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Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Participants Previously Treated With Platinum-Based Chemotherapy and Crizotinib

NCT ID: NCT02604342

Last Updated: 2019-10-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-03

Study Completion Date

2018-08-13

Brief Summary

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This randomized active-controlled multicenter Phase III open-label study will evaluate and compare between treatment groups the efficacy of alectinib versus chemotherapy in participants with ALK-positive advanced NSCLC who were previously treated with chemotherapy and crizotinib, as measured by investigator-assessed progression-free survival (PFS) and to evaluate and compare between treatment groups the central nervous system (CNS) objective response rate (C-ORR) in participants with measurable CNS metastases at baseline, as assessed by an Independent Review Committee (IRC).

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Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Alectinib

Participants will receive oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food until disease progression, unacceptable toxicity, withdrawal of consent or death.

Group Type EXPERIMENTAL

Alectinib

Intervention Type DRUG

Participants will receive oral alectinib at a dose of 600 mg twice daily, taken with food until disease progression, unacceptable toxicity, withdrawal of consent or death.

Premetrexed/Docetaxel

Participants will receive chemotherapy with either pemetrexed (500 milligrams per square meter \[mg/m\^2\] of body surface area) or docetaxel (75 mg/m\^2) intravenously.

Group Type ACTIVE_COMPARATOR

Docetaxel

Intervention Type DRUG

Participants will receive docetaxel at a dose of 75 mg/m\^2 of body surface area intravenously every 3 weeks, until disease progression, unacceptable toxicity, withdrawal of consent or death.

Pemetrexed

Intervention Type DRUG

Participants will receive pemetrexed at a dose of 500 mg/m\^2 of body surface area intravenously every 3 weeks, until disease progression, unacceptable toxicity, withdrawal of consent or death.

Interventions

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Alectinib

Participants will receive oral alectinib at a dose of 600 mg twice daily, taken with food until disease progression, unacceptable toxicity, withdrawal of consent or death.

Intervention Type DRUG

Docetaxel

Participants will receive docetaxel at a dose of 75 mg/m\^2 of body surface area intravenously every 3 weeks, until disease progression, unacceptable toxicity, withdrawal of consent or death.

Intervention Type DRUG

Pemetrexed

Participants will receive pemetrexed at a dose of 500 mg/m\^2 of body surface area intravenously every 3 weeks, until disease progression, unacceptable toxicity, withdrawal of consent or death.

Intervention Type DRUG

Other Intervention Names

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Taxotere® Alimta®

Eligibility Criteria

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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. ALK positivity must have been determined by a validated fluorescence in situ hybridization (FISH) test (recommended probe, Vysis ALK Break-Apart Probe) or a validated immunohistochemistry (IHC) test (recommended antibody, clone D5F3)
* Participant had received two prior systemic lines of therapy, which must have included one line of platinum-based chemotherapy and one line of crizotinib
* Prior CNS or leptomeningeal metastases allowed if asymptomatic
* Participants with symptomatic CNS metastases for whom radiotherapy is not an option will be allowed to participate in this study
* Measurable disease by RECIST Version 1.1 prior to the administration of study treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* For all females of childbearing potential, a negative pregnancy test must be obtained within 3 days before starting study treatment

Exclusion Criteria

* Participants with a previous malignancy within the past 3 years are excluded (other than curatively treated basal cell carcinoma of the skin, early gastrointestinal \[GI\] cancer by endoscopic resection or in situ carcinoma of the cervix)
* Participants who have received any previous ALK inhibitor other than crizotinib
* Any GI disorder that may affect absorption of oral medications
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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GHdC Site Notre Dame

