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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 (SELECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04549025
Recruitment Status : Active, not recruiting
First Posted : September 16, 2020
Last Update Posted : June 23, 2022
Sponsor:
Information provided by (Responsible Party):
Jounce Therapeutics, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
NSCLC Drug: JTX-4014 Drug: Vopratelimab Phase 2

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 19, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : March 2023

Arm Intervention/treatment
Experimental: JTX-4104
Drug: JTX-4014
Drug: JTX-4014
Specified dose on specified days

Experimental: JTX 4014 in combination with vopratelimab (dose level 1)

Drug: JTX-4014

Drug: Vopratelimab Other Name: JTX-2011

Drug: JTX-4014
Specified dose on specified days

Drug: Vopratelimab
Specified dose on specified days
Other Name: JTX-2011

Experimental: JTX 4014 in combination with vopratelimab (dose level 2)

Drug: JTX-4014

Drug: Vopratelimab Other Name: JTX-2011

Drug: JTX-4014
Specified dose on specified days

Drug: Vopratelimab
Specified dose on specified days
Other Name: JTX-2011




Primary Outcome Measures :
  1. Change in measurable lesion size [ Time Frame: averaged over 9 and 18 weeks ]
    Mean percent change from baseline in all measurable lesions


Secondary Outcome Measures :
  1. ORR [ Time Frame: up to 24 months ]
    ORR according to RECIST v1.1

  2. PFS [ Time Frame: up to 24 months ]
    PFS according to RECIST v1.1

  3. Landmark progression free survival (PFS) [ Time Frame: 9months ]
    Landmark progression free survival (PFS)

  4. Disease control rate (DCR) [ Time Frame: up to 24 months ]
    Disease control rate (DCR) according to RECIST v1.1

  5. Median duration of response (DOR) [ Time Frame: up to 24 months ]
    Median duration of response (DOR) according to RECIST v1.1

  6. Median overall survival (OS) [ Time Frame: up to 24 months ]
    Median overall survival (OS)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04549025


Locations
Show Show 68 study locations
Sponsors and Collaborators
Jounce Therapeutics, Inc.
Investigators
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Study Director: Ellen Hooper, MD Jounce Therapeutics, Inc.
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Responsible Party: Jounce Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04549025    
Other Study ID Numbers: JTX-4014-202
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: June 23, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases