Study with investigational drug PF-06463922 and comparator crizotinib in patients with a specific type of advanced lung cancer
- Conditions
- Advanced ALK positive non small cell lung cancerMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-003315-35-IT
- Lead Sponsor
- PFIZER INC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 280
1. Diagnosis:
a. Study Population: Patients with histologically or cytologically confirmed diagnosis of locally advanced (Stage IIIB not amenable for multimodality
treatment) or metastatic (Stage IV) ALK-positive NSCLC where ALK status is determined by the FDA-approved (for use in US), CE (Conformité Européene)
marked (for EU and other countries that accept CE marking), and PMDA(Pharmaceuticals and Medical Devices Agency)-approved (for use in
Japan) Ventana ALK (D5F3) Companion Diagnostic (CDx) IHC test performed on the Ventana ULTRA or XT platforms (refer to Section 6.1.1.1 for any prescreening activity related to ALK determination);
b. Tumor Requirements: At least 1 extracranial measurable target lesion per RECIST v. 1.1 that has not been previously irradiated. CNS metastases are
allowed if asymptomatic and:
i. Either untreated and not currently requiring corticosteroid treatment, or on a stable or decreasing dose of =10 mg QD prednisone or equivalent; or
ii. Local treatment has been completed with full recovery from the acute effects of radiation therapy or surgery prior to randomization, and if corticosteroid
treatment for these metastases has been withdrawn for at least 4 weeks with neurological stability; or
iii. In case of leptomeningeal disease (LMD) or carcinomatous meningitis (CM) if visualized on magnetic resonance imaging (MRI) , or if baseline CSF
positive cytology is available.
c. Tissue Requirements: All patients must have an archival formalin fixed, paraffin embedded (FFPE) tissue specimen available and collected prior to randomization.
If archived tissue is unavailable, then a mandatory de novo biopsy must be performed.
2. No prior systemic NSCLC treatment for advanced (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) disease, including molecularly
targeted agents (eg, ALK TKIs), angiogenesis inhibitors, immunotherapy, or chemotherapy. Prior treatment for earlier Stages of the NSCLC only allowed if
completed more than 12 months prior to randomization.
3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, 1, or 2.
4. Age =18 years (or =20 years as required by local regulation).
5. Adequate Bone Marrow Function, including:
a. Absolute Neutrophil Count (ANC) = 1,500/mm3 or =1.5 x 109/L;
b. Platelets =100,000/mm3 or =100 x 109/L;
c. Hemoglobin =9 g/dL.
6. Adequate Pancreatic Function, including:
a. Serum total amylase =1.5 x upper limit of normal (ULN)*;
b. Serum lipase =1.5 x ULN.
*if total amylase >1.5 x ULN, but pancreatic amylase is within the ULN, then patient may be
enrolled.
7. Adequate Renal Function, including:
a. Serum creatinine =1.5 x ULN or estimated creatinine clearance =60 mL/min as calculated using the method standard for the institution.
8. Adequate Liver Function, including:
a. Total serum bilirubin =1.5 x ULN;
b. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) =2.5 x ULN (=5.0 x ULN in case of liver metastases).
9. Acute effects of prior radiotherapy resolved to baseline severity or to CTCAE Grade =1 except for AEs that in the investigator’s judgment do not constitute a safety risk
for the patient.
10. Serum pregnancy test (for females of childbearing potential) negative at screening. Female patients of non-childbearing potential must meet at least 1 of the following
criteria:
- Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or
physiological
1. Spinal cord compression unless the patient has good pain control attained through therapy, and there is stabilization or recovery of neurological function for the 4 weeks
prior to randomization.
2. Major surgery within 4 weeks prior to randomization. Minor surgical procedures (eg, port insertion) are not excluded, but sufficient time should have passed for adequate
wound healing.
3. Radiation therapy within 2 weeks prior to randomization, including stereotactic or partial brain irradiation. Patients who complete whole brain irradiation within
4 weeks prior to randomization or palliative radiation therapy outside of the CNS within 48 hours prior to randomization will also not be included in the study.
4. Gastrointestinal abnormalities, including inability to take oral medication; requirement for intravenous alimentation; prior surgical procedures affecting
absorption including total gastric resection or lap band; active inflammatory gastrointestinal disease, chronic diarrhea, symptomatic diverticular disease; treatment
for active peptic ulcer disease in the past 6 months; malabsorption syndromes.
5. Known prior or suspected severe hypersensitivity to study drugs or any component in their formulations.
6. Active and clinically significant bacterial, fungal, or viral infection including hepatitis B virus (HBV) or hepatitis C virus (HCV) (eg, in case of known HBsAg or HCV
antibody positivity), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness.
7. Clinically significant vascular (both arterial and venous) and non-vascular cardiac conditions, (active or within 3 months prior to enrollment), which may include, but
are not limited to:
¿ Arterial disease such as cerebral vascular accident/stroke (including Transient Ischemic Attack -TIA), myocardial infarction, unstable angina;
¿ Venous diseases such as cerebral venus thrombosis, symptomatic pulmonary embolism;
¿ Non-vascular cardiac disease such as congestive heart failure (New York Heart Association Classification Class = II), second-degree or third-degree AV block
(unless paced) or any AV block with PR >220 msec; or ongoing cardiac dysrhythmias of NCI CTCAE Grade =2, uncontrolled atrial fibrillation of any
grade, bradycardia defined as <50 bpm (unless patient is otherwise healthy such as long-distance runners, etc.), machine-read Electrocardiogram (ECG) with QTc
>470 msec, or congenital long QT syndrome.
8. Patients with predisposing characteristics for acute pancreatitis according to investigator judgment (eg, uncontrolled hyperglycemia, current gallstone disease) in
the last month prior to randomization.
9. History of extensive, disseminated, bilateral or presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity
pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis.
10. Evidence of active malignancy (other than NSCLC, non-melanoma skin cancer, or localized prostate cancer or any in situ cancer which does not currently require
treatment) within the last 3 years prior to randomization.
Please refer to the protocol for complete list of exclision citeria.
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