Clinical trial • Phase II/III • Oncology

DOSTARLIMAB for Non-small cell lung cancer

Phase II/III trial of DOSTARLIMAB for Non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer
Trial Stage
Phase II/III
Drug Modality
Monoclonal antibody|Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
19-01-2024
First CTIS Authorization Date
21-02-2024

Trial design

Randomised, open-label, arm c: docetaxel (docetaxel hikma; docetaxel iv; max dose stated 75 mg/m2). arm b comparator: dostarlimab (jemperli 500 mg concentrate for solution for infusion) + docetaxel (docetaxel hikma 75 mg/m2 iv). detailed schedule/frequency not specified in the available data.-controlled Phase II/III trial in Sweden, Belgium, Finland and others.

Randomised
Yes
Open Label
Yes
Comparator
Arm C: Docetaxel (Docetaxel Hikma; docetaxel IV; max dose stated 75 mg/m2). Arm B comparator: Dostarlimab (JEMPERLI 500 mg concentrate for solution for infusion) + Docetaxel (Docetaxel Hikma 75 mg/m2 IV). Detailed schedule/frequency not specified in the available data.
Target Sample Size
320
Trial Duration For Participant
1188

Eligibility

Recruits 320 Vulnerable population selected. The protocol requires written informed consent from participants as described in APPENDIX 5; participants must be ≥18 years old (≥19 years in Korea). No specific assent procedures for minors are provided in the available documents..

Vulnerable Population
Vulnerable population selected. The protocol requires written informed consent from participants as described in APPENDIX 5; participants must be ≥18 years old (≥19 years in Korea). No specific assent procedures for minors are provided in the available documents.

Inclusion criteria

  • {"criterion_text":"- \"Participant is ≥18 years old, is able to understand the study procedures, and agrees to participate in the study by providing written informed consent (as described in APPENDIX 5), which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Note: Participants in Korea are eligible if they are 19 years or older at the time consent is obtained.\" \n- \"Participant has histologically or cytologically proven advanced or metastatic NSCLC, and only squamous or nonsquamous cell carcinoma.\" \n- \"Participant has received no more than 2 prior lines of therapy for advanced or metastatic disease, which must only include a platinum-based (e.g., cisplatin, carboplatin) doublet chemotherapy regimen and an anti-PD-1 or anti-PD-L1 antibody (no other biologic alone or in combination; novel combinations are not allowed). Participants previously treated with targeted therapies, including angiogenesis inhibitors (e.g., bevacizumab, ramucirumab, lenvatinib), are not eligible. Two components of treatment must have been received in the same line or as separate lines of therapy as follows: • A maximum of 1 line of therapy containing a platinum-based chemotherapy in the metastatic setting and • A maximum of 1 line of therapy containing an anti-PD-1 or anti-PD-L1 antibody Note the following: − An anti-PD-1 or anti-PD-L1 antibody received during a previous clinical study meets this requirement if the antibody has been approved for an indication in at least 1 country. − Participants from the Phase 3 PACIFIC clinical study (NCT02125461) who received the experimental regimen (chemoradiotherapy followed by durvalumab) (Antonia, 2017) or participants who received a regimen similar to the PACIFIC regimen (chemoradiotherapy followed by an anti-PD-1 or anti-PD-L1 antibody) as part of standard of care and have relapsed within 1 year of the first dose of chemoradiotherapy fulfill the protocol requirement for platinum-based chemotherapy and anti-PD-1 or anti-PD-L1 antibody therapy. These regimens are considered 1 line of therapy for stratification purposes. − The anti-PD-1 or anti-PD-L1 antibody can be administered with the platinum-based chemotherapy, and this is considered 1 line of therapy with both agents and no other lines are allowed. − The anti-PD-1 or anti-PD-L1 antibody may be counted as a prior treatment if the antibody is approved in at least 1 country for the treatment of cancer. − Participants who have completed 2 years of treatment with pembrolizumab or another anti-PD-1 or anti-PD-L1 antibody, discontinued from that therapy, experienced disease progression, and are then retreated with an anti-PD-1 or anti-PD-L1 antibody will be considered as having had 1 line of anti-PD-1 or anti-PD-L1 therapy. − Adjuvant or neoadjuvant systemic anticancer therapy will not count toward the 2 lines of therapy unless disease recurs during the first year following the start of adjuvant chemotherapy.\" \n- \"Participant has measurable disease, that is, presenting with at least 1 measurable lesion per RECIST v1.1 as determined by the local site Investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if disease progression has been demonstrated in such lesions and if there are other target lesions. If there is only 1 target lesion that was previously irradiated, the participant is not eligible. See APPENDIX 1 for the definition of a measurable lesion.\" \n- \"Participant has documented radiological disease progression on prior platinum-based chemotherapy and on prior anti-PD-1 or anti-PD-L1 therapy according to RECIST v1.1.\" \n- \"Participant agrees to submit an archival FFPE tumor tissue specimen that was collected on or after diagnosis of metastatic disease from location(s) not irradiated prior to biopsy. Both tissue block and freshly cut slides are acceptable. If archival tissue is not available, the participant must undergo biopsy prior to study entry. See the Study Reference Manual for further details. a. Participants are also encouraged, but not required, to have a fresh tumor tissue biopsy of a primary or metastatic tumor prior to dosing (samples will be used to enable biomarker analysis). For a full list of Inclusion criteria please refer to the Study Protocol Section 5.1 Inclusion Criteria pg57-61 \""}

Exclusion criteria

  • {"criterion_text":"- \"Participant has been previously treated with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent that resulted in permanent discontinuation due to an AE.\" \n- \"Participant has had major surgery within 3 weeks prior to the first dose of study treatment or has not adequately recovered from any AEs (Grade ≤1) and/or complications from any major surgery. Surgical implantation of a port catheter is not exclusionary.\" \n- \"Participant has known new or progressive brain metastases and/or leptomeningeal metastases. Participants who have received prior therapy for their brain metastases and have radiologically stable central nervous system disease may participate, provided they are neurologically stable for at least 4 weeks before study entry and are off corticosteroids within 3 days prior to the first dose of study treatment.\" \n- \"Participant has tested positive for the following at Screening or within 3 months before the first dose of study treatment: a. Presence of hepatitis B surface antigen. b. Presence of hepatitis C antibody in the absence of an RNA test for hepatitis C virus. If a confirmatory RNA test is available, a positive test result will exclude a participant, while a negative test result (indicating absence of active infection) will allow the participant to enter into the study.\" \n- \"Participant has an active infection requiring systemic therapy within 1 week prior to the anticipated first dose of study treatment.\" \n- \"Participant has known HIV (positive for HIV-1 or HIV-2 antibodies). For a full list of Exclusion criteria please refer to the Study Protocol Section 5.2 Exclusion Criteria pg61-64\" \n- \"Participant has an additional malignancy or a history of prior malignancy, with the exception of adequately treated basal or squamous skin cancer, cervical carcinoma in situ, or bladder carcinoma in situ without evidence of disease, or had a malignancy treated with curative intent and with no evidence of disease recurrence for 5 years since the initiation of that therapy.\" \n- \"Participant has been previously treated with an anti-TIM-3 or anti-CTLA-4 agent or docetaxel.\" \n- \"Participant has a documented sensitizing EGFR, ALK, or ROS-1 mutation. Participants whose tumors have not been tested for these driver mutations and therefore who have unknown driver mutation status are not eligible. Participants with squamous histology do not need to be tested for these driver mutations.\" \n- \"Participant had radiological or clinical disease progression (ie, worsening performance status, clinical symptoms, and laboratory data) ≤8 weeks after initiation of prior anti-PD-1 or anti-PD-L1 antibody. The clinical disease progression should have been confirmed by a subsequent radiological scan.\" \n- \"Participant has received radiation to the lung that is >30 Gy within 6 months prior to the first dose of study treatment.\" \n- \"Participant has completed palliative radiotherapy within 7 days prior to the first dose of study treatment.\" \n- \"Participant is ineligible if any of the following hepatic characteristics are present: a) Alanine aminotransferase (ALT) >2.5×ULN b) ALT and/or aspartate aminotransferase (AST) >1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) >2.5×ULN c) Bilirubin >1×ULN d) Current active liver or biliary disease (with the exception of Gilbert’s syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease per the Investigator’s assessment) Note: Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\" \n- \"Participant has a corrected QT interval (QTc) >450 msec (or QTc >480 msec for participants with bundle branch block). Note the following: • The QTc is the QT interval corrected for heart rate according to Bazett’s formula (QTcB), Fridericia’s formula (QTcF), and/or another method, machine-read or manually over-read. • The specific formula that will be used to determine eligibility and discontinuation for an individual participant should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual participant, and then, the lowest QTc value used to include or discontinue the participant from the study. • For purposes of data analysis, QTcB, QTcF, another QT correction formula, or a composite of available values of QTc will be used as specified in the Statistical Analysis Plan (SAP).\""}

