Clinical trial • Phase I|Phase II|Phase III • Oncology

ALECTINIB for Non-small cell lung cancer (locally advanced, unresectable, Stage III)

Phase I|Phase II|Phase III trial of ALECTINIB for Non-small cell lung cancer (locally advanced, unresectable, Stage III).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer (locally advanced, unresectable, Stage III)
Trial Stage
Phase I|Phase II|Phase III
Drug Modality
Small molecule | Monoclonal antibody

Key dates

Initial CTIS Submission Date
10-01-2024
First CTIS Authorization Date
13-02-2024

Trial design

Randomised, durvalumab (imfinzi 50 mg/ml concentrate for solution for infusion) - dosing/schedule not specified-controlled Phase I|Phase II|Phase III trial in Spain, Norway, Germany and others.

Randomised
Yes
Comparator
Durvalumab (IMFINZI 50 mg/mL concentrate for solution for infusion) - dosing/schedule not specified
Biomarker Stratified
True, ALK fusion (Cohort A1) and ROS1 fusion (Cohort A2)
Target Sample Size
293

Eligibility

Recruits 293 Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms include specific documents referencing pregnant partners, infant/newborn (e.g. "Infant Authorization", "Enfant ne", "Pregnant Partner" documents) and infant authorization/privacy forms. An "Informed Consent Form Procedure" document is listed. This indicates special consent/authorization documents exist for infants/newborns and pregnant partners and that procedures for obtaining consent are provided..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms include specific documents referencing pregnant partners, infant/newborn (e.g. "Infant Authorization", "Enfant ne", "Pregnant Partner" documents) and infant authorization/privacy forms. An "Informed Consent Form Procedure" document is listed. This indicates special consent/authorization documents exist for infants/newborns and pregnant partners and that procedures for obtaining consent are provided.

Inclusion criteria

  • {"criterion_text":"- Whole-body positron emission tomography/computed tomography scan (PET-CT) performed prior and within 42 for Cohort A2 (ROS1 positive) and 50 days for Cohort A1 (ALK positive) days of the first dose of cCRT or sCRT\n- Histologically or cytologically documented locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology (Version 8, American Joint Committee on Cancer/Union for International Cancer Control NSCLC staging system)\n- No disease progression during or following receipt of at least 2 cycles of platinum-based cCRT or sCRT\n- Documented ALK fusion positivity (Cohort A1)\n- Documented ROS1 fusion positivity (Cohort A2)\n- Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2"}

Exclusion criteria

  • {"criterion_text":"- Any history of previous NSCLC and/or any history of prior treatment for NSCLC\n- Any evidence of Stage IV disease\n- NSCLC known to have a known or likely oncogenic-driver mutation in the EGFR gene, as identified by site local testing or Sponsor central testing\n- Prior treatment with ALK inhibitors (Cohort A1)\n- Prior treatment with ROS1 inhibitors (Cohort A2)\n- Active or history of autoimmune disease or immune deficiency"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1. Progression-free survival (PFS), as determined by Blinded independent central review (BICR) per RECIST v1.1","definition_or_measurement_approach":"Determined by Blinded Independent Central Review (BICR) per RECIST v1.1"}

