Clinical trial • Phase I/II | Phase III • Oncology
ALECTINIB for Non-small cell lung cancer | Resectable stage I-III non-small cell lung cancer
Phase I/II | Phase III trial of ALECTINIB for Non-small cell lung cancer | Resectable stage I-III non-small cell lung cancer. open-label. 96 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer | Resectable stage I-III non-small cell lung cancer
- Trial Stage
- Phase I/II | Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 25-10-2024
- First CTIS Authorization Date
- 03-03-2025
Trial design
open-label Phase I/II | Phase III trial in Austria, Belgium, Denmark and others.
- Open Label
- Yes
- Biomarker Stratified
- True, biomarker: ALK fusion (ALK-positive); cohorts stratified as Cohort B1 and Cohort B2
- Target Sample Size
- 96
Eligibility
Recruits 96 No vulnerable populations selected (isVulnerablePopulationSelected: false). Subject information sheets and informed consent forms are provided; separate ICF documents for pregnant partner and infant/infant authorization are included in the dossier. Consent is obtained via the provided ICFs; where infants are relevant, dedicated infant/pediatric authorization documents are included (parent/legally authorised representative consent implied by presence of 'Infant Authorization' ICF). No detailed assent handling procedures are specified in the provided metadata..
- Pregnancy Exclusion
- Cohort B1 and B2: Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false). Subject information sheets and informed consent forms are provided; separate ICF documents for pregnant partner and infant/infant authorization are included in the dossier. Consent is obtained via the provided ICFs; where infants are relevant, dedicated infant/pediatric authorization documents are included (parent/legally authorised representative consent implied by presence of 'Infant Authorization' ICF). No detailed assent handling procedures are specified in the provided metadata.
Inclusion criteria
- {"criterion_text":"- Cohort B1: Complete resection of the primary NSCLC with negative margins\n- Cohort B1: Confirmed stage II-select IIIB (T3N2) NSCLC of non-squamous (adenocarcinoma) histology\n- Cohort B1: ECOG performance status of 0 or 1\n- Cohort B2: Evaluation by the operating attending surgeon and involved medical oncologist prior to study enrollment to verify study eligibility for complete surgical resection with curative intent\n- Cohort B2: Pathologically and/or histologically confirmed Stage II-IIIA and IIIB (T3N2 only) NSCLC of non-squamous (adenocarcinoma) histology\n- Cohort B1 and B2: Documented ALK fusion"}
Exclusion criteria
- {"criterion_text":"- Cohort B1: NSCLC of squamous or mixed histology regardless of the presence of an ALK mutation\n- Cohort B1 and B2: Pregnancy or breastfeeding, or intention of becoming pregnant during the study\n- Cohort B1: Prior exposure to any systemic anti-cancer therapy\n- Cohort B2: Any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post-major bowel resection\n- Cohort B2: Known sensitivity to any component of alectinib, pemetrexed, cisplatin, or carboplatin\n- Cohort B1:Prior exposure to any systemic anti-cancer therapy"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Cohort B1: Incidence, type, and severity of adverse events with onset up to 28 days after the last dose of chemotherapy treatment according to NCI CTCAE v5.0.","definition_or_measurement_approach":"Adverse events are recorded and graded according to NCI CTCAE version 5.0; events with onset up to 28 days after last dose of chemotherapy are included."}
- {"endpoint_text":"- 2. Cohort B2: Investigator-assessed pathologic complete response (inv-pCR)","definition_or_measurement_approach":"Pathologic complete response assessed by the investigator (inv-pCR) per protocol-specified pathology assessment."}
Secondary endpoints
- {"endpoint_text":"- 1. Cohort B1:Incidence, type, and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0). Adverse Events with onset up to 28 days after the last dose of study treatment, or until last on site/discontinuation visit, whichever comes first","definition_or_measurement_approach":"AEs graded per NCI CTCAE v5.0; onset up to 28 days after last dose or until last on-site/discontinuation visit."}
