Alectinib versus crizotinib in previously untreated patients with advanced ALK positive non-small cell lung cancer
- Conditions
- ALK-positive non-small cell lung cancerMedDRA version: 18.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-004133-33-DE
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 286
•Histologically or cytologically confirmed diagnosis of advanced or
recurrent (Stage IIIB not amenable for multimodality treatment) or
metastatic (Stage IV) NSCLC that is ALK-positive as assessed by the
Ventana immunohistochemistry (IHC) test. Sufficient tumor tissue to
perform ALK IHC and ALK fluorescent in situ hybridization (FISH) is
required. Both tests will be performed at designated central laboratories.
•Measurable disease (by Response Evaluation Criteria In Solid Tumors
[RECIST] v1.1) prior to the administration of study treatment.
•Patients had no prior systemic treatment for advanced or recurrent
(Stage IIIB not amenable for multimodality treatment) or metastatic
(Stage IV) NSCLC.
•Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
of 0-2.
•Adequate hematologic, renal and liver function.
•Able and willing to provide written informed consent prior to
performing any study related procedures and to comply with the study
protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46
•Any GI disorder that may affect absorption of oral medications, such as
mal absorption syndrome or status post-major bowel resection.
•Administration of strong/potent cytochrome P4503A inhibitors or
inducers within 14 days prior to the first dose of study treatment and
while on treatment with alectinib or crizotinib
•Administration of agents with potential QT interval prolonging effects
within 14 days prior to the first administration of study drug and while
on treatment.
•History of hypersensitivity to any of the additives in the alectinib drug
formulation
•History of hypersensitivity to any of the additives in the crizotinib drug
formulation
•Any clinically significant concomitant disease or condition that could
interfere with, or for which the treatment might interfere with, the
conduct of the study or the absorption of oral medications or that would,
in the opinion of the Principal Investigator, pose an unacceptable risk to
the patient in this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Investigator assessed progression-free survival (PFS);Secondary Objective: PFS by the IRC; time to CNS progression; Objective Response Rate (ORR) and Duration of Response (DOR); time to deterioration (TTD) in patient-reported lung cancer symptoms; health-related quality of life (HRQoL); safety and tolerability; pharmacokinetics of alectinib and metabolite(s); overall survival (OS).;Primary end point(s): •PFS, as assessed by investigator<br>;Timepoint(s) of evaluation of this end point: The time from date of randomization to the date of first documented disease progression (as per RECIST 1.1) or death, whichever occurs first
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •PFS by IRC<br>•Time to CNS Progression<br>•ORR<br>•Time to deterioration (TTD) in patient-reported lung cancer symptoms<br>•Health-related quality of life (HRQoL)<br>•Safety and tolerability<br>•Pharmacokinetics of alectinib and metabolite(s)<br>•Overall survival (OS);Timepoint(s) of evaluation of this end point: •The same methodology as specified for PFS<br>•The time from randomization until radiographic evidence of CNS progression<br>•The percentage of patients who attain a CR or PR (as per RECIST 1.1) <br>•From baseline until disease progression and during post-progression on treatment in case of isolated, asymptomatic CNS progression; and at survival follow-up for 6 months<br>•From baseline until disease progression and during post-progression on treatment in case of isolated, asymptomatic CNS progression; and at survival follow-up for 6 months<br>•Throughout the study<br>•Until disease progression<br>•The time from the date of randomization to the date of death due to any cause