Secondary endpoints

  • {"endpoint_text":"- 1. PFS, defined as the time from randomization to the first documented disease progression, as determined by the investigator per RECIST v1.1, or death from any cause, whichever occurs first","definition_or_measurement_approach":"Time from randomization to first documented disease progression (investigator assessment) per RECIST v1.1, or death"}
  • {"endpoint_text":"- 2. Time to central nervous system (CNS) progression, as determined by BICR and investigator per RECIST v1.1","definition_or_measurement_approach":"Time to CNS progression assessed by BICR and investigator per RECIST v1.1"}
  • {"endpoint_text":"- 3. Distant metastasis-free survival (DMFS), as determined by BICR and investigator per RECIST v1.1","definition_or_measurement_approach":"DMFS assessed by BICR and investigator per RECIST v1.1"}
  • {"endpoint_text":"- 4. Objective response rate (ORR), as determined by BICR and investigator per RECIST v1.1","definition_or_measurement_approach":"ORR determined by BICR and investigator per RECIST v1.1"}
  • {"endpoint_text":"- 5. Duration of response (DOR), as determined by BICR and investigator per RECIST v1.1","definition_or_measurement_approach":"DOR determined by BICR and investigator per RECIST v1.1"}
  • {"endpoint_text":"- 6. Overall survival (OS)","definition_or_measurement_approach":"Overall survival (time to death from any cause)"}
  • {"endpoint_text":"- 7. Time-to-confirmed deterioration (TTCD), in the following patient-reported scales and lung cancer symptoms: Physical functioning, Role functioning, Cough, Chest pain, Dyspnea","definition_or_measurement_approach":"TTCD measured using patient-reported scales for physical functioning, role functioning and symptoms (cough, chest pain, dyspnea)"}
  • {"endpoint_text":"- 8. Change from baseline score as measured through the use of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) at 5, 11, and 17 months in the following patient-reported scales and lung cancer symptoms: Physical functioning, Role functioning, Cough, Chest pain, Dyspnea","definition_or_measurement_approach":"Change from baseline on EORTC QLQ-C30 at months 5, 11 and 17 in listed scales/symptoms"}
  • {"endpoint_text":"- 9. Incidence, type, and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)","definition_or_measurement_approach":"Adverse events graded and reported per NCI CTCAE v5.0"}
  • {"endpoint_text":"- 10. Changes in vital signs, physical findings, and clinical laboratory results during and following administration of protocol-specified investigational medicinal products (IMPs)","definition_or_measurement_approach":"Changes in vital signs, physical findings, and laboratory results during and after IMP administration as per protocol assessments"}

Recruitment

Planned Sample Size
293
Recruitment Window Months
115
Consent Approach
Informed consent obtained via subject information and informed consent forms (multiple ICF documents listed). Country- and language-specific ICFs and patient-facing materials are provided (documents in English, Spanish, French, Dutch, German, Italian, Swedish and others). Specific consent/authorization documents exist for pregnant partners and for infants/newborns (e.g. 'Pregnant Partner', 'Infant Authorization', 'Infant Authorization Form', 'Enfant ne'), and an 'Informed Consent Form Procedure' document is listed describing the consent process.

Methods

  • Site-based recruitment at participating hospitals/clinics (multiple hospital sites listed per country)
  • Recruitment support/activities provided by third-party recruitment vendor (Massive Bio Inc. listed with duty 'Recruitment')
  • Referral materials and local recruitment materials including referral letters, referral fact cards, study flyers and patient information brochures (documents titled Study Flyer, Referral Letter, Referral Fact Card, Patient Information Brochure listed)
  • Biomarker prescreening (PET-CT prescreening and biomarker status leaflets/documents listed) and central/specialty laboratory testing (Foundation Medicine, Labcorp and other specialty laboratories listed)

Geography

Total Number Of Sites
46
Total Number Of Participants
39

Spain

Latest Decision Or Authorization Date
08-08-2025
Number Of Sites
14
Number Of Participants
7

