A Study of the Efficacy and Safety of Alectinib in Partic... | NCT03155009

ID	Type	Description	Link
2016-003924-22	EudraCT Number

Status Module

Label	Type	Description	Intervention Names
Alectinib	Experimental	600 mg orally twice daily (BID) for up to 2 years	Drug: Alectinib

Name	Type	Description	Arm Group Labels	Other Names
Alectinib	Drug	600 mg orally BID with food	Alectinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR)	ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) assessed by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST), v.1.1. CR is defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 mm in short axis. PR is defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions.	Up to 2 years

Secondary Outcomes

Measure	Description	Time Frame
Central Nervous System Objective Response Rate (C-ORR)	C-ORR is defined as the percentage of participants who attain a CR or PR of the baseline CNS metastases based on RECIST v.1.1. CR is defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 mm in short axis. PR is defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions.

Eligibility Module

Eligibility Criteria

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).

Facility	Status	City	State	ZIP	Country	Contacts
CHU Angers		Angers		49933	France
Hopital Jean Minjoz; Pneumologie

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases