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

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jounce Therapeutics, Inc.

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