Lung Cancer Clinical Trial

Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-Small Cell Lung Cancer Who Have Progressed on Prior Anti- Programmed Death-ligand 1 (PD-[L]1) Therapy and Chemotherapy

Summary

This is a multi-center, parallel group treatment, Phase 2 open label study evaluating cobolimab in combination with dostarlimab and docetaxel in participants with advanced Non-small cell Lung Cancer (NSCLC) who have progressed on prior anti-PD-(L)1 therapy and chemotherapy.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participant has histologically or cytologically proven advanced or metastatic NSCLC and only squamous or non-squamous cell carcinoma.
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 an anti-PD-(L)1 antibody.
Participant has measurable disease.
Participant has documented radiographic disease progression on prior platinum based chemotherapy and on or after prior anti-PD-(L)1 therapy.
Participant agrees to submit an archival formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen that was collected on or after diagnosis of metastatic disease. If archival tissue is not available, the participant must undergo biopsy prior to study entry.
Participant has an ECOG performance status score of 0 or 1.
Participant has a life expectancy of at least 3 months.
Participant has adequate Baseline organ function.
Participant has recovered from any prior treatment related toxicities.
Participant agrees to use contraception.

Exclusion Criteria:

Participant has been previously treated with an anti-PD-[L]1 or anti-programmed death-ligand 2 (anti-PD-[L]2) agent that resulted in permanent discontinuation due to an AE.
Participant has been previously treated with an anti-T cell immunoglobulin and mucin domain containing 3 (anti-TIM-3) or anti-cytotoxic T lymphocyte associated protein 4 (CTLA 4) agent or docetaxel.
Participant has a documented sensitizing epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or c-ros oncogene 1 (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.
Participant had radiological or clinical disease progression (i.e., worsening performance status, clinical symptoms, and laboratory data) <=8 weeks after initiation of prior anti-programmed cell death protein 1 (anti-PD-1) or anti-PD-L1 antibody. The clinical disease progression should have been confirmed by a subsequent radiological scan.
Participant has received radiation to the lung that is >30 gray (Gy) within 6 months prior to the first dose of study treatment.
Participant has completed palliative radiotherapy within 7 days prior to the first dose of study treatment.
Participant is ineligible if any of the following hepatic characteristics are present: a. Alanine aminotransferase (ALT) >2.5 times upper limit normal (ULN) b. ALT and/or aspartate aminotransferase (AST) >1.5 times ULN concomitant with alkaline phosphatase (ALP) >2.5 times ULN; c. Bilirubin >1 times 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).
Participant has known new or progressive brain metastases and/or leptomeningeal metastases. Participants who have received prior therapy for their brain metastases and have radiographically 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.
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 a ribonucleic acid (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.
Participant has known human immunodeficiency virus (HIV) (positive for HIV 1 or HIV 2 antibodies).
Participant has active autoimmune disease that required systemic treatment in the past 2 years, is immunocompromised in the opinion of the Investigator, or is receiving systemic immunosuppressive treatment.
Participant has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment of these conditions (including therapeutic thoracentesis or paracentesis) is eligible.
Participant has current interstitial lung disease, current pneumonitis, or a history of pneumonitis that required the use of glucocorticoids to assist with management.
Participant has pre-existing peripheral neuropathy that is Grade >=2 by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 criteria.
Participant has received a live vaccine within 30 days of the first dose of study treatment. Seasonal flu vaccines that do not contain live virus and Coronavirus Disease 2019 (COVID-19) vaccines.
Participant is unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) for undergoing a biopsy procedure (in cases when a participant does not have an archival biopsy), other than an aspirin dose <=1.3 grams (g) per day, for a 5-day period (8-day) period for long-acting agents, such as piroxicam).

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

750

Study ID:

NCT04655976

Recruitment Status:

Recruiting

Sponsor:

GlaxoSmithKline

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GSK Investigational Site
Fountain Valley California, 92708, United States More Info
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Eric Lee
Principal Investigator
GSK Investigational Site
Whittier California, 90603, United States More Info
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Paul La Porte
Principal Investigator
GSK Investigational Site
Norwich Connecticut, 06360, United States More Info
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Dinesh Kapur
Principal Investigator
GSK Investigational Site
Iowa City Iowa, 52242, United States More Info
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Muhammad Furqan
Principal Investigator
GSK Investigational Site
Edgewood Kentucky, 41017, United States More Info
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Goetz Kloecker
Principal Investigator
GSK Investigational Site
Las Vegas Nevada, 89144, United States More Info
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Brian Vicuna
Principal Investigator
GSK Investigational Site
Bronx New York, 10461, United States More Info
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Balazs Halmos
Principal Investigator
GSK Investigational Site
Mineola New York, 11501, United States More Info
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Vamsidhar Velcheti
Principal Investigator
GSK Investigational Site
New York New York, 10016, United States More Info
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Vamsidhar Velcheti
Principal Investigator
GSK Investigational Site
White Plains New York, 10601, United States More Info
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Daniel Sammartino
Principal Investigator
GSK Investigational Site
Pittsburgh Pennsylvania, 15224, United States More Info
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Mohammed F Islam
Principal Investigator
GSK Investigational Site
Pittsburgh Pennsylvania, 15232, United States More Info
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Liza Villaruz
Principal Investigator
GSK Investigational Site
Sioux Falls South Dakota, 57105, United States More Info
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Benjamin Solomon
Principal Investigator
GSK Investigational Site
Houston Texas, 77030, United States More Info
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Julio Peguero
Principal Investigator
GSK Investigational Site
Houston Texas, 77030, United States More Info
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Mehmet Altan
Principal Investigator
GSK Investigational Site
Pergamino Buenos Aires, B2700, Argentina More Info
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Susana Kahl
Principal Investigator
GSK Investigational Site
Viedma Río Negro, R8500, Argentina More Info
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Rubén Dario Kowalyszyn
Principal Investigator
GSK Investigational Site
Rosario Santa Fe, S2000, Argentina More Info
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Diego Abellan Von Farkas
Principal Investigator
GSK Investigational Site
Ciudad Autónoma de Buenos Aires , C1426, Argentina More Info
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Christian Sebastián Fuentes
Principal Investigator
GSK Investigational Site
La Rioja , F5300, Argentina More Info
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Diego Kaen
Principal Investigator
GSK Investigational Site
Blacktown New South Wales, 2148, Australia More Info
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Adnan Nagrial
Principal Investigator
GSK Investigational Site
Kurralta Park South Australia, 5037, Australia More Info
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Nimit Singhal
Principal Investigator
GSK Investigational Site
South Brisbane South Australia, 4101, Australia More Info
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Jermaine Ian George Coward
Principal Investigator
GSK Investigational Site
Hobart Tasmania, 7000, Australia More Info
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Rebecca Tay
Principal Investigator
GSK Investigational Site
Ballarat Victoria, 3350, Australia More Info
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Wasek Faisal
Principal Investigator
GSK Investigational Site
Melbourne Victoria, 3004, Australia More Info
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Maggie Moore
Principal Investigator
GSK Investigational Site
Fortaleza Ceará, 60336, Brazil More Info
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Eduardo Costa e Silva
Principal Investigator
GSK Investigational Site
Porto Alegre Rio Grande Do Sul, 90610, Brazil More Info
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Ana Caroline Zimmer Gelatti
Principal Investigator
GSK Investigational Site
Blumenau Santa Catarina, 89010, Brazil More Info
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Sandro L Reichow
Principal Investigator
GSK Investigational Site
São Paulo , 04014, Brazil More Info
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Lilian Barros
Principal Investigator
GSK Investigational Site
Kingston Ontario, K7L 5, Canada More Info
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Andrew Robinson
Principal Investigator
GSK Investigational Site
Oshawa Ontario, L1G 2, Canada More Info
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Jeffrey Rothenstein
Principal Investigator
GSK Investigational Site
Sudbury Ontario, P3E 5, Canada More Info
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Lacey Pitre
Principal Investigator
GSK Investigational Site
Greenfield Park Quebec, J4V 2, Canada More Info
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Giovanna Speranza
Principal Investigator
GSK Investigational Site
Montreal Quebec, H3T 1, Canada More Info
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Victor Cohen
Principal Investigator
GSK Investigational Site
Créteil Cedex , 94010, France More Info
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Christos Chouaid
Principal Investigator
GSK Investigational Site
Grenoble cedex 9 , 38043, France More Info
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Denis Moro-Sibilot
Principal Investigator
GSK Investigational Site
Marseille , 13009, France More Info
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Philippe Rochigneux
Principal Investigator
GSK Investigational Site
Nice Cedex 2 , 06189, France More Info
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Nicolas Martin
Principal Investigator
GSK Investigational Site
Quimper cedex , 29107, France More Info
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Romain Corre
Principal Investigator
GSK Investigational Site
Rennes Cedex 9 , 35033, France More Info
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Hervé Lena
Principal Investigator
GSK Investigational Site
Tours cedex 9 , 37044, France More Info
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Delphine Carmier
Principal Investigator
GSK Investigational Site
Karlsruhe Baden-Wuerttemberg, 76137, Germany More Info
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Christian Meyer zum Bueschenfelde
Principal Investigator
GSK Investigational Site
Muenchen Bayern, 80336, Germany More Info
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Amanda Tufman
Principal Investigator
GSK Investigational Site
Frankfurt am Main Hessen, 60590, Germany More Info
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Martin Sebastian
Principal Investigator
GSK Investigational Site
Frankfurt Hessen, 60488, Germany More Info
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Thorsten Oliver Goetze
Principal Investigator
GSK Investigational Site
Oldenburg Niedersachsen, 26121, Germany More Info
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Frank Griesinger
Principal Investigator
GSK Investigational Site
Bonn Nordrhein-Westfalen, 53113, Germany More Info
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Yon-Dschun Ko
Principal Investigator
GSK Investigational Site
Essen Nordrhein-Westfalen, 45147, Germany More Info
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Martin Metzenmacher
Principal Investigator
GSK Investigational Site
Koeln Nordrhein-Westfalen, 51109, Germany More Info
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Jessica Juergens
Principal Investigator
GSK Investigational Site
Halle Sachsen-Anhalt, 06120, Germany More Info
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Stephan Eisenmann
Principal Investigator
GSK Investigational Site
Dresden Sachsen, 01307, Germany More Info
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Martin Wermke
Principal Investigator
GSK Investigational Site
Leipzig Sachsen, 04103, Germany More Info
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Hubert Wirtz
Principal Investigator
GSK Investigational Site
Bad Berka Thueringen, 99437, Germany More Info
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Ekkehard Eigendorff
Principal Investigator
GSK Investigational Site
Gera Thueringen, 07548, Germany More Info
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Dagmar Taeuscher
Principal Investigator
GSK Investigational Site
Berlin , 12200, Germany More Info
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Sebastian Ochsenreither
Principal Investigator
GSK Investigational Site
Avellino Campania, 83100, Italy More Info
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Cesare Gridelli
Principal Investigator
GSK Investigational Site
Napoli Campania, 80131, Italy More Info
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Alessandro Morabito
Principal Investigator
GSK Investigational Site
Milano Lombardia, 20132, Italy More Info
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Vanesa Gregorc
Principal Investigator
GSK Investigational Site
Monza Lombardia, 20052, Italy More Info
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Diego Cortinovis
Principal Investigator
GSK Investigational Site
Torrette (AN) Marche, 60126, Italy More Info
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Rossana Berardi
Principal Investigator
GSK Investigational Site
Orbassano (TO) Piemonte, 10043, Italy More Info
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Silvia Novello
Principal Investigator
GSK Investigational Site
Firenze Toscana, 50134, Italy More Info
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Lorenzo Livi
Principal Investigator
GSK Investigational Site
Siena Toscana, 53100, Italy More Info
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Michele Maio
Principal Investigator
GSK Investigational Site
Cheongju-si, Chungcheongbuk-do , 28644, Korea, Republic of More Info
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Ki-Hyeong Lee
Principal Investigator
GSK Investigational Site
Gyeonggi-do , 10408, Korea, Republic of More Info
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Ji Youn Han
Principal Investigator
GSK Investigational Site
Seongnam-si, Gyeonggi-do , 13620, Korea, Republic of More Info
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Yu Jung kim
Principal Investigator
GSK Investigational Site
Seoul , 03722, Korea, Republic of More Info
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Hye Ryun Kim
Principal Investigator
GSK Investigational Site
Seoul , 05505, Korea, Republic of More Info
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Dae-Ho Lee
Principal Investigator
GSK Investigational Site
Seoul , 06351, Korea, Republic of More Info
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Se-Hoon Lee
Principal Investigator
GSK Investigational Site
Cdmx Ciudad De Mexico, 14050, Mexico More Info
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Jeronimo Rafael Rodriguez-Cid
Principal Investigator
GSK Investigational Site
Mexico City Ciudad De Mexico, 06700, Mexico More Info
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Eleazar Omar Macedo-Perez
Principal Investigator
GSK Investigational Site
Mexico Ciudad De Mexico, 03100, Mexico More Info
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Jorge Arturo Alatorre-Alexander
Principal Investigator
GSK Investigational Site
Monterrey Nuevo León, 64460, Mexico More Info
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Victor Manuel Oyervides-Juarez
Principal Investigator
GSK Investigational Site
Puebla , 72560, Mexico More Info
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Contact
+44 (0) 20 8990 4466
[email protected]
Ivan Romarico Gonzalez-Espinoza
Principal Investigator
GSK Investigational Site
Amersfoort , 3813 , Netherlands More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Gerarda J.M. Herder
Principal Investigator
GSK Investigational Site
Bydgoszcz , 85-79, Poland More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Bogdan Zurawski
Principal Investigator
GSK Investigational Site
Gdynia , 81-51, Poland More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Joanna Pikiel
Principal Investigator
GSK Investigational Site
Olsztyn , 10-35, Poland More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Jaroslaw Kolb Sielecki
Principal Investigator
GSK Investigational Site
Ostroleka , 07-41, Poland More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Agnieszka Domurad
Principal Investigator
GSK Investigational Site
Pila , 64-92, Poland More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Renata Surma-Wlodarczyk
Principal Investigator
GSK Investigational Site
Poznan , 60-69, Poland More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Rodryg Ramlau
Principal Investigator
GSK Investigational Site
Bucuresti , 02138, Romania More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Ingrid Iordan
Principal Investigator
GSK Investigational Site
Cluj Napoca , 40001, Romania More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Calin Ioan Cainap
Principal Investigator
GSK Investigational Site
Craiova , 20034, Romania More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Michael Schenker
Principal Investigator
GSK Investigational Site
Craiova , 20038, Romania More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Nelly Cherciu
Principal Investigator
GSK Investigational Site
Otopeni , 07510, Romania More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Elena Ciubotaru
Principal Investigator
GSK Investigational Site
Timisoara , 30023, Romania More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Serban Mircea Negru
Principal Investigator
GSK Investigational Site
Chelyabinsk , 45404, Russian Federation More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Oleg A Gladkov
Principal Investigator
GSK Investigational Site
Moscow , 14342, Russian Federation More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Daniil Lvovich Stroyakovskiy
Principal Investigator
GSK Investigational Site
Pushkin , 19660, Russian Federation More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Konstantin D Penkov
Principal Investigator
GSK Investigational Site
Saint-Petersburg , 19702, Russian Federation More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Sergey V. Orlov
Principal Investigator
GSK Investigational Site
Barcelona , 08035, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Enriqueta Felip
Principal Investigator
GSK Investigational Site
Barcelona , 08036, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Noemí Reguart Aransay
Principal Investigator
GSK Investigational Site
La Coruña , 15006, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Rosario García Campelo
Principal Investigator
GSK Investigational Site
Las Palmas De Gran Canaria , 35016, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Delvys Rodríguez Abreu
Principal Investigator
GSK Investigational Site
Madrid , 28034, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Pilar Garrido López
Principal Investigator
GSK Investigational Site
Madrid , 28041, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Luis Paz Ares
Principal Investigator
GSK Investigational Site
Madrid , 28046, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Javier de Castro Carpeño
Principal Investigator
GSK Investigational Site
Madrid , 28050, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Gema García Ledo
Principal Investigator
GSK Investigational Site
Majadahonda (Madrid) , 28222, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Mariano Provencio Pulla
Principal Investigator
GSK Investigational Site
Gävle , SE-80, Sweden More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Johan Isaksson
Principal Investigator
GSK Investigational Site
Solna , SE-17, Sweden More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Simon Ekman
Principal Investigator
GSK Investigational Site
Edinburgh , EH4 2, United Kingdom More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Melanie Mackean
Principal Investigator
GSK Investigational Site
London , W1G 6, United Kingdom More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Martin Forster
Principal Investigator
GSK Investigational Site
Manchester , M20 4, United Kingdom More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Raffaele Califano
Principal Investigator
GSK Investigational Site
Whitchurch, Cardiff , CF14 , United Kingdom More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Paul Shaw
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

750

Study ID:

NCT04655976

Recruitment Status:

Recruiting

Sponsor:


GlaxoSmithKline

How clear is this clinincal trial information?

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