Clinical trial • Phase III • Oncology
ALECTINIB for ALK-positive non-small cell lung cancer | Resected stage Ib–IIIa non-small cell lung cancer
Phase III trial of ALECTINIB for ALK-positive non-small cell lung cancer | Resected stage Ib–IIIa non-small cell lung cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- ALK-positive non-small cell lung cancer | Resected stage Ib–IIIa non-small cell lung cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 19-04-2024
- First CTIS Authorization Date
- 21-05-2024
Trial design
Randomised, open-label, experimental arm: alectinib 600 mg orally twice daily (bid) with food for 24 months. control arm 1: cisplatin 75 mg/m2 on day 1 plus vinorelbine 25 mg/m2 on days 1 and 8. control arm 2: cisplatin 75 mg/m2 on day 1 plus gemcitabine 1250 mg/m2 on days 1 and 8. control arm 3: cisplatin 75 mg/m2 on day 1 plus pemetrexed 500 mg/m2 on day 1. Phase III trial in Romania, Denmark, Spain and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Experimental arm: Alectinib 600 mg orally twice daily (BID) with food for 24 months. Control arm 1: Cisplatin 75 mg/m2 on Day 1 plus vinorelbine 25 mg/m2 on Days 1 and 8. Control arm 2: Cisplatin 75 mg/m2 on Day 1 plus gemcitabine 1250 mg/m2 on Days 1 and 8. Control arm 3: Cisplatin 75 mg/m2 on Day 1 plus pemetrexed 500 mg/m2 on Day 1.
- Target Sample Size
- 202
- Trial Duration For Participant
- 730
Eligibility
Recruits 202 Vulnerable population flag selected in the trial record (populationOfTrialSubjects.isVulnerablePopulationSelected = true). Informed consent is to be obtained using the Subject Information and Informed Consent Forms (multiple ICF documents and language versions are provided). No explicit assent or age-specific parental consent procedures are detailed in the available CTIS data..
- Pregnancy Exclusion
- Pregnant or breastfeeding, or intending to become pregnant during the study and for at least 5 weeks after the last dose of alectinib or according to local labels or guidelines for chemotherapy
- Vulnerable Population
- Vulnerable population flag selected in the trial record (populationOfTrialSubjects.isVulnerablePopulationSelected = true). Informed consent is to be obtained using the Subject Information and Informed Consent Forms (multiple ICF documents and language versions are provided). No explicit assent or age-specific parental consent procedures are detailed in the available CTIS data.
Inclusion criteria
- {"criterion_text":"- Complete resection of histologically-confirmed Stage Ib (tumor ≥ 4 cm) to Stage IIIa (T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) NSCLC as per UICC/AJCC, 7th edition, with negative margins, at 4-12 weeks before enrollment"}
- {"criterion_text":"- Documented ALK-positive disease according to an FDA-approved and CE-marked test"}
- {"criterion_text":"- Eligible to receive a platinum-based chemotherapy regimen according to the local labels or guidelines"}
- {"criterion_text":"- Eastern Cooperative Oncology Group Performance Status of Grade 0 or 1"}
- {"criterion_text":"- Adequate hematologic and renal function"}
- {"criterion_text":"- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures"}
Exclusion criteria
- {"criterion_text":"- Pregnant or breastfeeding, or intending to become pregnant during the study and for at least 5 weeks after the last dose of alectinib or according to local labels or guidelines for chemotherapy"}
- {"criterion_text":"- Prior adjuvant radiotherapy for NSCLC Prior exposure to systemic anti-cancer therapy and ALK inhibitors"}
- {"criterion_text":"- Stage IIIA N2 patients that, in the investigator's opinion, should receive post-operative radiotherapy treatment are excluded from the study"}
- {"criterion_text":"- Known sensitivity to any component of study drug to which the patient may be randomized. This includes, but is not limited to, patients with galactose intolerance, a congenital lactase deficiency or glucose-galactose malabsorption."}
- {"criterion_text":"- Significant liver disease or impaired liver transaminase enzymes levels, symptomatic bradycardia, any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post-major bowel resection, HIV positivity"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Disease-free survival per investigator’s assessment","definition_or_measurement_approach":"Disease-free survival assessed by the investigator (investigator-assessed DFS as stated in the main objective/endpoints)."}