- {"endpoint_text":"- 2. Cohort B2:Investigator-assessed major pathological response (inv-MPR)","definition_or_measurement_approach":"Investigator-assessed major pathological response (inv-MPR) per pathology assessment."}
- {"endpoint_text":"- 3. Cohort B2: Pathologic complete response (pCR) by independent review","definition_or_measurement_approach":"pCR determined by independent review of pathology specimens."}
- {"endpoint_text":"- 4. Cohort B2: Major pathologic response (MPR) by independent review","definition_or_measurement_approach":"MPR determined by independent pathology review."}
- {"endpoint_text":"- 5. Cohort B2: Investigator-assessed overall response rate (ORR) per RECIST v1.1","definition_or_measurement_approach":"ORR assessed by investigator according to RECIST v1.1 criteria."}
- {"endpoint_text":"- 6. Cohort B2: Investigator-assessed event-free survival (EFS)","definition_or_measurement_approach":"Event-free survival as assessed by investigator according to protocol definitions (time-to-event)."}
- {"endpoint_text":"- 7. Cohort B2: OS","definition_or_measurement_approach":"Overall survival (OS) as per protocol-defined survival follow-up."}
- {"endpoint_text":"- 8. Cohort B2: Incidence, severity and type of AEs, with severity determined through use of NCI CTCAE v5.0","definition_or_measurement_approach":"Adverse events graded per NCI CTCAE v5.0."}
- {"endpoint_text":"- 9. Cohort B2: Change from baseline in target safety parameters (vital signs, clinical laboratory test results, ECG parameters)","definition_or_measurement_approach":"Change from baseline measured in vital signs, lab tests, and ECG parameters per scheduled assessments."}
- {"endpoint_text":"- 10. Cohort B2: Frequency of surgery completion, defined as patients who have successfully completed surgery without treatment related delays (> 60 days) from the last dose of neoadjuvant treatment","definition_or_measurement_approach":"Surgery completion frequency defined as surgeries completed without treatment-related delays >60 days from last neoadjuvant dose."}
- {"endpoint_text":"- 11. Cohort B2: Length of treatment related surgical delays, incidence of operative and post-operative complications, and/or reasons for surgical cancellations","definition_or_measurement_approach":"Duration of treatment-related surgical delays, recording of operative/post-operative complications, and documentation of reasons for cancellations."}
Recruitment
- Digital Remote Recruitment
- True, QR code recruitment materials and digital storyboards/leaflets are included (documents titled QR code, storyboard, and digital leaflet are present; intended to link to study information and support remote access to trial information).
- Planned Sample Size
- 96
- Recruitment Window Months
- 17
- Consent Approach
- Informed consent obtained using subject information sheets and informed consent forms. Multiple country- and cohort-specific ICFs are provided (documents available in English, Dutch, French and other country-specific translations). Separate ICFs are included for pregnant partners and infant/infant authorization where applicable. Consent is provided by the participant; for infants/pediatric subjects parental/legally authorised representative consent documents are included. No additional assent procedures are specified in the provided metadata.
Methods
- Belgium: K2_Recruitment material_communication to doctors (channel: communication material to physicians; document associated with Belgium MSC entry id 177515).
- Belgium: K2_Recruitment material_Referral Letter (channel: referral letter to clinicians; associated with Belgium).
- Belgium/Netherlands/other: K1_Recruitment_Arrangements and multiple country-specific K1 recruitment arrangements documents (channel: local recruitment arrangements; associated documents per member state).
- Italy: K1_recruitment arrangements and K2_recruitment materials including Clinical Trial Leaflet and Storyboard (channel: patient-facing leaflets and storyboard materials; associated with Italy MSC id 299025).
- Italy: K2_recruitment material QR code_ Is a clinical research study right for me (channel: QR code on printed/digital materials linking to study information; associated with Italy).
- General: Referral of patients via participating clinicians and specialist surgical/oncology teams (described via referral letters and communication-to-doctors materials in the recruitment documents).