Sites

Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncología
Principal Investigator Name
Pilar Garrido
Principal Investigator Email
pilargarridol@gmail.com
Contact Person Name
Pilar Garrido
Contact Person Email
pilargarridol@gmail.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncología
Principal Investigator Name
Amelia Insa Molla
Principal Investigator Email
ameliainsamolla@gmail.com
Contact Person Name
Amelia Insa Molla
Contact Person Email
ameliainsamolla@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncología
Principal Investigator Name
Luis Paz-Arez
Principal Investigator Email
lpazaresr@seom.org
Contact Person Name
Luis Paz-Arez
Contact Person Email
lpazaresr@seom.org
Site Name
Institut Catala D'oncologia
Department Name
Oncología
Principal Investigator Name
Ernest Nadal
Principal Investigator Email
esnadal@iconcologia.net
Contact Person Name
Ernest Nadal
Contact Person Email
esnadal@iconcologia.net
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
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncología
Principal Investigator Name
Patricia Iranzo
Principal Investigator Email
piranzo@vhio.net
Contact Person Name
Patricia Iranzo
Contact Person Email
piranzo@vhio.net
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncología
Principal Investigator Name
Maria Rosario Garcia Campelo
Principal Investigator Email
ma.rosario.garcia.campelo@sergas.es
Contact Person Name
Maria Rosario Garcia Campelo
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Oncología
Principal Investigator Name
Bartomeu Massuti Sureda
Principal Investigator Email
bmassutis@seom.org
Contact Person Name
Bartomeu Massuti Sureda
Contact Person Email
bmassutis@seom.org
Site Name
Parc Tauli Hospital Universitari
Department Name
Oncología
Principal Investigator Name
Laia Vila
Principal Investigator Email
lvila@tauli.cat
Contact Person Name
Laia Vila
Contact Person Email
lvila@tauli.cat
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncología
Principal Investigator Name
Jose Miguel Jurado
Principal Investigator Email
jmjurado88@gmail.com
Contact Person Name
Jose Miguel Jurado
Contact Person Email
jmjurado88@gmail.com
Site Name
University Hospital Son Espases
Department Name
Oncología
Principal Investigator Name
Aitor Azkarate
Principal Investigator Email
aitor.azkarate@ssib.es
Contact Person Name
Aitor Azkarate
Contact Person Email
aitor.azkarate@ssib.es
Site Name
Hospital Universitario Central De Asturias
Department Name
Oncología
Principal Investigator Name
Noemi Villanueva
Principal Investigator Email
noemivipa@gmail.com
Contact Person Name
Noemi Villanueva
Contact Person Email
noemivipa@gmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncología
Principal Investigator Name
Reyes Bernabé
Principal Investigator Email
reyesbernab@yahoo.es
Contact Person Name
Reyes Bernabé
Contact Person Email
reyesbernab@yahoo.es
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
Oncología
Principal Investigator Name
Delvys Rodriguez
Principal Investigator Email
delvysra@yahoo.com
Contact Person Name
Delvys Rodriguez
Contact Person Email
delvysra@yahoo.com

Norway

Latest Decision Or Authorization Date
05-08-2025
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Oslo University Hospital HF
Department Name
Kreftsenteret, Radiumhospitalet
Principal Investigator Name
Maria Bjaanaes
Principal Investigator Email
mamok@ous-hf.no
Contact Person Name
Maria Bjaanaes
Contact Person Email
mamok@ous-hf.no

Germany

Latest Decision Or Authorization Date
05-08-2025
Number Of Sites
7
Number Of Participants
5

Sites

Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Medizinische Klinik und Poliklinik II Interdisziplinäres Studienzentrum mit ECTU
Principal Investigator Name
Pius Jung
Principal Investigator Email
isz_koordination@ukw.de
Contact Person Name
Pius Jung
Contact Person Email
isz_koordination@ukw.de
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik und Poliklinik für innere Medizin II, Pneumologie
Principal Investigator Name
Christian Schulz
Principal Investigator Email
christian.schulz@ukr.de
Contact Person Name
Christian Schulz
Contact Person Email
christian.schulz@ukr.de
Site Name
Klinikum Esslingen GmbH
Department Name
KLINIK FÜR Kardiologie, Angiologie und Pneumologie
Principal Investigator Name
Martin Faehling
Principal Investigator Email
m.faehling@klinikum-esslingen.de
Contact Person Name
Martin Faehling
Site Name
Ludwig Maximilian University Of Munich
Department Name
Medizinische Klinik und Poliklinik V, Campus Innenstadt
Principal Investigator Name
Amanda Tufman
Principal Investigator Email
pneumologie@med.uni-muenchen.de
Contact Person Name
Amanda Tufman
Site Name
Klinikum Chemnitz gGmbH
Department Name
Klinik Innere Med. IV - Pneumologie/Intensivmedizin/Onkologie/Allergologie/Schlaf- u. Beatmungsmed.
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
HELIOS Klinikum Emil von Behring GmbH
Department Name
Klinik für Pneumologie, Lungenklinik Heckeshorn
Principal Investigator Name
Jens Kollmeier
Principal Investigator Email
jens.kollmeier@helios-gesundheit.de
Contact Person Name
Jens Kollmeier
Site Name
Thoraxklinik Heidelberg gGmbH
Department Name
Thoraxonkologie
Principal Investigator Name
Farastuk Bozorgmehr
Principal Investigator Email
farastuk.bozorgmehr@med.uni-heidelberg.de
Contact Person Name
Farastuk Bozorgmehr