Endpoints

Primary endpoints

  • {"endpoint_text":"- \" Efficacy of triplet compared to docetaxel alone-OS defined as survival from the date of randomization to the date of death by any cause. \"","definition_or_measurement_approach":"OS defined as survival from the date of randomization to the date of death by any cause."}
  • {"endpoint_text":"- \" Efficacy of doublet compared to docetaxel alone-OS defined as survival from the date of randomization to the date of death by any cause. \"","definition_or_measurement_approach":"OS defined as survival from the date of randomization to the date of death by any cause."}

Secondary endpoints

  • {"endpoint_text":"- \"Efficacy of the triplet relative to the doublet-OS defined as survival from the date of randomization to the date of death by any cause. \"","definition_or_measurement_approach":"OS defined as survival from date of randomization to date of death by any cause."}
  • {"endpoint_text":"- \"The study will compare Arm A vs Arm C, Arm B vs Arm C and Arm A vs. Arm B using the following endpoints: - Confirmed ORR -PFS -DOR -TTD -Change from baseline as assessed by the EORTC-QLQ-C30 and the EORTC-QLQ-LC13 domains \"","definition_or_measurement_approach":"Endpoints include Confirmed ORR (objective response rate), PFS (progression-free survival), DOR (duration of response), TTD (time to deterioration), and change from baseline in domains of EORTC-QLQ-C30 and EORTC-QLQ-LC13. Specific measurement definitions not provided in the JSON."}
  • {"endpoint_text":"- \"The study will evaluate the safety and tolerability of Arm A and Arm B vs docetaxel alone using the following endpoints: - The incidence of TEAEs, SAEs, irAEs, TEAEs leading to death, and AEs leading to discontinuation occurring while participants are on treatment or up to 90 days after the last dose of study treatment.\"","definition_or_measurement_approach":"Safety endpoints: incidence of TEAEs, SAEs, immune-related AEs, TEAEs leading to death, and AEs leading to discontinuation; timeframe: while on treatment or up to 90 days after last dose."}

Recruitment

Planned Sample Size
320
Recruitment Window Months
73
Consent Approach
Written informed consent required from each participant as described in APPENDIX 5; participants must be ≥18 years old (≥19 years in Korea). Consent documentation includes multiple country- and language-specific ICFs (available English, French, German, Italian, Dutch, Polish, Spanish, Romanian, Swedish, Greek and other local versions) and specific ICF addenda (eg genetic consent, pregnant partner, continuation/rechallenge/restart forms). Signature pages and consent procedure documents are provided.

Methods

  • Recruitment and Informed Consent Procedure documents (multiple country-specific versions) — site-based recruitment and informed consent (documented).
  • Advertising procedures (e.g. 'Advertising procedures_Docrates_Redacted') — use of advertising materials for patient recruitment (flyers, infographics).
  • HCP referral materials — 'Recruitment_HCP Referral Tearsheet' and 'Recruitment_HCP Referral Email' indicate recruitment via healthcare professional referrals.
  • Patient-facing materials — trial infographics, patient flyers and translated informed consent forms in multiple languages to support patient recruitment.