Geography
- Total Number Of Sites
- 33
- Total Number Of Participants
- 54
Austria
- Earliest CTIS Part Ii Submission Date
- 14-01-2025
- Latest Decision Or Authorization Date
- 10-03-2025
- Processing Time Days
- 55
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Stadt Wien Wiener Gesundheitsverbund
- 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
Belgium
- Earliest CTIS Part Ii Submission Date
- 31-01-2025
- Latest Decision Or Authorization Date
- 03-03-2025
- Processing Time Days
- 31
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Medical oncology
- Principal Investigator Name
- Iuliana Angelica Tiotiu-Cepuc
- Principal Investigator Email
- iuliana.tiotiu-cepuc@saintluc.uclouvain.be
- Contact Person Name
- Iuliana Angelica Tiotiu-Cepuc
- Contact Person Email
- iuliana.tiotiu-cepuc@saintluc.uclouvain.be
- Site Name
- UZ Leuven
- Department Name
- Respiratory Oncology
- Principal Investigator Name
- Christophe Dooms
- Principal Investigator Email
- datanursingreo@uzleuven.be
- Contact Person Name
- Christophe Dooms
- Contact Person Email
- datanursingreo@uzleuven.be
Denmark
- Earliest CTIS Part Ii Submission Date
- 05-02-2025
- Latest Decision Or Authorization Date
- 04-03-2025
- Processing Time Days
- 27
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Rigshospitalet
- Department Name
- Onkologisk afdeling
- Principal Investigator Name
- Edyta Maria Urbanska
- Principal Investigator Email
- edyta.maria.urbanska@regionh.dk
- Contact Person Name
- Edyta Maria Urbanska
- Contact Person Email
- edyta.maria.urbanska@regionh.dk
Spain
- Earliest CTIS Part Ii Submission Date
- 22-11-2024
- Latest Decision Or Authorization Date
- 05-03-2025
- Processing Time Days
- 103
- Number Of Sites
- 5
- Number Of Participants
- 7
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Principal Investigator Name
- Luis Paz-Ares
- Principal Investigator Email
- lpazaresr@seom.org
- Contact Person Name
- Luis Paz-Ares
- Contact Person Email
- lpazaresr@seom.org
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Oncology
- 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 Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Alexandre Martínez
- Principal Investigator Email
- amartinezmarti@vhio.net
- Contact Person Name
- Alexandre Martínez
- Contact Person Email
- amartinezmarti@vhio.net
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Oncology
- Principal Investigator Name
- Vanesa Gutiérrez
- Principal Investigator Email
- vgutierrezcald@gmail.com
- Contact Person Name
- Vanesa Gutiérrez
- Contact Person Email
- vgutierrezcald@gmail.com
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Principal Investigator Name
- Ernest Nadal
- Principal Investigator Email
- ernestnadal@gmail.com
- Contact Person Name
- Ernest Nadal
- Contact Person Email
- ernestnadal@gmail.com
Netherlands
- Earliest CTIS Part Ii Submission Date
- 20-02-2025
- Latest Decision Or Authorization Date
- 07-03-2025
- Processing Time Days
- 15
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Lung Diseases
- Principal Investigator Name
- Annemarie Becker
- Principal Investigator Email
- ctis@amsterdamumc.nl
- Contact Person Name
- Annemarie Becker
- Contact Person Email
- ctis@amsterdamumc.nl
Poland
- Earliest CTIS Part Ii Submission Date
- 21-02-2025
- Latest Decision Or Authorization Date
- 28-07-2025
- Processing Time Days
- 157
- Number Of Sites
- 5
- Number Of Participants
- 9
Sites
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworów Płuca i Klatki Piersiowej
- Principal Investigator Name
- Maciej Krzakowski
- Principal Investigator Email
- maciej.krzakowski@nio.gov.pl
- Contact Person Name
- Maciej Krzakowski
- Contact Person Email
- maciej.krzakowski@nio.gov.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Onkologii i Radioterapii
- Principal Investigator Name
- Rafał Dziadziuszko
- Principal Investigator Email
- onkol@gumed.edu.pl
- Contact Person Name
- Rafał Dziadziuszko
- Contact Person Email
- onkol@gumed.edu.pl
