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A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)

A Phase I/II Study of the ALK Inhibitor CH5424802/ RO5424802 in Patients With ALK-Rearranged Non-Small Cell Lung Cancer Previously Treated With Crizotinib

NCT01871805•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This non-randomized, open-label, multicenter study will evaluate the safety and efficacy of alectinib in participants with ALK-rearranged non-small cell lung cancer who failed crizotinib treatment. In Phase I, cohorts of participants will receive escalating doses of alectinib orally twice daily. In Phase II, patients who failed crizotinib treatment will receive the recommended phase II dose.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed, locally advanced, not amenable to curative therapy, or metastatic NSCLC
•ALK-rearrangement confirmed by the Food and Drug Administration (FDA) approved test
•NSCLC that has failed crizotinib treatment
•Measurable disease as defined by RECIST v1.1
•Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\<=) 2
•Adequate hematologic, hepatic and renal function

Exclusion Criteria

•Prior therapy with ALK inhibitor other than crizotinib
•Brain or leptomeningeal metastases that are symptomatic and/or requiring treatment
•History of serious cardiac dysfunction
•History of or current active infection with hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
•Clinically significant gastrointestinal abnormality that would affect absorption of the drug
•Pregnant or lactating women

Locations (42)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of California Irvine

Irvine, California, United States

UCSD Moores Cancer Center

La Jolla, California, United States

Loma Linda Cancer Center

Loma Linda, California, United States

UCLA

Los Angeles, California, United States

Univ of Colorado Canc Ctr

Aurora, Colorado, United States

National Jewish Health

Denver, Colorado, United States

Lynn Regional Cancer Center West

Boca Raton, Florida, United States

Florida Hospital Cancer Inst

Orlando, Florida, United States

UF Health Orlando

Orlando, Florida, United States

Key Dates

Start Date

September 30, 2013

Primary Completion Date

October 24, 2014

Completion Date

August 31, 2017

Last Updated

August 21, 2018

Enrollment

134

ACTUAL participants

Conditions

Non-Small Cell Lung Cancer

Interventions

Alectinib

DRUG

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

View study

RECRUITINGPHASE3

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 21, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)