Secondary endpoints
- {"endpoint_text":"- 1. Overall survival","definition_or_measurement_approach":"Overall survival (time from randomisation to death from any cause)."}
- {"endpoint_text":"- 2. Incidence of adverse events, with severity determined through use of National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0","definition_or_measurement_approach":"Incidence and severity of adverse events graded using NCI CTCAE v5.0."}
- {"endpoint_text":"- 3. Incidence of abnormal laboratory findings","definition_or_measurement_approach":"Incidence of clinically relevant abnormal laboratory results (laboratory assessments per protocol)."}
- {"endpoint_text":"- 4. Changes in vital signs and electrocardiograms","definition_or_measurement_approach":"Changes in vital signs and ECG parameters measured at protocol-specified timepoints."}
- {"endpoint_text":"- 5. Plasma concentrations of alectinib and its major metabolite(s) at specified timepoints for alectinib","definition_or_measurement_approach":"Plasma pharmacokinetic sampling for alectinib and major metabolites at specified timepoints (PK characterization)."}
Recruitment
- Planned Sample Size
- 202
- Recruitment Window Months
- 95
- Consent Approach
- Informed consent obtained via subject information sheets and informed consent forms (multiple ICF documents present in the dossier). Multiple language versions and addenda exist (examples: EN, DE, FR, ES, IT, PL, GR, HU, RO). No explicit description of assent or separate parental consent for minors is provided in the available CTIS data.
Geography
- Total Number Of Sites
- 31
- Total Number Of Participants
- 55
Romania
- Earliest CTIS Part Ii Submission Date
- 06-05-2024
- Latest Decision Or Authorization Date
- 06-04-2026
- Processing Time Days
- 700
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Oncology
- Principal Investigator Name
- Tudor Ciuleanu
- Principal Investigator Email
- office@iocn.ro
- Contact Person Name
- Tudor Ciuleanu
- Contact Person Email
- office@iocn.ro
- Site Name
- Oncomed S.R.L.
- Department Name
- Oncology
- Principal Investigator Name
- Dorel Popovici
- Principal Investigator Email
- office@oncohelp.ro
- Contact Person Name
- Dorel Popovici
- Contact Person Email
- office@oncohelp.ro
Denmark
- Earliest CTIS Part Ii Submission Date
- 06-05-2024
- Latest Decision Or Authorization Date
- 20-02-2026
- Processing Time Days
- 655
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Odense University Hospital
- Department Name
- Onkologisk afdeling R
- Principal Investigator Name
- Lise Eckhoff
- Principal Investigator Email
- ouh.ode.r.ctis@rsyd.dk
- Contact Person Name
- Lise Eckhoff
- Contact Person Email
- ouh.ode.r.ctis@rsyd.dk
Spain
- Earliest CTIS Part Ii Submission Date
- 06-05-2024
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 667
- Number Of Sites
- 7
- Number Of Participants
- 7
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncología
- Principal Investigator Name
- Aleix Martí
- Principal Investigator Email
- amartinezmarti@vhio.net
- Contact Person Name
- Aleix Martí
- Contact Person Email
- amartinezmarti@vhio.net
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Oncología
- Principal Investigator Name
- Enric Carcereny
- Principal Investigator Email
- ecarcereny@iconcologia.net
- Contact Person Name
- Enric Carcereny
- Contact Person Email
- ecarcereny@iconcologia.net
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncología
- Principal Investigator Name
- Reyes Bernabe
- Principal Investigator Email
- reyesbernab@yahoo.es
- Contact Person Name
- Reyes Bernabe
- Contact Person Email
- reyesbernab@yahoo.es
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Oncología
- Principal Investigator Name
- Amelia Insa
- Principal Investigator Email
- ameliainsamolla@gmail.com
- Contact Person Name
- Amelia Insa
- Contact Person Email
- ameliainsamolla@gmail.com
- Site Name
- Hospital Universitario La Paz
- Department Name
- Oncología
- Principal Investigator Name
- Javier De Castro
- Principal Investigator Email
- javier.decastro@salud.madrid.org
- Contact Person Name
- Javier De Castro
- Contact Person Email
- javier.decastro@salud.madrid.org
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Oncología
- Principal Investigator Name
- Margarita Magem
- Principal Investigator Email
- mmajem@santpau.cat
- Contact Person Name
- Margarita Magem
- Contact Person Email
- mmajem@santpau.cat
- Site Name
- Hospital Universitari Vall D Hebron (duplicate entry in CTIS list)
- Department Name
- Oncología
- Principal Investigator Name
- Aleix Martí
- Principal Investigator Email
- amartinezmarti@vhio.net
- Contact Person Name
- Aleix Martí
- Contact Person Email
- amartinezmarti@vhio.net
Austria
- Earliest CTIS Part Ii Submission Date
- 06-05-2024
- Latest Decision Or Authorization Date
- 26-02-2026
- Processing Time Days
- 661
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Krankenhaus Nord Klinik Floridsdorf
- Department Name
- Department for Respiratory and Critical Care Medicine
- Principal Investigator Name
- Maximilian Hochmair
- Principal Investigator Email
- maximilian.hochmair@gesundheitsverbund.at
- Contact Person Name
- Maximilian Hochmair
- Contact Person Email
- maximilian.hochmair@gesundheitsverbund.at
Hungary
- Earliest CTIS Part Ii Submission Date
- 06-05-2024
- Latest Decision Or Authorization Date
- 25-02-2026
- Processing Time Days
- 660
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Orszagos Onkologiai Intezet
- Department Name
- Belgyógyászati-Onkológiai Osztály és Klinikai Farmakológiai Osztály
- Principal Investigator Name
- Tünde Nagy
- Principal Investigator Email
- drnt@freemail.hu
- Contact Person Name
- Tünde Nagy
- Contact Person Email
- drnt@freemail.hu
- Site Name
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
- Department Name
- Onkológiai központ
- Principal Investigator Name
- Hajnalka Nemeth
- Principal Investigator Email
- nemethhajnalka@hotmail.com
- Contact Person Name
- Hajnalka Nemeth
- Contact Person Email
- nemethhajnalka@hotmail.com
France
- Earliest CTIS Part Ii Submission Date
- 06-05-2024
- Latest Decision Or Authorization Date
- 25-02-2026
- Processing Time Days
- 660
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Service d'Oncologie Thoracique
- Principal Investigator Name
- David PLANCHARD
- Principal Investigator Email
- david.planchard@gustaveroussy.fr
- Contact Person Name
- David PLANCHARD
- Contact Person Email
- david.planchard@gustaveroussy.fr
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- Service de Pneumologie
- Principal Investigator Name
- José HUREAUX
- Principal Investigator Email
- jose.hureaux@chu-angers.fr
- Contact Person Name
- José HUREAUX
- Contact Person Email
- jose.hureaux@chu-angers.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Oncologie Multidisciplinaire et Innovations thérapeutiques
- Principal Investigator Name
- Pascale TOMASINI
- Principal Investigator Email
- pascale.tomasini@ap-hm.fr
- Contact Person Name
- Pascale TOMASINI
- Contact Person Email
- pascale.tomasini@ap-hm.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 06-05-2024
- Latest Decision Or Authorization Date
- 10-03-2026
- Processing Time Days
- 673
- Number Of Sites
- 4
- Number Of Participants
- 6
Sites
- Site Name
- Thoraxklinik Heidelberg gGmbH
- Department Name
- Thoraxklinik
- Principal Investigator Name
- Helge Bischoff
- Principal Investigator Email
- helge.bischoff@med.uni-heidelberg.de
- Contact Person Name
- Helge Bischoff
- Contact Person Email
- helge.bischoff@med.uni-heidelberg.de
- Site Name
- Klinikum Chemnitz gGmbH
- Department Name
- Innere Medizin IV
- Principal Investigator Name
- Stefan Hammerschmidt
- Principal Investigator Email
- S.Hammerschmidt@skc.de
- Contact Person Name
- Stefan Hammerschmidt
- Contact Person Email
- S.Hammerschmidt@skc.de
- Site Name
- Franziskus Hospital Harderberg
- Department Name
- Klinik für Thoraxonkologie
- Principal Investigator Name
- Petra Hoffknecht
- Principal Investigator Email
- petra.hoffknecht@niels-stensen-kliniken.de
- Contact Person Name
- Petra Hoffknecht
- Contact Person Email
- petra.hoffknecht@niels-stensen-kliniken.de
- Site Name
- Lungenfachklinik Immenhausen
- Principal Investigator Name
