A Study of the Efficacy and Safety of Alectinib in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (ATALK)

Roche

Status and phase

Completed

Phase 2

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: Alectinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT03155009

2016-003924-22 (EudraCT Number)

ML39349

Details and patient eligibility

About

This study will evaluate the efficacy and safety of alectinib, in selected participants, with anaplastic lymphoma kinase-rearranged (ALK-rearranged) non-small cell lung cancer (NSCLC), after disease progression on prior treatment strategy with crizotinib, as only ALK inhibitor, and eventually chemotherapy treatment(s).

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants with histologically or cytologically confirmed locally advanced or metastatic NSCLC (Stage IIIB or IV accordingly to American Joint Committee on Cancer [AJCC] classification)
Life expectancy of at least 12 weeks, in the opinion of the Investigator
Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2
Having contributive biopsy performed on fresh tissue (FFPE blocks required) taken after progression on previous therapy showing presence of anaplastic lymphoma kinase (ALK) rearrangement, assessed by immunohistochemistry (IHC) and confirmed by fluorescence in situ hybridization (FISH)
Absence of resistance mechanism to alectinib assessed by the Biomarkers Board
Disease progression, limited to central nervous system (CNS) without possibility of tissue biopsy
Non-contributive molecular analyses (not enough tumor cells or deoxyribonucleic acid, [DNA] amount or failure of analyses for technical reasons): inclusion is at investigator discretion (decision made upon Biomarker Board recommendation)
History of crizotinib exposure
Washout period: if previous progression on crizotinib: 7 days from last intake of the drug
If previous progression on chemotherapy: 28 days
If previous radiation therapy: 15 days
Participants must have recovered from treatment toxicities to ≤ Grade 1 or to their pretreatment levels (for participants who have developed interstitial lung disease [ILD], they must have fully recovered)
Recovery from effects of any major surgery, or significant traumatic injury, at least 35 days before the first dose of alectinib
Adequate hematologic function
Adequate renal function
For all females of childbearing potential, a negative pregnancy test must be obtained within three days before starting study drug
For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of < 1% per year, during the treatment period and for at least 90 days after the last dose of study drug
For men: agreement to remain abstinent or use a barrier method of contraception (e.g., condom) during the treatment period and for at least 90 days after the last dose of study drug and agreement to refrain from donating sperm during this same period
Participant has national health insurance coverage

Exclusion criteria

Prior therapy with other ALK inhibitors than crizotinib (including alectinib)
Participants with symptomatic CNS metastases who are neurologically unstable or require increasing doses of steroids within one week prior to Day 0 to manage CNS symptoms
Participants with progression limited to CNS and eligible to a focal treatment (surgery or stereotaxic radiotherapy)
Administration of strong/ potent cytochrome P450 3A (CYP3A) inhibitors or inducers, or agents with potential QT prolonging effects within 14 days prior to first administration of study drug
Liver disease
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 investigator, pose an unacceptable risk to the participant in this study
Active or uncontrolled infectious diseases requiring treatment
History of organ transplant
Participants with baseline QTc > 470 ms or participants with symptomatic bradycardia
Pregnant or lactating women
History of hypersensitivity to any of the additives in the alectinib drug
Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the participant before trial entry
Serious, uncontrolled infections or current known infection with human immunodeficiency virus (HIV).