Poland

Latest Decision Or Authorization Date
11-08-2025
Number Of Sites
4
Number Of Participants
3

Sites

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
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Department Name
Oddział onkologii z pododdziałem chemioterapii
Principal Investigator Name
Jarosław Kołb-Sielecki
Principal Investigator Email
sekretariat@pulmonologia.olsztyn.pl
Contact Person Name
Jarosław Kołb-Sielecki
Site Name
Instytut Genetyki I Immunologii Genim Sp. z o.o.
Principal Investigator Name
Izabela Chmielewska
Principal Investigator Email
biuro@genim.pl
Contact Person Name
Izabela Chmielewska
Contact Person Email
biuro@genim.pl
Site Name
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Department Name
Oddział Onkologii Klinicznej
Principal Investigator Name
Krzysztof Rogoziewicz
Principal Investigator Email
chemia.dz@dco.com.pl
Contact Person Name
Krzysztof Rogoziewicz
Contact Person Email
chemia.dz@dco.com.pl

Netherlands

Latest Decision Or Authorization Date
05-08-2025
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
University Hospital Maastricht
Department Name
Lung Diseases
Principal Investigator Name
Lizza Hendriks
Principal Investigator Email
lizza.hendriks@mumc.nl
Contact Person Name
Lizza Hendriks
Contact Person Email
lizza.hendriks@mumc.nl

Italy

Latest Decision Or Authorization Date
13-02-2026
Number Of Sites
2
Number Of Participants
12

Sites

Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
Principal Investigator Name
Diego Signorelli
Principal Investigator Email
diego.signorelli@ospedaleniguarda.it
Contact Person Name
Diego Signorelli
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Principal Investigator Name
Angelo Delmonte
Principal Investigator Email
angelo.delmonte@irst.emr.it
Contact Person Name
Angelo Delmonte
Contact Person Email
angelo.delmonte@irst.emr.it

Sweden

Latest Decision Or Authorization Date
16-02-2026
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Karolinska University Hospital
Department Name
Tema Cancer, Huvud-, Hals-, Lung- och Hudcancer
Principal Investigator Name
Karam Al Jirf
Principal Investigator Email
karam.al-jirf@regionstockholm.se
Contact Person Name
Karam Al Jirf
Site Name
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Department Name
Oncology (Jubileumskliniken)
Principal Investigator Name
Kerstin Gunnarsson
Principal Investigator Email
kerstin.a.gunnarsson@vgregion.se
Contact Person Name
Kerstin Gunnarsson

Belgium

Latest Decision Or Authorization Date
16-02-2026
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Oncology (Pneumology)
Principal Investigator Name
Veerle Surmont
Principal Investigator Email
thoraxoncology@uzgent.be
Contact Person Name
Veerle Surmont
Contact Person Email
thoraxoncology@uzgent.be
Site Name
Grand Hopital De Charleroi
Department Name
Oncology & Hematology
Principal Investigator Name
Colinet Benoît
Principal Investigator Email
benoit.colinet2@ghdc.be
Contact Person Name
Colinet Benoît
Contact Person Email
benoit.colinet2@ghdc.be

France

Latest Decision Or Authorization Date
27-03-2026
Number Of Sites
13
Number Of Participants
3

