Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen

NSCLC Clinical Trial

— SELECT  

Official title:

Phase 2 Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab, an ICOS Agonist, in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04549025
• Other study ID #: JTX-4014-202
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 19, 2020
• Est. completion date: May 2024

Study information

• Verified date: March 2024
• Source: Jounce Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 2, open-label study to evaluate PD-1 inhibitor JTX-4014 alone and in combination with vopratelimab, an ICOS agonist, in biomarker-selected adult subjects with metastatic NSCLC who are PD-1/PD-L1 inhibitor naïve and have progressed on a platinum based chemotherapy regimen.

Description:

JTX-4014 is a fully human IgG4 monoclonal antibody designed to specifically bind to PD-1 and block its interaction with its ligands, PD-L1 and PD-L2, to augment anti-tumor T cell activity. Vopratelimab is an agonist monoclonal antibody that specifically binds to the Inducible CO-Stimulator of T cells (ICOS) to generate an anti-tumor immune response. This is a Phase 2, open label study to evaluate the efficacy, safety, tolerability of JTX-4014 alone and in combination with vopratelimab in biomarker-selected adult subjects with metastatic NSCLC who are PD-1/PD-L1 inhibitor naïve and have progressed on a platinum based chemotherapy regimen

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 69
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able and willing to participate and comply with all study requirements
• Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) with evaluable or measurable disease according to RECIST v1.1 with at least 1 measurable lesion
• Confirmed tumor RNA signature score
• Experienced progression of locally advanced or metastatic NSCLC after 1 prior systemic antineoplastic platinum-containing regimen (adjuvant therapy will count as a regimen if administered within 1 year before the relapse)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Predicted life expectancy of = 3 months
• Adequate organ function
• WOCBP must agree to use highly effective birth control

Exclusion Criteria:

• Concurrent anticancer treatment or subject is expected to require any other form of antineoplastic therapy while on study, either approved or investigational.
• Current or past participation in a study of an investigational agent or using an investigational device in the metastatic setting
• Chemotherapy < 28 days prior to planned C1D1
• Prior immunotherapy including, but not limited to PD-1 or PD-L1 inhibitor mAb at any time, including JTX-4014; therapy with any mAb that specifically binds to ICOS, including vopratelimab; or chimeric antigen receptor T cell therapy
• Use of anticancer therapies listed below in the metastatic setting (allowed as prior

treatment for localized disease):

1. Biologic therapy

2. Targeted small molecule therapy

3. Organ transplantation, including allogeneic or autologous stem cell transplantation

• Positive test for any of the following epidermal growth factor receptor gene mutations in blood or tumor: Exon 18 G719A; Exon 18 G719C; Exon 18 G719S; Exon 19 Del; Exon 20 S768I; Exon 20 T790M; Exon 20 Ins; Exon 21 L858R; Exon 21 L861Q
• Prior whole brain radiation

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Intervention

Drug:
• JTX-4014
Specified dose on specified days
• Vopratelimab
Specified dose on specified days

