Clinical trial • Phase II/III • Oncology
Alectinib for Advanced or metastatic non-small cell lung cancer
Phase II/III trial of Alectinib for Advanced or metastatic non-small cell lung cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced or metastatic non-small cell lung cancer
- Trial Stage
- Phase II/III
- Drug Modality
- Small molecule|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 29-04-2024
- First CTIS Authorization Date
- 11-06-2024
Trial design
Platinum-based chemotherapy comparator (atezolizumab compared with platinum-based chemotherapy in Cohort C). SmPC/comparator products referenced in CTIS documents include carboplatin, pemetrexed, cisplatin, docetaxel, gemcitabine (standard chemotherapies listed in product/SmPC documents). Specific doses and schedules are not specified in the available data.-controlled, adaptive Phase II/III trial in Belgium, Germany, Spain and others.
- Comparator
- Platinum-based chemotherapy comparator (atezolizumab compared with platinum-based chemotherapy in Cohort C). SmPC/comparator products referenced in CTIS documents include carboplatin, pemetrexed, cisplatin, docetaxel, gemcitabine (standard chemotherapies listed in product/SmPC documents). Specific doses and schedules are not specified in the available data.
- Adaptive
- True, contains dose-escalation elements (e.g., DLTs and escalating alectinib doses in RET+ patients in Cohort B; Cohort G evaluates two doses of divarasib). Interim or stopping rules are not detailed in the available data.
- Biomarker Stratified
- True: selection/stratification is by actionable somatic mutations detected by the FoundationOne Liquid Companion Diagnostic (F1LCDx) — cohorts defined by ALK+, RET+, ROS1+, BRAF V600+, EGFR exon 20+, KRAS G12C+; Cohort C is stratified by blood tumor mutational burden (bTMB) with primary PP1 and secondary PP2 populations.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 344
Eligibility
Recruits 344 Vulnerable population selected (populationOfTrialSubjects.isVulnerablePopulationSelected = true). Subject information sheets and informed consent forms (L1_SIS and ICF) are provided for multiple cohorts (documents listed in the CTIS record). No explicit assent procedures are described in the available data; informed consent is obtained using the ICF/SIS documents..
- Pregnancy Exclusion
- Women who are pregnant or lactating
- Vulnerable Population
- Vulnerable population selected (populationOfTrialSubjects.isVulnerablePopulationSelected = true). Subject information sheets and informed consent forms (L1_SIS and ICF) are provided for multiple cohorts (documents listed in the CTIS record). No explicit assent procedures are described in the available data; informed consent is obtained using the ICF/SIS documents.
Inclusion criteria
- {"criterion_text":"- Histologically or cytologically confirmed diagnosis of unresectable Stage IIIb not amenable to treatment with combined modality chemoradiation (advanced) or Stage IV (metastatic) NSCLC\n- Measurable disease (as defined by RECIST, v1.1)\n- Adequate recovery from most recent systemic or local treatment for cancer\n- Adequate organ function\n- Life expectancy >=12 weeks\n- For female patients of childbearing potential and male patients, willingness to use acceptable methods of contraception"}
Exclusion criteria
- {"criterion_text":"- Inability to swallow oral medication\n- Women who are pregnant or lactating\n- Symptomatic, untreated CNS metastases Patients with treated and/or asymptomatic brain metastases may still be eligible for treatment on the study depending on individual cohort requirements; see the cohort-specific appendices for details regarding eligibility\n- History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate ≥ 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ of breast, or Stage I uterine cancer\n- Significant cardiovascular disease\n- Known active or uncontrolled HIV infection"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Investigator-assessed ORR based on confirmed objective response (Cohorts A, B, D, and F)","definition_or_measurement_approach":"Investigator-assessed objective response rate based on confirmed objective response."}
- {"endpoint_text":"- 2. Investigator-assessed PFS according to RECIST v1.1 (Cohort C) in bTMB the primary population of patients with a bTMB level equal to or greater than the higher validated cutoff (PP1)","definition_or_measurement_approach":"Investigator-assessed progression-free survival per RECIST v1.1 in the bTMB primary population (bTMB ≥ validated cutoff)."}