- Achim Rittmeyer
- Principal Investigator Email
- k.schwedler@lungenfachklinik-immenhausen.de
- Contact Person Name
- Achim Rittmeyer
- Contact Person Email
- k.schwedler@lungenfachklinik-immenhausen.de
Poland
- Earliest CTIS Part Ii Submission Date
- 06-05-2024
- Latest Decision Or Authorization Date
- 26-02-2026
- Processing Time Days
- 662
- Number Of Sites
- 4
- Number Of Participants
- 8
Sites
- Site Name
- Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
- Department Name
- Oddział onkologii z pododdziałem chemioterapii
- Principal Investigator Name
- Andrzej Każarnowicz
- Principal Investigator Email
- sekretariat@pulmonologia.olsztyn.pl
- Contact Person Name
- Andrzej Każarnowicz
- Contact Person Email
- sekretariat@pulmonologia.olsztyn.pl
- Site Name
- Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
- Department Name
- Oddział Onkologii Klinicznej z Pododdziałem Dziennej Chemioterapii
- Principal Investigator Name
- Katarzyna Stencel
- Principal Investigator Email
- poznan@wcpit.org
- Contact Person Name
- Katarzyna Stencel
- Contact Person Email
- poznan@wcpit.org
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Onkologii i Radioterapii
- Principal Investigator Name
- Rafał Dziadziuszko
- Principal Investigator Email
- onkologia@uck.gda.pl
- Contact Person Name
- Rafał Dziadziuszko
- Contact Person Email
- onkologia@uck.gda.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworów Płuca i Klatki Piersiowej
- Principal Investigator Name
- Maciej Głogowski
- Principal Investigator Email
- malgorzata.falgowska@nio.gov.pl
- Contact Person Name
- Maciej Głogowski
- Contact Person Email
- malgorzata.falgowska@nio.gov.pl
Italy
- Earliest CTIS Part Ii Submission Date
- 06-05-2024
- Latest Decision Or Authorization Date
- 23-02-2026
- Processing Time Days
- 658
- Number Of Sites
- 5
- Number Of Participants
- 15
Sites
- Site Name
- Azienda Ospedaliera Dei Colli
- Department Name
- Pneumologia Oncologica
- Principal Investigator Name
- Fabiana Vitiello
- Principal Investigator Email
- fabianavitiello@libero.it
- Contact Person Name
- Fabiana Vitiello
- Contact Person Email
- fabianavitiello@libero.it
- Site Name
- Hospital Santa Maria Della Misericordia
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Giulio Metro
- Principal Investigator Email
- giulio.metro@ospedale.perugia.it
- Contact Person Name
- Giulio Metro
- Contact Person Email
- giulio.metro@ospedale.perugia.it
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- Malattie Apparato Respiratorio 5 ad Indirizzo Oncologico
- Principal Investigator Name
- Silvia Novello
- Principal Investigator Email
- silvia.novello@unito.it
- Contact Person Name
- Silvia Novello
- Contact Person Email
- silvia.novello@unito.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Divisione di Oncologia
- Principal Investigator Name
- Gianluca Spitaleri
- Principal Investigator Email
- gianluca.spitaleri@ieo.it
- Contact Person Name
- Gianluca Spitaleri
- Contact Person Email
- gianluca.spitaleri@ieo.it
- Site Name
- San Camillo Forlanini Hospital
- Department Name
- Unità Operativa Complessa di Pneumologia Oncologica 1
- Principal Investigator Name
- Serena Ricciardi
- Principal Investigator Email
- sricciardi@scamilloforlanini.rm.it
- Contact Person Name
- Serena Ricciardi
- Contact Person Email
- sricciardi@scamilloforlanini.rm.it
Greece
- Earliest CTIS Part Ii Submission Date
- 04-07-2024
- Latest Decision Or Authorization Date
- 24-02-2026
- Processing Time Days
- 600
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Metropolitan Hospital
- Department Name
- Β΄ Oncology Department
- Principal Investigator Name
- Epaminondas Samantas
- Principal Investigator Email
- epsam@otenet.gr
- Contact Person Name
- Epaminondas Samantas
- Contact Person Email
- epsam@otenet.gr
- Site Name
- Theageneio Cancer Hospital
- Department Name
- Oncology Clinic
- Principal Investigator Name
- Theodora Tsiouda
- Principal Investigator Email
- doratsiouda@yahoo.gr
- Contact Person Name
- Theodora Tsiouda
- Contact Person Email
- doratsiouda@yahoo.gr
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Almac Clinical Technologies LLC
- Responsibilities
- Randomization
- Name
- Bioclinica Inc.
