Active — Not RecruitingPhase 3

A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC)

China187 participantsStarted 2016-08-03

Plain-language summary

This randomized, multicenter, Phase III, open-label study will evaluate the efficacy and safety of alectinib versus crizotinib and to evaluate the pharmacokinetics of alectinib in asian participants with treatment-naive ALK-positive advanced NSCLC. Participants will be randomized 2:1 into one of the two treatment groups to receive either alectinib (600 milligrams \[mg\] twice daily \[BID\]) or crizotinib (250 mg BID) orally, respectively.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 available to perform ALK IHC is required. Ventana IHC testing will be performed at the designated central laboratory * Life expectancy of at least 12 weeks * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2 * No history of receiving systemic treatment for advanced, recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC * Adequate hematologic function: Platelet count greater than equal to (\>=) 100×10\^9 per liter (/L); absolute neutrophil count (ANC) \>=1500 cells per microliter (cells/mcL); hemoglobin\>=9.0 grams per deciliter (g/dL) * Adequate renal function: an estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease (MDRD) formula of \>=45 milliliters per minute per 1.73 square meter * Participants must have recovered from effects of any major surgery or significant traumatic injury at least 28 days before receiving the first dose of study treatment * Measurable disease (by Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\]) before administration of study treatment * Previous brain or leptomeningeal metastases are allowed if the participant is asymptomatic (e.…

What they're measuring

Progression-Free Survival (PFS) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumor (RECIST) v1.1

Timeframe: From the date of randomization to the date of the first documented disease progression or death, whichever occurred first (up to overall period of approximately 40 months)

Trial details

NCT IDNCT02838420

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-05-31

Results submitted2019-05-29

View on ClinicalTrials.gov More Anaplastic Lymphoma Kinase-positive Non-small Cell Lung Cancer trials