- {"endpoint_text":"- 3. Investigator-assessed 12-month time in response (TIR) per RECIST v1.1 (Cohort E)","definition_or_measurement_approach":"Investigator-assessed time in response at 12 months measured per RECIST v1.1."}
- {"endpoint_text":"- 4. Incidence, type, and severity of adverse events (based on the NCI CTCAE v5.0), (Cohorts G)","definition_or_measurement_approach":"Safety assessment: incidence, type and severity of AEs graded by NCI CTCAE v5.0."}
- {"endpoint_text":"- 5. Change from baseline in targeted vital signs, clinical laboratory test results, ECG parameters (Cohorts G)","definition_or_measurement_approach":"Changes from baseline in specified vital signs, labs and ECG parameters as measured during study assessments."}
- {"endpoint_text":"- 6. Tolerability of treatment as assessed through use of the NCI PRO-CTCAE (Cohort G) Frequency of patients' response of the degree they are troubled with treatment symptoms, as assessed through use of the single-item EORTC Item List (IL46) (Cohort G)","definition_or_measurement_approach":"Patient-reported tolerability assessed via NCI PRO-CTCAE and a single-item EORTC measure (IL46) capturing degree of symptom bother."}
Secondary endpoints
- {"endpoint_text":"- 1. Investigator-assessed DOR, CBR, and PFS per RECIST v1.1 (Cohorts A, B, and D)","definition_or_measurement_approach":"Duration of response (DOR), clinical benefit rate (CBR), and progression-free survival as assessed by investigator per RECIST v1.1."}
- {"endpoint_text":"- 2. IRF-assessed ORR, DOR, CBR, and PFS per RECIST v1.1 (Cohorts A, B, and D)","definition_or_measurement_approach":"Independent review facility-assessed ORR, DOR, CBR, and PFS per RECIST v1.1."}
- {"endpoint_text":"- 3. IRF-assessed PFS, ORR, and DOR according to RECIST v1.1 (Cohort C and F)","definition_or_measurement_approach":"IRF-assessed PFS, ORR and DOR per RECIST v1.1 for Cohorts C and F."}
- {"endpoint_text":"- 4. Investigator-assessed ORR, and DOR according to RECIST v1.1 (Cohort C)","definition_or_measurement_approach":"Investigator-assessed ORR and DOR per RECIST v1.1 in Cohort C."}
- {"endpoint_text":"- 5. Investigator- and IRF-assessed time to CNS progression according to RECIST v1.1 (Cohort D)","definition_or_measurement_approach":"Time to confirmed CNS progression assessed by investigator and IRF per RECIST v1.1."}
- {"endpoint_text":"- 6. OS (Cohorts A, B, D, E, and F)","definition_or_measurement_approach":"Overall survival measured from randomization/enrollment to death from any cause."}
- {"endpoint_text":"- 7. Investigator-assessed PFS rates at 6-month and 1-year landmark timepoints (Cohort C)","definition_or_measurement_approach":"PFS rates at 6-month and 1-year landmark timepoints assessed by investigator."}
- {"endpoint_text":"- 8. Incidence, type, and severity of adverse events (based on the NCI CTCAE v4.0)(Cohorts A-F)","definition_or_measurement_approach":"AE incidence, type and severity graded by NCI CTCAE v4.0 for Cohorts A-F."}
- {"endpoint_text":"- 9. Changes in vital signs, physical findings, and clinical laboratory results during and following administration of protocol-specified IMPs (Cohorts A, B, D, E, and F)","definition_or_measurement_approach":"Changes in vital signs, physical exam findings and laboratory results collected during and after IMP administration."}
- {"endpoint_text":"- 10. DLTs, if any, associated with alectinib at escalating doses in RET+ patients (Cohort B)","definition_or_measurement_approach":"Dose-limiting toxicities associated with escalating alectinib doses in RET+ patients."}
- {"endpoint_text":"- 11. PK parameters of alectinib in RET+ patients (Cohort B)","definition_or_measurement_approach":"Pharmacokinetic parameters of alectinib measured in RET+ patients."}
- {"endpoint_text":"- 12. Population PK analysis for entrectinib (Cohort D)","definition_or_measurement_approach":"Population pharmacokinetic analysis for entrectinib."}
- {"endpoint_text":"- 13. Time to confirmed deterioration (TTCD) in patient-reported lung cancer symptoms of cough, dyspnea, and chest pain, as measured by the symptoms in lung cancer (SILC) (Cohort A, B, D, E, F)","definition_or_measurement_approach":"TTCD in patient-reported cough, dyspnea, and chest pain measured by SILC questionnaire."}
- {"endpoint_text":"- 14. Proportion of patients who improved compared with baseline in patient-reported lung cancer symptoms of cough, dyspnea, and chest pain and TTD as measured by SILC (Cohorts A, B, C, D, E, and F)","definition_or_measurement_approach":"Proportion of patients with symptom improvement vs baseline per SILC and time to deterioration."}
- {"endpoint_text":"- 15. Proportion of patients presenting with measurable CNS disease at baseline who improve compared with baseline in patient-reported cognitive function, fatigue, health-related quality of life (HRQoL), headache, and vision disorder per the corresponding scales of the EORTC QLQ-C30 and BN20 (Cohort D)","definition_or_measurement_approach":"Proportion improving in cognitive function, fatigue, HRQoL, headache, vision as measured by EORTC QLQ-C30 and BN20 scales."}
- {"endpoint_text":"- 16. Mean change from baseline in HRQoL, patient functioning, and symptoms as measured by the EORTC QLQ-C30, QLQ-LC-13 or SILC (Cohorts A, B, C, D, E, and F)","definition_or_measurement_approach":"Mean change from baseline in HRQoL and symptoms measured by EORTC QLQ-C30, QLQ-LC-13 or SILC."}
- {"endpoint_text":"- 17. Health status as assessed by the EQ-5D-5L questionnaire (Cohorts A, B, C, D, E, and F)","definition_or_measurement_approach":"Health status measured by EQ-5D-5L questionnaire."}
- {"endpoint_text":"- 18. Relationship between circulating biomarkers related to alectinib exposure and efficacy (Cohorts A and B), to atezolizumab efficacy (Cohort C) to entrectinib efficacy (Cohort D), atezo + cobi + vem efficacy (Cohort E), and atezo + bev + carboplatin + pemetrexed efficacy (Cohort F)","definition_or_measurement_approach":"Analysis of circulating biomarkers in relation to exposure and efficacy for respective cohorts."}
- {"endpoint_text":"- 19. OS in bTMB PP1 (Cohort C)","definition_or_measurement_approach":"Overall survival in the bTMB primary population (PP1) for Cohort C."}
- {"endpoint_text":"- 20. Investigator-assessed PFS according to RECIST v1.1 in bTMB the secondary population of all patients who are bTMB-positive, which is the intent-to-treat (ITT) population in this cohort (PP2) [Cohort C]","definition_or_measurement_approach":"Investigator-assessed PFS per RECIST v1.1 in the bTMB-positive ITT population (PP2) for Cohort C."}
- {"endpoint_text":"- 21. OS in bTMB PP2 (Cohort C)","definition_or_measurement_approach":"Overall survival in the bTMB secondary population (PP2) for Cohort C."}
- {"endpoint_text":"- 22. Investigator and IRF-assessed ORR, DOR, and PFS per RECIST v1.1 (Cohort E)","definition_or_measurement_approach":"Investigator- and IRF-assessed ORR, DOR, and PFS per RECIST v1.1 in Cohort E."}
- {"endpoint_text":"- 23. Investigator-assessed DOR and PFS per RECIST v1.1 (Cohort F)","definition_or_measurement_approach":"Investigator-assessed duration of response and PFS per RECIST v1.1 for Cohort F."}
- {"endpoint_text":"- 24. 9-month TIR (Cohort E)","definition_or_measurement_approach":"9-month time in response for Cohort E per RECIST v1.1."}
- {"endpoint_text":"- 25. 12-month TIR (Cohort E)","definition_or_measurement_approach":"12-month time in response for Cohort E per RECIST v1.1."}
- {"endpoint_text":"- 26. Serum concentration of atezo at specified timepoints (Cohort E and F)","definition_or_measurement_approach":"Serum concentrations of atezolizumab measured at predefined timepoints."}
- {"endpoint_text":"- 27. Presence of ADAs against atezo during the study relative to the presence of ADAs at baseline (Cohort E and F)","definition_or_measurement_approach":"Assessment of anti-drug antibodies (ADAs) against atezolizumab during study versus baseline."}
- {"endpoint_text":"- 28. Plasma concentrations of divarasib at specified timepoints","definition_or_measurement_approach":"Plasma concentrations of divarasib measured at specified timepoints."}
Recruitment
- Planned Sample Size
- 344
- Recruitment Window Months
- 129
- Consent Approach
- Informed consent is required using subject information sheets and informed consent forms (L1_SIS and ICF documents exist for multiple cohorts and contexts, including pregnant-partner cohort documents). Multiple cohort-specific ICFs are included in the CTIS documents. Translations of study documents/protocol synopsis are available in French, Polish, Spanish and protocol synopses also available in Italian, Dutch and German; English-language materials are available as well. No specific assent process is described in the available data.