Geography

Total Number Of Sites
69
Total Number Of Participants
440

Sweden

Earliest CTIS Part Ii Submission Date
07-02-2024
Latest Decision Or Authorization Date
22-02-2024
Processing Time Days
15
Number Of Sites
2
Number Of Participants
14

Sites

Site Name
Karolinska University Hospital
Department Name
Patientområde Huvud och hals lung och hudcancer Tema Cancer
Contact Person Name
Simon Ekman
Site Name
Region Gaevleborg
Department Name
Lungenheten Gävle sjukhus
Contact Person Name
Johan Isaksson

Belgium

Latest Decision Or Authorization Date
03-04-2024
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Pulmonology
Contact Person Name
Sofie Derijcke
Contact Person Email
longziekten@azgroeninge.be
Site Name
Onze-Lieve-Vrouwziekenhuis
Department Name
Department of pulmonary medicine
Contact Person Name
Piet Vercauter
Site Name
Jessa Ziekenhuis
Department Name
Dept of Pulmonology and Thoracic Oncology
Contact Person Name
Kristof Cuppens
Contact Person Email
kristof.cuppens@jessazh.be

Finland

Latest Decision Or Authorization Date
22-02-2024
Number Of Sites
1
Number Of Participants
8

Sites

Site Name
Pohjois-Savon hyvinvointialue
Department Name
KYS Syövänhoitokeskus
Contact Person Name
Okko Kääriäinen
Contact Person Email
kirjaamo@pshyvinvointialue.fi

Greece

Latest Decision Or Authorization Date
08-04-2024
Number Of Sites
11
Number Of Participants
33

Sites

Site Name
Henry Dunant Hospital Center
Department Name
4th Oncology Department & Clinical Trials Unit
Principal Investigator Name
Ioannis Mountzios
Principal Investigator Email
gmountzios@gmail.com
Contact Person Name
Ioannis Mountzios
Contact Person Email
gmountzios@gmail.com
Site Name
University General Hospital Attikon
Department Name
Internal Medicine Clinic, Oncology Unit
Principal Investigator Name
Amanda Psyrri
Principal Investigator Email
Psyrri237@yahoo.com
Contact Person Name
Amanda Psyrri
Contact Person Email
Psyrri237@yahoo.com
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
3rd Department of Internal Medicine
Principal Investigator Name
Konstantinos Syrigos
Principal Investigator Email
Ksyrigos.trials@gmail.com
Contact Person Name
Konstantinos Syrigos
Contact Person Email
Ksyrigos.trials@gmail.com
Site Name
Alexandra Hospital
Department Name
Oncology Unit, Department of Clinical Therapeutics
Principal Investigator Name
Flora Zagouri
Principal Investigator Email
florazagouri@yahoo.co.uk
Contact Person Name
Flora Zagouri
Contact Person Email
florazagouri@yahoo.co.uk
Site Name
General University Hospital Of Patras
Department Name
Department of Medicine, Medical Oncology
Principal Investigator Name
Angelos Koutras
Principal Investigator Email
angkoutr@otenet.gr
Contact Person Name
Angelos Koutras
Contact Person Email
angkoutr@otenet.gr
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Pulmonology Clinic
Principal Investigator Name
Dionysios Spyratos
Principal Investigator Email
diospyrato@yahoo.gr
Contact Person Name
Dionysios Spyratos
Contact Person Email
diospyrato@yahoo.gr
Site Name
Athens Medical Center S.A.
Department Name
Oncology Department
Principal Investigator Name
Sofia Baka
Principal Investigator Email
bakasofia@hotmail.com
Contact Person Name
Sofia Baka
Contact Person Email
bakasofia@hotmail.com
Site Name
University General Hospital Attikon
Department Name
Fourth Department of Internal Medicine
Principal Investigator Name
Anna Koumarianou
Principal Investigator Email
akoumari@yahoo.com
Contact Person Name
Anna Koumarianou
Contact Person Email
akoumari@yahoo.com
Site Name
General University Hospital Of Larissa
Department Name
Department of Chemotherapy , Ground floor
Principal Investigator Name
Athanasios Kotsakis
Principal Investigator Email
thankotsakis@hotmail.com
Contact Person Name
Athanasios Kotsakis
Contact Person Email
thankotsakis@hotmail.com
Site Name
St. Luke's Hospital S.A.
Department Name
Oncology Clinic
Principal Investigator Name
Eleni Fountzila
Principal Investigator Email
elenafou@gmail.com
Contact Person Name
Eleni Fountzila
Contact Person Email
elenafou@gmail.com
Site Name
General University Hospital Of Patras (additional listing)
Department Name
Oncology Unit
Contact Person Name
Delvys Rodríguez Abreu
Contact Person Email
drodabr@gobiernodecanarias.org

Poland

Latest Decision Or Authorization Date
15-03-2024
Number Of Sites
7
Number Of Participants
30

Sites

Site Name
Med Polonia Sp. z o.o.
Contact Person Name
Rodryg Ramlau
Site Name
Ars Medical Sp. z o.o.
Contact Person Name
Renata Surma-Włodarczyk
Contact Person Email
arsmedical.bk@farmepo.com
Site Name
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Contact Person Name
Małgorzata Ułańska
Contact Person Email
m.ulanska@ctw.com.pl
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Contact Person Name
Bogdan Żurawski
Contact Person Email
zurawskib@co.bydgoszcz.pl
Site Name
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Contact Person Name
Jarosław Kołb-Sielecki
Contact Person Email
jkolb@pulmonologia.olsztyn.pl
Site Name
Szpitale Pomorskie Sp. z o.o.
Contact Person Name
Joanna Pikiel
Site Name
Centrum Terapii Wspolczesnej / other listed site

Spain

Latest Decision Or Authorization Date
21-02-2024
Number Of Sites
15
Number Of Participants
80

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Oncología
Principal Investigator Name
Noemi Reguart Aransay
Principal Investigator Email
nreguart@clinic.cat
Contact Person Name
Noemi Reguart Aransay
Contact Person Email
nreguart@clinic.cat
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncología
Principal Investigator Name
Gema García Ledo
Principal Investigator Email
gmgarcialedo@hmhospitales.com
Contact Person Name
Gema García Ledo
Contact Person Email
gmgarcialedo@hmhospitales.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncología
Principal Investigator Name
Enriqueta Felip Font
Principal Investigator Email
enriqueta.felip@vallhebron.cat
Contact Person Name
Enriqueta Felip Font
Contact Person Email
enriqueta.felip@vallhebron.cat
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncología
Principal Investigator Name
Pilar Garrido López
Principal Investigator Email
pgarrido@salud.madrid.org
Contact Person Name
Pilar Garrido López
Contact Person Email
pgarrido@salud.madrid.org
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
Oncología
Principal Investigator Name
Delvys Rodríguez Abreu
Principal Investigator Email
drodabr@gobiernodecanarias.org
Contact Person Name
Delvys Rodríguez Abreu
Contact Person Email
drodabr@gobiernodecanarias.org
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncología
Principal Investigator Name
Manuel Cobo Dols
Principal Investigator Email
manuelcobodols@yahoo.es
Contact Person Name
Manuel Cobo Dols
Contact Person Email
manuelcobodols@yahoo.es
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncología
Principal Investigator Name
Rosario García Campelo
Principal Investigator Email
Ma.rosario.garcia.campelo@sergas.es
Contact Person Name
Rosario García Campelo
Site Name
Hospital Universitario La Paz
Department Name
Oncología
Principal Investigator Name
Francisco Javier de Castro Carpeño
Principal Investigator Email
javier.decastro@salud.madrid.org
Contact Person Name
Francisco Javier de Castro Carpeño
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Oncología
Principal Investigator Name
Mariano Provencio Pulla
Principal Investigator Email
mprovenciop@gmail.com
Contact Person Name
Mariano Provencio Pulla
Contact Person Email
mprovenciop@gmail.com
Site Name
Hospital Universitario Reina Sofia
Department Name
Oncología
Principal Investigator Name
Isidoro Carlos Barneto Aranda
Principal Investigator Email
isidoroc.barneto.sspa@juntadeandalucia.es
Contact Person Name
Isidoro Carlos Barneto Aranda
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncología
Principal Investigator Name
Luis Paz-Ares Rodríguez
Principal Investigator Email
lpazaresr@seom.org
Contact Person Name
Luis Paz-Ares Rodríguez
Contact Person Email
lpazaresr@seom.org
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncología
Principal Investigator Name
Rosa Álvarez Álvarez
Principal Investigator Email
ralvareza@salud.madrid.org
Contact Person Name
Rosa Álvarez Álvarez
Contact Person Email
ralvareza@salud.madrid.org
Site Name
Hospital Universitario De Burgos
Department Name
Oncología
Principal Investigator Name
Cristina Bayona Antón
Principal Investigator Email
cbayona@saludcastillayleon.es
Contact Person Name
Cristina Bayona Antón
Contact Person Email
cbayona@saludcastillayleon.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncología
Principal Investigator Name
Oscar Juan Vidal
Principal Investigator Email
juan_osc@gva.es
Contact Person Name
Oscar Juan Vidal
Contact Person Email
juan_osc@gva.es
Site Name
Institut Catala D'oncologia
Department Name
Oncología
Principal Investigator Name
Enric Carcereny Costa
Principal Investigator Email
ecarcereny@iconcologia.net
Contact Person Name
Enric Carcereny Costa
Contact Person Email
ecarcereny@iconcologia.net