Locations

Country	Name	City	State
Belarus	Minsk City Clinical Oncology Dispensary	Minsk
Belarus	N. N. Alexandrov National Cancer Centre	Minsk
Bosnia and Herzegovina	Klinicki centar Republike Srpske	Banja Luka
Bosnia and Herzegovina	Klinicki centar Univerziteta u Sarajevu	Sarajevo
Bulgaria	Multiprofile Hospital for Active Treatment - Dobrich AD	Dobrich
Bulgaria	Multiprofile Hospital for Active Treatment - Uni Hospital OOD	Panagyurishte
Bulgaria	Complex Oncology Center Plovdiv	Plovdiv
Bulgaria	Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda	Sofia
Bulgaria	Multiprofile Hospital for Active Treatment Serdika EOOD	Sofia
Croatia	Klinicki bolnicki centar Osijek	Osijek
Croatia	General Hospital Pula	Pula
Croatia	Klinicki bolnicki centar Split	Split
Croatia	Klinicki bolnicki centar Zagreb	Zagreb
Georgia	ARENSIA Exploratory Medicine LLC / Tbilisi, Georgia	Tbilisi
Hungary	Veszprem Megyei Tudogyogyintezet	Farkasgyepu
Hungary	Bács-Kiskun Megyei Kórház, SZTE ÁOK Oktató Kórháza	Kecskemét
Hungary	Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz	Székesfehérvár
Latvia	Pauls Stradins Clinical University Hospital	Riga
Latvia	Riga East Clinical University Hospital, Latvian Oncology Center	Riga
Moldova, Republic of	Institute of Oncology, ARENSIA Exploratory Medicine	Chisinau
Romania	Affidea Romania SRL	Bucharest
Romania	Prof Dr I Chiricuta Institute of Oncology	Cluj-Napoca
Romania	Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta	Constanta
Romania	Oncology Center Sfantul Nectarie	Craiova
Russian Federation	Arkhangelsk Regional Clinical Oncology Dispensary	Arkhangel'sk
Russian Federation	Chelyabinsk Regional Clinical Oncology Dispensary	Chelyabinsk
Russian Federation	Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic	Kazan
Russian Federation	Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy	Krasnoyarsk
Russian Federation	Kursk Regional Oncology Centre	Kursk
Russian Federation	Vitamed	Moscow
Russian Federation	Nizhniy Novgorod City Oncology Center	Nizhny Novgorod
Russian Federation	Clinical Oncology Dispensary	Omsk
Russian Federation	Evromedservis LCC	Pushkin
Russian Federation	Ryazan State Medical University n.a. I.P. Pavlov	Ryazan'
Russian Federation	First St. Petersburg State Medical University n.a. I.P Pavlov	Saint Petersburg
Russian Federation	GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)	Saint Petersburg
Russian Federation	JSC "Current medical technologies"	Saint Petersburg
Russian Federation	Mordovia State University	Saransk
Russian Federation	Research Oncology Institute of Tomsk Scientific Center	Tomsk
Russian Federation	Volgograd Regional Clinical Oncology Dispensary	Volgograd
Russian Federation	Regional Clinical Oncology Hospital	Yaroslavl
Serbia	Clinical Center of Serbia - PPDS	Belgrade
Serbia	Clinical Hospital Center Bezanijska Kosa	Belgrade
Serbia	Institute for Oncology and Radiology of Serbia - PPDS	Belgrade
Serbia	Clinical Center Kragujevac	Kragujevac
Serbia	Institute of Lung Diseases Vojvodina	Sremska Kamenica
Slovakia	Narodny onkologicky ustav	Bratislava
Slovakia	Vychodoslovensky onkologicky ustav, a.s.	Košice
Turkey	Adana Sehir Egitim ve Arastirma Hastanesi	Adana
Turkey	Hacettepe University Medical Faculty Hospital	Ankara	Sihhiye
Turkey	Akdeniz University Medical Faculty	Antalya
Turkey	Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi Hastane	Edirne
Turkey	Istanbul University Cerrahpasa Medical Faculty	Istanbul
Turkey	T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin City Hospital	Istanbul
Turkey	Ege Universitesi Tip Fakultesi Hastanesi	Izmir
Turkey	Izmir Medicalpark Hospital	Izmir
Turkey	Inonu University Faculty of Medicine Turgut Ozal Medical Center	Malatya
Ukraine	Communal Nonprofit Enterprise Cherkasy Regional On?ology Dispensary of Cherkasy Oblast Council	Cherkasy
Ukraine	Communal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council - PPDS	Dnipro
Ukraine	Municipal Non-profit Enterprise "SubCarpathian Clinical Oncological Centre of Ivano-Frankivsk RC"	Ivano-Frankivs'k
Ukraine	Arensia Kapitanivka - PPDS	Kapitanivka
Ukraine	Communal Non-profit Enterprise Regional Center of Oncology	Kharkiv
Ukraine	SI Institute of Medical Radiology and Oncology n.a. S.P. Hryhoriev of NAMS of Ukraine	Kharkiv
Ukraine	CNPE Khmelnytskyi Regional Antitumor Center of Khmelnytskyi Regional Council	Khmelnytskyi
Ukraine	Private Enterprise Private Manufacturing Company Acinus	Kropyvnytskyi
Ukraine	Communal Nonprofit Enterprise Kyiv City Clinical Oncological Center	Kyiv
Ukraine	Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway	Kyiv
Ukraine	Modern Cancer Care Hospital "LISOD"	Kyiv
Ukraine	National Institute of Cancer	Kyiv
Ukraine	The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council	Luts'k
Ukraine	MNPE Central City Clinical Hospital of Uzhhorod City Council	Uzhhorod

Sponsors (1)

Lead Sponsor	Collaborator
Jounce Therapeutics, Inc.

Countries where clinical trial is conducted

Belarus,  Bosnia and Herzegovina,  Bulgaria,  Croatia,  Georgia,  Hungary,  Latvia,  Moldova, Republic of,  Romania,  Russian Federation,  Serbia,  Slovakia,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in measurable lesion size	Mean percent change from baseline in all measurable lesions	averaged over 9 and 18 weeks
Secondary	ORR	ORR according to RECIST v1.1	up to 24 months
Secondary	PFS	PFS according to RECIST v1.1	up to 24 months
Secondary	Landmark progression free survival (PFS)	Landmark progression free survival (PFS)	9months
Secondary	Disease control rate (DCR)	Disease control rate (DCR) according to RECIST v1.1	up to 24 months
Secondary	Median duration of response (DOR)	Median duration of response (DOR) according to RECIST v1.1	up to 24 months
Secondary	Median overall survival (OS)	Median overall survival (OS)	up to 24 months