A Randomized, Double-Blind, Phase 3 Study of PF-00299804 versus Erlotinib in the Treatment of Advanced Non-Small Lung Cancer
- Conditions
- on-small cell lung cancerMedDRA version: 14.0Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-022656-22-GR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 800
Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study (additional details can be found in the protocol, Section 4.1):
1. Provision of a voluntarily given, personally signed, and dated written informed consent document;
2. Age =18 years, male or female;
3. Evidence of pathologically confirmed, advanced NSCLC for which there is no curative standard therapy in the judgment of the investigator;
a. For randomization/ stratification, the histologic subtype of NSCLC must be documented;
b. Diagnosis of NSCLC NOS (not otherwise specified) will not be sufficient for enrollment and randomization/stratification.
4. Specimen from archival or recently obtained tumor tissue is required, and will be sent to the Sponsor-designated central laboratory for molecular testing of tumor tissue, including KRAS mutation status, and HER family testing (as available tissue allows);
5. ECOG 0-2 performance status;
6. Prior treatment with at least one and no more than two regimens of systemic therapy which include at least one standard chemotherapy for advanced NSCLC;
7. Any prior treatment (chemotherapy, radiation or surgery) must have been completed at least 2 weeks prior to randomization. Any acute toxicity related to prior therapy must have been recovered to Grade 1 (per NCI CTCAE v4) or baseline;
8. Radiologically measurable disease by RECIST v1.1 criteria:
a. At least one target lesion, that has not previously been radiated, and measurable as per RECIST (Appendix 4 of the protocol);
b. 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 MRI. The following are not allowed as sole documentation of target lesions: CT component of a Positron Emission Tomography/CT, ultrasound alone, nuclear scans (including bone or PET scans), plain CXR or bone radiographs, and tumor markers.
9. Brain metastases treated with radiation or surgery are allowed if radiologically and neurologically stable and the subject is off corticosteroids for at least 2 weeks prior to randomization;
10. Adequate Renal Function, including:
a. Estimated creatinine clearance =15 mL/min (as determined by site’s standard formula);
b. No known history of renal papillary necrosis or pyelonephritis.
11. Adequate Liver Function, including:
• Bilirubin = 1.5 x upper limit of normal (ULN);
• AST (SGOT) or ALT (SGPT) = 2.5 x ULN (= 5.0 x ULN if hepatic metastases);
12. Female patients or their partners must be surgically sterile or be postmenopausal (defined as 12 months of amenorrhea following last menses), or must agree to use effective contraception while receiving trial treatment and for at least 3 months thereafter. (The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. Where advised by investigator, double barrier contraception is defined as condom plus spermicide in combination with a female condom, diaphragm, cervical cap or intrauterine device).
13. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within 72 hours prior to starting treatment.
14. Male patients or their partners must be surgically sterile or must agree to use effective contraception while receiving trial treatment and for at least 3 months thereafter. The definition of effect
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. 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), neratinib (HKI 272), Tovok (BIBW 2992), XL 647, AEE788, matuzumab, and pertuzumab.
5. Investigational therapy as only treatment for advanced NSCLC, without administration of an approved chemotherapy for advanced NSCLC.
6. Any surgery (not including minor procedures such as lymph node biopsy) within 2 weeks of baseline disease assessments; or not fully recovered from any side effects of previous procedures.
7. Any clinically significant gastrointestinal abnormalities, which may impair intake, transit or absorption of the study drug, such as the inability to take oral medication.
8. Current enrollment in another therapeutic clinical trial.
9. Any psychiatric or cognitive disorder that would limit the understanding or rendering of informed consent and/or compromise compliance with the requirements of this study.
10. Patients with known diffuse interstitial lung disease.
11. 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;
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 less than CTC Grade 2 (=480 msec) using Fredricia’s 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.
12. Prior malignancy: Patients will not be eligible if they have evidence of other malignancy (other than non melanoma skin cancer or in situ cervical cancer, or localized and presumed cured prostate cancer with Prostate Specific Antigen (PSA) < ULN) within the last 3 years.
13. Other severe acute or chronic medical condition that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method