Germany

Latest Decision Or Authorization Date
26-02-2024
Number Of Sites
2
Number Of Participants
66

Sites

Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik V - Thorakale Onkologie
Principal Investigator Name
Amanda Tufman
Principal Investigator Email
amanda.tufman@med.uni-muenchen.de
Contact Person Name
Amanda Tufman
Site Name
Krankenhaus Nordwest GmbH
Department Name
Institut für Klinisch-Onkologische Forschung (IKF)
Principal Investigator Name
Thorsten Oliver Götze
Principal Investigator Email
goetze.thorsten@khnw.de
Contact Person Name
Thorsten Oliver Götze
Contact Person Email
goetze.thorsten@khnw.de

Romania

Latest Decision Or Authorization Date
26-02-2024
Number Of Sites
5
Number Of Participants
49

Sites

Site Name
Oncolab S.R.L.
Department Name
Oncologie Medicala
Principal Investigator Name
Dan Lungulescu
Principal Investigator Email
dan.lungulescu@yahoo.com
Contact Person Name
Dan Lungulescu
Contact Person Email
dan.lungulescu@yahoo.com
Site Name
Memorial Healthcare International S.R.L.
Department Name
Oncology
Principal Investigator Name
Ingrid Iordan
Principal Investigator Email
mireliordan@yahoo.com
Contact Person Name
Ingrid Iordan
Contact Person Email
mireliordan@yahoo.com
Site Name
Radiology Therapeutic Center S.R.L.
Department Name
Oncologie Clinica
Principal Investigator Name
Elena Ciubotaru
Principal Investigator Email
elena.ciubotaru@amethyst-radiotherapy.com
Contact Person Name
Elena Ciubotaru
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Oncologie Medicala
Principal Investigator Name
Michael Schenker
Principal Investigator Email
mike_schenker@yahoo.com
Contact Person Name
Michael Schenker
Contact Person Email
mike_schenker@yahoo.com
Site Name
Oncomed S.R.L.
Department Name
Medical Oncology
Principal Investigator Name
Serban Negru
Principal Investigator Email
snegru@yahoo.com
Contact Person Name
Serban Negru
Contact Person Email
snegru@yahoo.com

Netherlands

Latest Decision Or Authorization Date
22-02-2024
Number Of Sites
5
Number Of Participants
23

Sites

Site Name
Medisch Spectrum Twente
Department Name
Longgeneeskunde
Principal Investigator Name
Emanuel Citgez
Principal Investigator Email
Onderzoeksbureau.longgeneeskunde@mst.nl
Contact Person Name
Emanuel Citgez
Site Name
Universitair Medisch Centrum Groningen
Department Name
Afdeling Longziekten
Principal Investigator Name
Thijo Hiltermann
Principal Investigator Email
trialbureau.longoncologie@long.umcg.nl
Contact Person Name
Thijo Hiltermann
Site Name
Ziekenhuis St Jansdal
Department Name
Poli Longgeneeskunde
Principal Investigator Name
Lisenka Boom
Principal Investigator Email
LN.Boom@stjansdal.nl
Contact Person Name
Lisenka Boom
Contact Person Email
LN.Boom@stjansdal.nl
Site Name
Isala Klinieken Stichting
Department Name
Poli Longgeneeskunde
Principal Investigator Name
Peter Plomp
Principal Investigator Email
p.m.j.plomp@isala.nl
Contact Person Name
Peter Plomp
Contact Person Email
p.m.j.plomp@isala.nl
Site Name
Stichting Radboud University Medical Center
Department Name
Pulmonary Medicine
Principal Investigator Name
Michel van den Heuvel
Principal Investigator Email
Researchunit.long@radboudumc.nl
Contact Person Name
Michel van den Heuvel