Geography
- Total Number Of Sites
- 40
- Total Number Of Participants
- 344
Belgium
- Earliest CTIS Part Ii Submission Date
- 23-05-2024
- Latest Decision Or Authorization Date
- 17-06-2024
- Processing Time Days
- 25
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- UZ Leuven
- Department Name
- Respiratory Oncology
- Contact Person Name
- Christophe Dooms
- Contact Person Email
- datanursingreo@uzleuven.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Oncology
- Contact Person Name
- Frank Aboubakar
- Contact Person Email
- frank.aboubakar@saintluc.uclouvain.be
- Site Name
- UZ Brussel
- Department Name
- Oncology
- Contact Person Name
- Lore Decoster
- Contact Person Email
- datamanagement.oncologie@uzbrussel.be
Germany
- Earliest CTIS Part Ii Submission Date
- 23-05-2024
- Latest Decision Or Authorization Date
- 13-06-2024
- Processing Time Days
- 21
- Number Of Sites
- 3
- Number Of Participants
- 16
Sites
- Site Name
- Asklepios Klinik Gauting GmbH
- Department Name
- Asklepios Fachkliniken München-Gauting Onkologie
- Contact Person Name
- Niels Reinmuth
- Contact Person Email
- n.reinmuth@asklepios.com
- Site Name
- Klinikum Esslingen GmbH
- Department Name
- KLINIK FÜR Kardiologie, Angiologie und Pneumologie
- Contact Person Name
- Martin Faehling
- Contact Person Email
- m.faehling@klinikum-esslingen.de
- Site Name
- HELIOS Dr. Horst Schmidt Kliniken Wiesbaden GmbH
- Department Name
- Innere Medizin III: Hämatologie/Onkologie/ Palliativmedizin
- Contact Person Name
- Natalia Heinz
- Contact Person Email
- studien.onkologie@hsk-wiesbaden.de
Spain
- Earliest CTIS Part Ii Submission Date
- 23-05-2024
- Latest Decision Or Authorization Date
- 11-06-2024
- Processing Time Days
- 19
- Number Of Sites
- 17
- Number Of Participants
- 73
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncología
- Contact Person Name
- Luis Paz Arez Rodriguez
- Contact Person Email
- lpazaresr@seom.org
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncología
- Contact Person Name
- Ernest Nadal Alforja
- Contact Person Email
- ernestnadal@gmail.com
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Oncología
- Contact Person Name
- Mariano Provencio Pulla
- Contact Person Email
- mprovencio.ensayosclinicos@gmail.com
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Oncología
- Contact Person Name
- Amelia Insa Molla
- Contact Person Email
- ameliainsamolla@gmail.com
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Oncología
- Contact Person Name
- Belén Rubio Viqueira
- Contact Person Email
- belen.rubio@quironsalud.es
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncología
- Contact Person Name
- Gema García Ledo
- Contact Person Email
- gmgarcialedo@hmhospitales.com
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Oncología
- Contact Person Name
- Manuel Cobo Dols
- Contact Person Email
- manuelcobodols@yahoo.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncología
- Contact Person Name
- Noemí Reguart Aransay
- Contact Person Email
- NREGUART@clinic.cat
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Oncología
- Contact Person Name
- Rosa Álvarez Álvarez
- Contact Person Email
- rosa.alvarez.al@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncología
- Contact Person Name
- Enriqueta Felip Font
- Contact Person Email
- efelip@vhio.net
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Oncología
- Contact Person Name
- Rafael López López
- Contact Person Email
- rafa.lopez.lopez@gmail.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncología
- Contact Person Name
- Reyes Bernabé Caro
- Contact Person Email
- reyesbernab@yahoo.es
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Oncología
- Contact Person Name
- Manuel Cobo Dols
- Contact Person Email
- manuelcobodols@yahoo.es
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Oncología
- Contact Person Name
- Teresa Morán Bueno
- Contact Person Email
- mmoran@iconcologia.net
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncología
- Contact Person Name
- Pilar Garrido López
- Contact Person Email
- pilargarridol@gamil.com
- Site Name
- Hospital General Universitario Dr. Balmis
- Department Name
- Oncología
- Contact Person Name
- Bartomeu Massuti Sureda
- Contact Person Email
- bmassutis@seom.org
Poland
- Earliest CTIS Part Ii Submission Date
- 23-05-2024
- Latest Decision Or Authorization Date
- 03-07-2024
- Processing Time Days
- 41
- Number Of Sites
- 6
- Number Of Participants
- 40
Sites
- Site Name
- Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
- Department Name
- Oddział Onkologii z Pododdziałem Chemioterapii
- Contact Person Name
- Andrzej Każarnowicz
- Contact Person Email
- sekretariat@pulmonologia.olsztyn.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Onkologii i Radioterapii
- Contact Person Name
- Rafał Dziadziuszko
- Contact Person Email
- rafald@gumed.edu.pl
- Site Name
- Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
- Department Name
- Oddział Onkologii Klinicznej z Pododdziałem Dziennej Chemioterapii
- Contact Person Name
- Katarzyna Stencel
- Contact Person Email
- kstencel@wcpit.pl
- Site Name
- Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
- Department Name
- Oddział Onkologii z Pododdziałem Diagnostyki Nowotworów Klatki Piersiowej
- Contact Person Name
- Grzegorz Czyżewicz
- Contact Person Email
- czyzeg@szpitaljp2.krakow.pl
- Site Name
- Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy
- Department Name
- Oddział III - Chorób Płuc z Pododdziałem Onkologicznym
- Contact Person Name
- Aleksandra Szczęsna
- Contact Person Email
- ola_szczesna@outlook.com
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworów Płuca i Klatki Piersiowej
- Contact Person Name
- Dariusz Kowalski
- Contact Person Email
- dariusz.kowalski@nio.gov.pl
Italy
- Earliest CTIS Part Ii Submission Date
- 23-05-2024
- Latest Decision Or Authorization Date
- 17-06-2024
- Processing Time Days
- 25
- Number Of Sites
- 9
- Number Of Participants
- 41
Sites
- Site Name
- European Institute Of Oncology S.r.l.