Sites

Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Medical Oncology
Principal Investigator Name
Céline Mascaux
Principal Investigator Email
celine.mascaux@chru-strasbourg.fr
Contact Person Name
Céline Mascaux
Site Name
HIA Sainte Anne
Department Name
Pneumology
Principal Investigator Name
Olivier Bylicki
Principal Investigator Email
olivier.bylicki@intradef.gouv.fr
Contact Person Name
Olivier Bylicki
Site Name
Centre Francois Baclesse
Department Name
Medical Oncology
Principal Investigator Name
Hubert Curcio
Principal Investigator Email
h.curcio@baclesse.fr
Contact Person Name
Hubert Curcio
Contact Person Email
h.curcio@baclesse.fr
Site Name
Hopital Ambroise Pare
Department Name
Medical Oncology
Principal Investigator Name
Etienne Giroux-Leprieur
Principal Investigator Email
etienne.giroux-leprieur@aphp.fr
Contact Person Name
Etienne Giroux-Leprieur
Site Name
Centre Hospitalier Regional D'Angers
Department Name
Pneumology
Principal Investigator Name
Marie-Capucine Willemin
Principal Investigator Email
MarieCapucine.Willemin@chu-angers.fr
Contact Person Name
Marie-Capucine Willemin
Site Name
Unite De Recherche Clinique HIA Begin
Department Name
Pneumology
Principal Investigator Name
Hugo Picchi
Principal Investigator Email
picchi.hugo90@gmail.com
Contact Person Name
Hugo Picchi
Contact Person Email
picchi.hugo90@gmail.com
Site Name
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Department Name
Pneumology
Principal Investigator Name
Charles Naltet
Principal Investigator Email
cnaltet@ghpsj.fr
Contact Person Name
Charles Naltet
Contact Person Email
cnaltet@ghpsj.fr
Site Name
Assistance Publique Hopitaux De Marseille
Department Name
Medical Oncology
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
Site Name
Polyclinique Bordeaux Nord Aquitaine
Department Name
Medical Oncology
Principal Investigator Name
Sigolène Galland-Girodet
Principal Investigator Email
dr.sgalland@bordeauxnord.com
Contact Person Name
Sigolène Galland-Girodet
Contact Person Email
dr.sgalland@bordeauxnord.com
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Pneumology
Principal Investigator Name
Audrey Rabeau
Principal Investigator Email
rabeau.a@chu-toulouse.fr
Contact Person Name
Audrey Rabeau
Contact Person Email
rabeau.a@chu-toulouse.fr
Site Name
Centre Leon Berard
Department Name
Medical oncology
Principal Investigator Name
Aurélie Swalduz
Principal Investigator Email
Aurelie.SWALDUZ@lyon.unicancer.fr
Contact Person Name
Aurélie Swalduz
Site Name
Les Hopitaux / other listed French sites
Department Name
Various oncology/pneumology departments (multiple sites listed)
Site Name
Centre Francois Baclesse (duplicate listing consolidated)
Department Name
Medical Oncology
Principal Investigator Name
Hubert Curcio
Principal Investigator Email
h.curcio@baclesse.fr
Contact Person Name
Hubert Curcio
Contact Person Email
h.curcio@baclesse.fr

Sponsor

Primary sponsor

Full Name
F. Hoffmann-La Roche AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
Syneos Health Inc.
Responsibilities
Global CRO, Specialty Laboratory

Third parties

  • {"country":"France","full_name":"Median Technologies","duties_or_roles":"ECG Provider","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"Specialty Laboratory","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Kayentis","duties_or_roles":"Monitoring","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"Specialty Laboratory","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Specialty Laboratory","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Massive Bio Inc.","duties_or_roles":"Recruitment","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"Specialty Laboratory","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Global CRO, Specialty Laboratory","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"Specialty Laboratory","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 (marketing authorisation EU/1/16/1169/002)
Investigational Product Name
IMFINZI 50 mg/mL concentrate for solution for infusion.
Active Substance
DURVALUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Authorised (marketing authorisation EU/1/18/1322/001)

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