Charleroi, , Belgium

Site Status

UZ Antwerpen

Edegem, , Belgium

Site Status

UZ Gent

Ghent, , Belgium

Site Status

MBAL Serdika EOOD

Sofia, , Bulgaria

Site Status

Centre Francois Baclesse

Caen, , France

Site Status

Hopital Bichat Claude Bernard ; Service de Pneumologie

Paris, , France

Site Status

Hopital Du Haut Leveque; Service Des Maladies Respiratoires

Pessac, , France

Site Status

Hopital Foch; Pneumologie

Suresnes, , France

Site Status

Hopital Sainte Musse; Pneumologie

Toulon, , France

Site Status

Hopital Larrey; Pneumologie

Toulouse, , France

Site Status

Hopital Robert Schuman; Pneumologie

Vantoux, , France

Site Status

Zentralklinik Bad Berka GmbH; Abteilung Onkologie und Hämatologie

Bad Berka, , Germany

Site Status

Evang. Lungenklinik Berlin Klinik für Pneumologie

Berlin, , Germany

Site Status

Asklepios-Fachkliniken Muenchen-Gauting; Onkologie

Gauting, , Germany

Site Status

Fachklinik für Lungenerkrankungen

Immenhausen, , Germany

Site Status

Pius-Hospital; Klinik fuer Haematologie und Onkologie

Oldenburg, , Germany

Site Status

Queen Elizabeth Hospital; Clinical Oncology

Hong Kong, , Hong Kong

Site Status

Queen Mary Hospital; Dept. of Clinical Oncology

Hong Kong, , Hong Kong

Site Status

Semmelweis Egyetem X; Pulmonologiai Klinika

Budapest, , Hungary

Site Status

Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati

Avellino, Campania, Italy

Site Status

AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico

Napoli, Campania, Italy

Site Status

Istituto Nazionale Tumori Fondazione G. Pascale; U.O.C. Oncologia Medica Toraco Polmonare

Napoli, Campania, Italy

Site Status

Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica

Ravenna, Emilia-Romagna, Italy

Site Status

Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1

Rome, Lazio, Italy

Site Status

Irccs Ospedale San Raffaele;Oncologia Medica

Milan, Lombardy, Italy

Site Status

Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

Milan, Lombardy, Italy

Site Status

POLICLINICO RODOLICO, U.O. di Oncologia Medica

Catania, Sicily, Italy

Site Status

A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii

Pisa, Tuscany, Italy

Site Status

Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

Perugia, Umbria, Italy

Site Status

Oslo Universitetssykehus HF; Radiumhospitalet

Oslo, , Norway

Site Status

Medical University of Gdansk

Gdansk, , Poland

Site Status

Hospital Geral; Servico de Pneumologia

Coimbra, , Portugal

Site Status

IPO do Porto; Servico de Oncologia Medica

Porto, , Portugal

Site Status

CHVNG/E_Unidade 1; Servico de Pneumologia

Vila Nova de Gaia, , Portugal

Site Status

University сlinic of headaches

Moscow, Moscow Oblast, Russia

Site Status

FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

Main Military Clinical Hospital named after N.N. Burdenko

Moscow, , Russia

Site Status

City Clinical Oncology Hospital

Moscow, , Russia

Site Status

City Clinical Oncology Dispensary

Saint Petersburg, , Russia

Site Status

S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

Saint Petersburg, , Russia

Site Status

FNsP F. D. Roosevelta Banska Bystrica, II.Ocna klinika SZU

Banská Bystrica, , Slovakia

Site Status

Vychodoslovensky onkologicky ustav

Košice, , Slovakia

Site Status

Chonnam National University Hwasun Hospital

Jeollanam-do, , South Korea

Site Status

Korea University Guro Hospital; Oncology

Seoul, , South Korea

Site Status

Hospital Universitario de Torrejon

Torrejón de Ardoz, Madrid, Spain

Site Status

Hospital de Cruces; Servicio de Oncologia

Bilbao, Vizcaya, Spain

Site Status

Hospital Universitario La Paz; Servicio de Oncologia

Madrid, , Spain

Site Status

Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

Málaga, , Spain

Site Status

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, , Spain

Site Status

Adana Acıbadem Hospital Oncology Department

Adana, , Turkey (Türkiye)

Site Status

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Ankara, , Turkey (Türkiye)

Site Status

Istanbul Uni Capa Medical Faculty; Inst. of Oncology

Istanbul, , Turkey (Türkiye)

Site Status

Ege University Medical Faculty; Chest Diseases

Izmir, , Turkey (Türkiye)

Site Status

Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

Malatya, , Turkey (Türkiye)

Site Status

Countries

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Belgium Bulgaria France Germany Hong Kong Hungary Italy Norway Poland Portugal Russia Slovakia South Korea Spain Turkey (Türkiye)

References

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Sikkema BJ, Baart SJ, Paats MS, Smit EF, Schols AMWJ, Mathijssen RHJ, van Rossum EFC, Dingemans AC. Body Weight Gain Associated With Alectinib in Patients With ALK+ Non-Small Cell Lung Cancer: Pooled Analysis of Individual Patient Data From Four Prospective Clinical Trials. J Clin Oncol. 2025 Feb 20;43(6):641-650. doi: 10.1200/JCO-24-01579. Epub 2024 Dec 11.

Reference Type DERIVED
PMID: 39661917 (View on PubMed)

Novello S, Mazieres J, Oh IJ, de Castro J, Migliorino MR, Helland A, Dziadziuszko R, Griesinger F, Kotb A, Zeaiter A, Cardona A, Balas B, Johannsdottir HK, Das-Gupta A, Wolf J. Alectinib versus chemotherapy in crizotinib-pretreated anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer: results from the phase III ALUR study. Ann Oncol. 2018 Jun 1;29(6):1409-1416. doi: 10.1093/annonc/mdy121.

Reference Type DERIVED
PMID: 29668860 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2015-000634-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MO29750

Identifier Type: -

Identifier Source: org_study_id

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