NSCLC Clinical Trial
— SELECTOfficial 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
Verified date | March 2024 |
Source | Jounce Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Jounce Therapeutics, Inc. |
Belarus, Bosnia and Herzegovina, Bulgaria, Croatia, Georgia, Hungary, Latvia, Moldova, Republic of, Romania, Russian Federation, Serbia, Slovakia, Turkey, Ukraine,
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 |
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