- Responsibilities
- Other Third Party Duty
- Name
- Greenphire LLC
- Responsibilities
- Other Third Party Duty
- Name
- Fortrea Inc.
- Responsibilities
- Other Third Party Duty
- Name
- Labcorp Central Laboratory Services SARL
- Responsibilities
- code:4
- Name
- CellCarta
- Responsibilities
- code:4
- Name
- Foundation Medicine Inc.
- Responsibilities
- Other Third Party Duty
Third parties
- {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"Other Third Party Duty","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Axon Communications Inc.","duties_or_roles":"Meeting Organizer","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Other Third Party Duty","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Other Third Party Duty","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Other Third Party Duty","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"Randomization","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- Alecensa 150 mg hard capsules
- Active Substance
- ALECTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- Authorised
- Starting Dose
- 600 mg orally twice daily (BID) with food (per protocol experimental arm)
- Dose Levels
- 600 mg BID (fixed)
- Frequency
- Twice daily (BID)
- Maximum Dose
- 1200 mg/day
- Investigational Product Name
- VINORELBINE
- Active Substance
- VINORELBINE
- Modality
- Small molecule
- Routes Of Administration
- IV INFUSION
- Route
- IV infusion
- Authorisation Status
- Authorised
- Starting Dose
- 25 mg/m2 on Days 1 and 8 (when used with cisplatin)
- Dose Levels
- 25 mg/m2
- Frequency
- Days 1 and 8 of cycle
- Maximum Dose
- 25 mg/m2 (per dosing information provided)
- Investigational Product Name
- Gemcitabin-GRY 1000 mg Pulver zur Herstellung einer Infusionslösung
- Active Substance
- GEMCITABINE HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- IV INFUSION
- Route
- IV infusion
- Authorisation Status
- Authorised
- Starting Dose
- 1250 mg/m2 on Days 1 and 8 (when used with cisplatin)
- Dose Levels
- 1250 mg/m2
- Frequency
- Days 1 and 8 of cycle
- Maximum Dose
- 1250 mg/m2
- Investigational Product Name
- Cisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung
- Active Substance
- CISPLATIN
- Modality
- Small molecule
- Routes Of Administration
- IV INFUSION
- Route
- IV infusion
- Authorisation Status
- Authorised
- Starting Dose
- 75 mg/m2 on Day 1 (used in control arms)
- Dose Levels
- 75 mg/m2
- Frequency
- Day 1 of cycle
- Maximum Dose
- 75 mg/m2
- Investigational Product Name
- Carboplatin ACTAVIS 10 mg/ml concentrat pentru soluţie perfuzabilă / Carboplatin-GRY® 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
- Active Substance
- CARBOPLATIN
- Modality
- Small molecule
- Routes Of Administration
- IV INFUSION
- Route
- IV infusion
- Authorisation Status
- Authorised
- Investigational Product Name
- ALIMTA 500 mg powder for concentrate for solution for infusion
- Active Substance
- PEMETREXED
- Modality
- Small molecule
- Routes Of Administration
- IV INFUSION
- Route
- IV infusion
- Authorisation Status
- Authorised
- Starting Dose
- 500 mg/m2 on Day 1 (when used with cisplatin according to one control arm)
- Dose Levels
- 500 mg/m2
- Frequency
- Day 1 of cycle
- Maximum Dose
- 500 mg/m2
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