cancer;
2. Patients with known leptomeningeal metastases, or symptomatic brain metastases. (Screening CNS imaging in asymptomatic patients is not a required trial procedure.) Patients with previously diagnosed brain metastases for which treatment (radiation or surgery) is recommended in the judgment of investigator are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to the start of study medication, have discontinued corticosteroid treatment for these metastases for at least 2 weeks, and are neurologically stable;
3. Chemotherapy, radiotherapy (other than palliative radiotherapy to lesions that will not be followed for tumor assessment on this study, ie, non target lesions), biological or investigational agents within 2 weeks of baseline disease assessments;
4. Prior therapy with an agent that is known or proposed to be active by action on: EGFR tyrosine kinase or other HER family proteins including but not limited to erlotinib (Tarceva®), gefitinib (Iressa®), lapatinib (Tykerb®), cetuximab (Erbitux®), panitumumab (Vectibix®), trastuzumab (Herceptin®), ZD6474 (Zactima®), cantertinib (CI-1033), HKI-272, BIBW-2992, XL-647, AEE788, matuzumab, and pertuzumab;
5. Any surgery (not including minor procedures such as lymph node biopsy) within 4 weeks of baseline disease assessments; or not fully recovered from any side effects of previous procedures;
6. Any clinically significant gastrointestinal abnormalities, which may impair intake, transit or absorption of the study drug, such as the inability to take oral medication in tablet form;
7. Current enrollment in another therapeutic clinical trial;
8. Any psychiatric or cognitive disorder that would limit the understanding or rendering of informed consent and/or compromise compliance with the requirements of this protocol;
9. Patients with known interstitial lung disease
10. Uncontrolled or significant cardiovascular disease, including:
a. Myocardial infarction within 12 months;
b. Uncontrolled angina within 6 months;
c. Congestive heart failure within 6 months or left ventricular ejection fraction below local institutional lower limit of normal or below 50%;
d. Diagnosed or suspected congenital long QT syndrome;
e. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes);
f. Prolonged QTc interval on pre entry electrocardiogram. QTc must be of less than CTC Grade 2 (=470 msec) using appropriate correction formula with manual read by investigator if required. The ECG may be repeated for evaluation of eligibility after management of correctable causes for observed QTc prolongation;
g. Any history of second or third degree heart block (may be eligible if currently have a pacemaker);
h. Heart rate <50/minute on baseline electrocardiogram;
i. Uncontrolled hypertension.
11. Prior malignancy: Patients will not be eligible if they have e

Study & Design

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