- Site Name
- Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
- Department Name
- Oddział Onkologii Klinicznej
- Principal Investigator Name
- Krzysztof Rogoziewicz
- Principal Investigator Email
- onkocwbk@dcopih.pl
- Contact Person Name
- Krzysztof Rogoziewicz
- Contact Person Email
- onkocwbk@dcopih.pl
- Site Name
- Centrum Pulmonologii I Torakochirurgii W Bystrej
- Department Name
- Oddział Pulmonologiczno-Onkologiczny z Chemioterapią
- Principal Investigator Name
- Beata Kania-Zembaczyńska
- Principal Investigator Email
- oddzial1@szpitalbystra.pl
- Contact Person Name
- Beata Kania-Zembaczyńska
- Contact Person Email
- oddzial1@szpitalbystra.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
- kstencel@wcpit.org
- Contact Person Name
- Katarzyna Stencel
- Contact Person Email
- kstencel@wcpit.org
France
- Earliest CTIS Part Ii Submission Date
- 17-01-2025
- Latest Decision Or Authorization Date
- 28-07-2025
- Processing Time Days
- 192
- Number Of Sites
- 8
- Number Of Participants
- 15
Sites
- Site Name
- Centre Francois Baclesse
- Department Name
- Oncologie
- Principal Investigator Name
- Hubert Curcio
- Principal Investigator Email
- h.curcio@baclesse.unicancer.fr
- Contact Person Name
- Hubert Curcio
- Contact Person Email
- h.curcio@baclesse.unicancer.fr
- Site Name
- Centre Leon Berard
- Department Name
- Department of Medical Oncology
- Principal Investigator Name
- Aurélie Swalduz
- Principal Investigator Email
- aurelie.swalduz@lyon.unicancer.fr
- Contact Person Name
- Aurélie Swalduz
- Contact Person Email
- aurelie.swalduz@lyon.unicancer.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Pneumology department
- Principal Investigator Name
- Céline Mascaux
- Principal Investigator Email
- celine.mascaux@chru-strasbourg.fr
- Contact Person Name
- Céline Mascaux
- Contact Person Email
- celine.mascaux@chru-strasbourg.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Pulmonology
- Principal Investigator Name
- Michael Duruisseaux
- Principal Investigator Email
- Ghe.arc-pneumo@chu-lyon.fr
- Contact Person Name
- Michael Duruisseaux
- Contact Person Email
- Ghe.arc-pneumo@chu-lyon.fr
- Site Name
- Centre Hospitalier Intercommunal De Cornouaille
- Department Name
- pneumology oncology
- Principal Investigator Name
- Michel André
- Principal Investigator Email
- michel.andre@ch-cornouaille.fr
- Contact Person Name
- Michel André
- Contact Person Email
- michel.andre@ch-cornouaille.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Thoracy oncology unit
- 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 Regional De Marseille
- Department Name
- CEPCM
- 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
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Pneumology
- Principal Investigator Name
- Claire Bardel
- Principal Investigator Email
- claire.bardel@chu-bordeaux.fr
- Contact Person Name
- Claire Bardel
- Contact Person Email
- claire.bardel@chu-bordeaux.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 19-12-2024
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 497
- Number Of Sites
- 10
- Number Of Participants
- 10
Sites
- 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
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Emilio Bria
- Principal Investigator Email
- emilio.bria@policlinicogemelli.it
- Contact Person Name
- Emilio Bria
- Contact Person Email
- emilio.bria@policlinicogemelli.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Oncologia
- Principal Investigator Name
- Ilaria Attili
- Principal Investigator Email
- ilaria.attili@ieo.it
- Contact Person Name
- Ilaria Attili
- Contact Person Email
- ilaria.attili@ieo.it
- Site Name
- Istituto Tumori Bari Giovanni Paolo II
- Department Name
- Oncologia
- Principal Investigator Name
- Domenico Galetta
- Principal Investigator Email
- galetta@oncologico.bari.it
- Contact Person Name
- Domenico Galetta
- Contact Person Email
- galetta@oncologico.bari.it
- Site Name
- Cliniche Gavazzeni S.p.A.