Italy

Latest Decision Or Authorization Date
23-02-2024
Number Of Sites
11
Number Of Participants
70

Sites

Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
SSD Oncologia Polmonare
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
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Dipartimento di Oncologia Medica 1
Principal Investigator Name
Giuseppe Lorusso
Principal Investigator Email
giuseppe.lorusso@istitutotumori.mi.it
Contact Person Name
Giuseppe Lorusso
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Clinica Oncologica
Principal Investigator Name
Rossana Berardi
Principal Investigator Email
rossana.berardi@ospedaliriuniti.marche.it
Contact Person Name
Rossana Berardi
Site Name
Hospital Santa Maria Della Misericordia
Department Name
S.C. Clinica Pediatrica
Principal Investigator Name
Elisa Minenza
Principal Investigator Email
elisa.minenza@ospedale.perugia.it
Contact Person Name
Elisa Minenza
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Dipartimento di Oncologia Medica
Principal Investigator Name
Alessandra Bulotta
Principal Investigator Email
bulotta.alessandra@hsr.it
Contact Person Name
Alessandra Bulotta
Contact Person Email
bulotta.alessandra@hsr.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
U.O. Oncologia Medica
Principal Investigator Name
Diego Cortinovis
Principal Investigator Email
diegoluigi.cortinovis@irccs-sangerardo.it
Contact Person Name
Diego Cortinovis
Site Name
Azienda Ospedaliera Universitaria Senese
Department Name
U.O.C. Immunoterapia Oncologica
Principal Investigator Name
Michele Maio
Principal Investigator Email
mmaiocro@gmail.com
Contact Person Name
Michele Maio
Contact Person Email
mmaiocro@gmail.com
Site Name
AORN San Giuseppe Moscati Avellino
Department Name
U.O. di Oncologia Medica
Principal Investigator Name
Cesare Gridelli
Principal Investigator Email
cgridelli@libero.it
Contact Person Name
Cesare Gridelli
Contact Person Email
cgridelli@libero.it
Site Name
Careggi University Hospital
Department Name
S.O.D. Radioterapia
Principal Investigator Name
Lorenzo Livi
Principal Investigator Email
lorenzo.livi@unifi.it
Contact Person Name
Lorenzo Livi
Contact Person Email
lorenzo.livi@unifi.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Struttura Complessa di Oncologia Medica Toraco-Polmonare
Principal Investigator Name
Alessandro Morabito
Principal Investigator Email
a.morabito@istitutotumori.na.it
Contact Person Name
Alessandro Morabito
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga (additional listing)
Department Name
SSD Oncologia Polmonare

France

Latest Decision Or Authorization Date
22-02-2024
Number Of Sites
7
Number Of Participants
56

Sites

Site Name
Institut Paoli-Calmettes
Department Name
Departement d'Oncologie Medicale
Principal Investigator Name
Philippe ROCHIGNEUX
Principal Investigator Email
rochigneuxp@ipc.unicancer.fr
Contact Person Name
Philippe ROCHIGNEUX
Contact Person Email
rochigneuxp@ipc.unicancer.fr
Site Name
Centre Hospitalier Intercommunal De Cornouaille
Department Name
Hopital Laennec - Departement d’Oncologie et Pneumologie
Principal Investigator Name
Romain CORRE
Principal Investigator Email
romain.corre@ch-cornouaille.fr
Contact Person Name
Romain CORRE
Contact Person Email
romain.corre@ch-cornouaille.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Hopital Pontchaillou - Service de Pneumologie
Principal Investigator Name
Herve LENA
Principal Investigator Email
herve.lena@chu-rennes.fr
Contact Person Name
Herve LENA
Contact Person Email
herve.lena@chu-rennes.fr
Site Name
Centre Hospitalier Intercommunal Creteil
Department Name
Service de Pneumologie
Principal Investigator Name
Christos CHOUAID
Principal Investigator Email
christos.chouaid@chicreteil.fr
Contact Person Name
Christos CHOUAID
Contact Person Email
christos.chouaid@chicreteil.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Hopital Bretonneau - Service de Pneumologie
Principal Investigator Name
Delphine CARMIER
Principal Investigator Email
d.carmier@chu-tours.fr
Contact Person Name
Delphine CARMIER
Contact Person Email
d.carmier@chu-tours.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Hopital Michallon - Service d’Oncologie Thoracique - SHUPP
Principal Investigator Name
Denis MORO-SIBILOT
Principal Investigator Email
dmoro-sibilot@chu-grenoble.fr
Contact Person Name
Denis MORO-SIBILOT
Contact Person Email
dmoro-sibilot@chu-grenoble.fr
Site Name
Centre Antoine Lacassagne
Department Name
Departement d'Oncologie Medicale
Principal Investigator Name
Clarisse AUDIGIER VALETTE
Contact Person Name
Clarisse AUDIGIER VALETTE