- Department Name
- Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
- Contact Person Name
- Filippo De Marinis
- Contact Person Email
- filippo.demarinis@ieo.it
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- S.C.D.U. di Oncologia Toracica
- Contact Person Name
- Silvia Novello
- Contact Person Email
- silvia.novello@unito.it
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
- Department Name
- Oncologia Medica
- Contact Person Name
- Lucia Bonomi
- Contact Person Email
- lbonomi@asst-pg23.it
- 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
- Contact Person Name
- Angelo Delmonte
- Contact Person Email
- angelo.delmonte@irst.emr.it
- Site Name
- Fondazione IRCCS San Gerardo Dei Tintori
- Department Name
- ASST DI MONZA
- Contact Person Name
- Diego Cortinovis
- Contact Person Email
- diegoluigi.cortinovis@irccs-sangerardo.it
- Site Name
- Centro Di Riferimento Oncologico Di Aviano
- Department Name
- Irccs Centro Di Riferimento Oncologico (CRO)
- Contact Person Name
- Alessandra Bearz
- Contact Person Email
- abearz@cro.it
- Site Name
- Azienda Socio Sanitaria Territoriale Di Cremona
- Department Name
- ASST di Cremona - Azienda Socio Sanitaria Territoriale di Cremona
- Contact Person Name
- Stefano Panni
- Contact Person Email
- stefano.panni@asst-cremona.it
- Site Name
- San Camillo Forlanini Hospital
- Department Name
- Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1
- Contact Person Name
- Serena Ricciardi
- Contact Person Email
- sricciardi@scamilloforlanini.rm.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
- Contact Person Name
- Alessandro Morabito
- Contact Person Email
- a.morabito@istitutotumori.na.it
France
- Earliest CTIS Part Ii Submission Date
- 23-05-2024
- Latest Decision Or Authorization Date
- 12-06-2024
- Processing Time Days
- 20
- Number Of Sites
- 2
- Number Of Participants
- 90
Sites
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Pneumology
- Contact Person Name
- Charles Ricordel
- Contact Person Email
- charles.ricordel@chu-rennes.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pneumology
- Contact Person Name
- Jacques Cadranel
- Contact Person Email
- jacques.cadranel@aphp.fr
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- 1
- Name
- Almac Clinical Technologies LLC
- Responsibilities
- 3
- Name
- Icon Development Solutions LLC
- Responsibilities
- 4
Third parties
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"1","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"3","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Exco Intouch Limited","duties_or_roles":"7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"Foundation Medicine GmbH","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Median Technologies","duties_or_roles":"15","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Alectinib
- Modality
- Small molecule
- Investigational Product Name
- Entrectinib
- Modality
- Small molecule
- Investigational Product Name
- Atezolizumab
- Modality
- Monoclonal antibody
- Investigational Product Name
- Cobimetinib
- Modality
- Small molecule
- Investigational Product Name
- Vemurafenib
- Modality
- Small molecule
- Investigational Product Name
- Bevacizumab
- Modality
- Monoclonal antibody
- Investigational Product Name
- Carboplatin
- Modality
- Small molecule
- Investigational Product Name
- Pemetrexed
- Modality
- Small molecule
- Investigational Product Name
- Divarasib
- Modality
- Small molecule
- Combination Treatment
- Yes
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