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Chiara Catania
- Principal Investigator Email
- chiara.catania@gavazzeni.it
- Contact Person Name
- Chiara Catania
- Contact Person Email
- chiara.catania@gavazzeni.it
- Site Name
- Istituto Oncologico Veneto
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Giulia Pasello
- Principal Investigator Email
- giulia.pasello@iov.veneto.it
- Contact Person Name
- Giulia Pasello
- Contact Person Email
- giulia.pasello@iov.veneto.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- 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
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Ematologia ed Oncologia
- Principal Investigator Name
- Diego Signorelli
- Principal Investigator Email
- diego.signorelli@ospedaleniguarda.it
- Contact Person Name
- Diego Signorelli
- Contact Person Email
- diego.signorelli@ospedaleniguarda.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l. (duplicate site entry exists in dataset)
- Department Name
- Oncologia
- Principal Investigator Name
- Ilaria Attili
- Principal Investigator Email
- ilaria.attili@ieo.it
- Contact Person Name
- Ilaria Attili
- Contact Person Email
- ilaria.attili@ieo.it
- Site Name
- Hospital Santa Maria Della Misericordia (additional listed site entry)
- 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
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Fortrea Inc.
- Responsibilities
- sponsorDuties: [{'id':856145,'code':'4'}]
- Name
- Almac Group Limited
- Responsibilities
- Randomization (sponsorDuties code 15, value 'Randomization')
- Name
- Labcorp Central Laboratory Services LP
- Responsibilities
- sponsorDuties: [{'id':856156,'code':'4'}]
- Name
- Q2 Solutions LLC
- Responsibilities
- sponsorDuties: [{'id':856154,'code':'4'}]
- Name
- Q Squared Solutions (Beijing) Co. Ltd.
- Responsibilities
- sponsorDuties: [{'id':856149,'code':'4'}]
- Name
- CellCarta
- Responsibilities
- sponsorDuties: [{'id':856150,'code':'4'}]
- Name
- Kayentis
- Responsibilities
- Monitoring (sponsorDuties code 15, value 'Monitoring')
Third parties
- {"country":"Canada","full_name":"Axon Communications Inc.","duties_or_roles":"sponsorDuties: [{'id':856155,'code':'4'}]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"sponsorDuties: [{'id':856145,'code':'4'}]","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Median Technologies","duties_or_roles":"sponsorDuties: [{'id':856148,'code':'4'}]","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Group Limited","duties_or_roles":"sponsorDuties: [{'id':856153,'code':'15','value':'Randomization'}]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"sponsorDuties: [{'id':856146,'code':'4'}]","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Kayentis","duties_or_roles":"sponsorDuties: [{'id':856151,'code':'15','value':'Monitoring'}]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties: [{'id':856156,'code':'4'}]","organisation_type":"Pharmaceutical company"}
- {"country":"China","full_name":"Q Squared Solutions (Beijing) Co. Ltd.","duties_or_roles":"sponsorDuties: [{'id':856149,'code':'4'}]","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"sponsorDuties: [{'id':856150,'code':'4'}]","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"sponsorDuties: [{'id':856154,'code':'4'}]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"sponsorDuties: [{'id':856152,'code':'4'}]","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q2q Communications Limited","duties_or_roles":"sponsorDuties: [{'id':856147,'code':'15','value':'Meeting Organizer'}]","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Alectinib (Alecensa)
- Active Substance
- ALECTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- prodAuthStatus: 1
- Maximum Dose
- 1200 mg (maxDailyDoseAmount: 1200, doseUom: mg)
- Investigational Product Name
- Pemetrexed (Pemetrexed Pfizer / Accord / Fresenius Kabi / PEMETREXED)
- Active Substance
- PEMETREXED
- Modality
- Small molecule
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- prodAuthStatus: 2 / part-coded entries (multiple marketing authorisation entries present)
- Maximum Dose
- 500 mg/m2 (maxDailyDoseAmount: 500, doseUom: mg/m2)
- Investigational Product Name
- Carboplatin (multiple brands)
- Active Substance
- CARBOPLATIN
- Modality
- Small molecule
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- prodAuthStatus: 2 (marketing authorisations present for listed products)
- Maximum Dose
- 750 mg (maxDailyDoseAmount: 750, doseUom: mg)
- Investigational Product Name
- Cisplatin (multiple brands)
- Active Substance
- CISPLATIN
- Modality
- Small molecule
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- prodAuthStatus: 2 (marketing authorisations present for listed products)
- Maximum Dose
- 75 mg/m2 (maxDailyDoseAmount: 75, doseUom: mg/m2)
- Combination Treatment
- Yes
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