Sponsor

Primary sponsor

Full Name
Glaxosmithkline Research & Development Limited
Organisation Type
Pharmaceutical company
Country Of Registered Address
United Kingdom

Contract research organisations

Name
PPD Global Limited
Responsibilities
On site monitoring
Name
Pharmaceutical Product Development LLC
Responsibilities
manage benchmarking for all countries / site-level responsibilities
Name
Sermes CRO
Responsibilities
patient fee reimbursement
Name
IQVIA Rds Inc.
Responsibilities
data/operational responsibilities (listed as 'Chemical origin' in sponsor duties)

Third parties

  • {"country":"United States","full_name":"Corevitas LLC","duties_or_roles":"Patient survey","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Modern Diagnostic Imaging Methods A.E.","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Poland","full_name":"Let Me Pay Sp. z o.o.","duties_or_roles":"Patient fee reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"Medicine product destruction","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"University Of Wisconsin","duties_or_roles":"10","organisation_type":"Educational Institution"}
  • {"country":"Poland","full_name":"Komtur Polska Sp. z o.o.","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Clinops Tomasz Lusawa","duties_or_roles":"Renting equipment/medical devices to GSK for clinical sites","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Chemical origin","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translations","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"FACIT.Org Inc.","duties_or_roles":"licensing of ePRO's","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"PPD Global Limited","duties_or_roles":"On site monitoring","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"Chemical origin","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Idiotiko Diagnostiko Ergastirio Iatriki A.E.","duties_or_roles":"13, 4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Greece","full_name":"Affidea Piraeus Biopathological","duties_or_roles":"4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Greece","full_name":"Raptis Lab","duties_or_roles":"13, 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"IL-CSM Clinical Supplies Management GmbH","duties_or_roles":"Destruction of unused IP","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"ZALARIS Deutschland GmbH","duties_or_roles":"patient fee reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Roylance Stability Storage Limited","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Charles River Laboratories Inc.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Sermes CRO","duties_or_roles":"patient fee reimbursement","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Bioiatriki Private Medical Polyclinic S.A.","duties_or_roles":"13, 4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Greece","full_name":"Affidea Thessaloniki Private Polyclinic Iatriki Monoprosopi S.A.","duties_or_roles":"4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Omnitrace Corp.","duties_or_roles":"Overall survival support","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"long term storage of lab samples","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC (PPD)","duties_or_roles":"manage benchmarking for all countries / other listed responsibilities","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Chemical origin","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Greece","full_name":"Affidea Kifissia","duties_or_roles":"4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Greece","full_name":"KARYO Idiotiko Diagnostiko Ergastirio E.P.E.","duties_or_roles":"13, 4","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
JEMPERLI 500 mg concentrate for solution for infusion
Active Substance
DOSTARLIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Marketing authorisation referenced (EU/1/21/1538/001)
Maximum Dose
500 mg
Investigational Product Name
COBOLIMAB (solution for infusion)
Active Substance
COBOLIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous use
Authorisation Status
No marketing authorisation indicated in product dictionary entry
Maximum Dose
300 mg
Investigational Product Name
Docetaxel Hikma (various strengths) concentrate for solution for infusion
Active Substance
DOCETAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous use
Authorisation Status
Marketing authorisation referenced (national codes present, e.g. 93832.00.00 in DE)
Maximum Dose
75 mg/m2
Combination Treatment
Yes

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