A Phase 3 Multicenter Open-label Study of Brigatinib (AP26113) versus Crizotinib in Patients with ALK-positive Advanced Lung Cancer
- Conditions
- longaandoeningenALK-positive Advanced Non-Small Cell Lung Cancer
- Registration Number
- NL-OMON50594
- Lead Sponsor
- ARIAD Pharmaceuticals, Inc. (a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
1. Have histologically or cytologically confirmed stage IIIB (locally advanced
or recurrent and not a
candidate for definitive multimodality therapy) or stage IV NSCLC.
2. Patient must meet one of the following two criteria:
a. Have documentation of ALK rearrangement by a positive result from the Vysis®
ALK Break-Apart fluorescence in situ hybridization (FISH) Probe Kit or the
Ventana ALK (D5F3) CDx Assay. The test must have been performed according to
the product*s instructions for use (IFU).
b. Have documented ALK rearrangement by a different test and adequate tissue
available for central laboratory testing by an FDA-approved test. Confirmation
of central test positivity is not required prior to randomization.
3. Have sufficient tumor tissue available for central analysis
4. Have at least 1 measurable (i.e., target) lesion per RECIST v1.1
5. Recovered from toxicities related to prior anticancer therapy to NCI CTCAE
v 4.0 grade *1. Note: treatment-related alopecia or peripheral neuropathy that
are grade >1 are allowed if deemed irreversible
6. Are a male or female patient *18 years old.
7. Have adequate organ function, as defined by the study protocol
8. Have Eastern Cooperative Oncology Group (ECOG) performance status *2
9. Have normal QT interval on screening ECG evaluation, defined as QT
interval corrected (Fridericia) (QTcF) of *450 milliseconds (msec) in males
or *470 msec in females.
10. For female patients of childbearing potential, have a negative pregnancy
test
documented prior to randomization.
11. For female and male patients who are fertile, agree to use a highly
effective
form of contraception with their sexual partner during the dosing period and
for a period of at least 4 months after the end of treatment with brigatinib
and at least 3 months after the end of treatment with crizotinib, as defined by
the study protocol
12. Provide signed and dated informed consent indicating that the patient has
been informed of all pertinent aspects of the study, including the potential
risks, and is willingly participating.
13. Have the willingness and ability to comply with scheduled visit and study
procedures.
1. Previously received an investigational antineoplastic agent for NSCLC.
2. Previously received any prior TKI, including ALK-targeted TKIs.
3. Previously received more than 1 regimen of systemic anticancer therapy for
locally advanced or metastatic disease.
4. Received chemotherapy or radiation within 14 days of first dose of study
drug, except stereotactic radiosurgery (SRS) or stereotactic body radiation
therapy (SBRT).
5. Received anti-neoplastic monoclonal antibodies within 30 days of the first
dose of study drug.
6. Had major surgery within 30 days of the first dose of study drug, minor
surgical procedures such as catheter placement or minimally invasive biopsies
are allowed.
7. Have been diagnosed with another primary malignancy other than NSCLC, except
for adequately treated non-melanoma skin cancer or cervical cancer in situ;
definitively treated non-metastatic prostate cancer; or patients with another
primary malignancy who are definitively relapse-free with at least 3 years
elapsed since the diagnosis of the other primary malignancy.
8. Have symptomatic CNS metastases (parenchymal or leptomeningeal) at screening
or asymptomatic disease requiring an increasing dose of corticosteroids to
control symptoms within 7 days prior to randomization.
9. Have current spinal cord compression (symptomatic or asymptomatic and
detected by radiographic imaging). Patients with leptomeningeal disease and
without cord compression are allowed.
10. Be pregnant, planning a pregnancy, or breastfeeding
11. Have significant, uncontrolled, or active cardiovascular disease as defined
by the study protocol
12. Have uncontrolled hypertension.
13. Have a history or the presence at baseline of pulmonary interstitial
disease, drug-related pneumonitis, or radiation pneumonitis.
14. Have an ongoing or active infection
15. Have a known history of human immunodeficiency virus (HIV) infection.
16. Have a known or suspected hypersensitivity to brigatinib or its excipients
and/or crizotinib or its excipients.
17. Have malabsorption syndrome or other gastrointestinal (GI) illness or
condition
18. Have any condition or illness that, in the opinion of the investigator,
would
compromise patient safety or interfere with the evaluation of the study drug.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>PFS, as assessed by the BIRC, per RECIST v1.1 (Eisenhauer et al, 2009)</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Confirmed ORR, as assessed by the BIRC, per RECIST v1.1<br /><br>2. Confirmed intracranial ORR as assessed by the BIRC<br /><br>3. Intracranial PFS, as assessed by the BIRC<br /><br>4. OS<br /><br>5. Duration of response, as assessed by the BIRC<br /><br>6. Time to response, as assessed by the BIRC<br /><br>7. Disease control rate, as assessed by the BIRC<br /><br>8. Safety and tolerability<br /><br>9. Change from baseline scores in global health status/quality of life (QOL),<br /><br>assessed with the EORTC QLQ-C30 (v3.0) and time-to-deterioration in dyspnea<br /><br>assessed with the EORTC QLQ-LC13 (v3.0)</p><br>