Metastatic Non Small Cell Lung Cancer (NSCLC) MedDRA version: 21.1 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: JTX-4014
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not Available
CAS Number: 2293951-22-9
Current Sponsor code: JTX-4014
Concentration unit: mg/ml milligram(s)/mil
Sponsors
Jounce Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able and willing to participate and comply with all study requirements and provide signed and dated informed consent prior to initiation of any study procedures 2. Histologically or cytologically confirmed diagnosis of NSCLC with evaluable or measurable disease according to RECIST v1.1 with at least 1 measurable lesion 3. Confirmed tumor RNA signature score = 7.9 4. 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) 5. Age of = 18 years 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 7. Predicted life expectancy of = 3 months 8. The following laboratory values: a. Hemoglobin = 9.0 g/dL b. Platelet count = 75 × 109 cells/L c. Absolute neutrophil count > 1.5 × 109 and =65 years) yes F.1.3.1 Number of subjects for this age range 38
Exclusion criteria
Exclusion criteria: 1. Concurrent anticancer treatment or subject is expected to require any other form of antineoplastic therapy while on study, either approved or investigational 2. Current or past participation in a study of an investigational agent or using an investigational device in the metastatic setting 3. Chemotherapy 1 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Exceptions: Grade > 1 toxicities that, in the opinion of the Investigator, should not exclude the subject (e.g., alopecia, Grade 2 neuropathy, hypo- or hyperthyroidism, or other endocrinopathies that are well controlled with hormone replacement therapy) and are approved by the Medical Monitor b. History of pneumonitis or interstitial lung disease c. Symptomatic ascites or pleural effusion (subjects who are clinically stable for > 3 months following treatment for these conditions [including therapeutic thoraco- or paracentesis] are eligible) d. If with medical history of the following, eligibility should be discussed with the Medical Monitor: colitis, hepatitis, nephritis, skin reactions, or encephalitis. 8. Known severe intolerance or life-threatening hypersensitivity reactions to humanized mAbs or IV Ig preparations; any history of anaphylaxis; prior history of human anti-human antibody response; or known allergy to any of the study drugs (including their analogues or excipients [L-histidine, mannitol, sodium chloride, or polysorbate 80]) 9. Major surgery (excluding minor procedures, e.g., placement of vascular access, gastrointestinal/biliary stent, and biopsy) < 4 weeks prior to planned C1D1 10. Prior whole brain radiation 11. Subjects with the following should be reviewed with the Medical Monitor prior to enrollment: a. Brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation b. Radiation (other than whole brain radiation) has been or will be administered < 21 days prior to planned C1D1 12. Active and clinically relevant bacterial, fungal, or viral infection, including known hepatitis B, C, or human immunodeficiency virus (testing not required) 13. Receipt of live vaccines within 30 days of planned C1D1 (Inactivated vaccines are allowed; seasonal vaccines should be up-to-date prior to planned C1D1.) 14. Women who are pregnant, breastfeeding, or who plan to become pregnant/breastfeed while on study; men who plan to father children during the study 15. Concurrent second malignancy 16. An active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To demonstrate superiority of the combination of JTX-4014 with vopratelimab over JTX-4014 monotherapy in biomarker-selected subjects;Secondary Objective: •To evaluate efficacy as measured by ORR, PFS, landmark PFS at 9 months, disease control rate, duration of response, and OS • To evaluate the safety and tolerability of JTX-4014 alone and in combination with vopratelimab • To evaluate the PK of JTX-4014 and vopratelimab • To assess the immunogenicity of JTX-4014 and vopratelimab • To evaluate association of baseline tumor RNA signature score with clinical outcomes;Primary end point(s): • Mean percent change from baseline tumor size of all measurable existing and new lesions averaged over 9 and 18 weeks;Timepoint(s) of evaluation of this end point: Study assessments and procedures will be performed as outlined in the Protocol Appendix 1 (Schedule of Assessments and Sampling Time Points for Cohort MC1) and Appendix 2 (Schedule of Assessments and Sampling Time Points for Cohorts CC1 and CC2). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • ORR (percentage of subjects with CR + PR) according to RECIST, v1.1 • PFS according to RECIST, v1.1 • Landmark PFS rate at 9 months according to RECIST, v1.1 • Disease control rate (confirmed CR + confirmed PR + unconfirmed SD) according to RECIST, v1.1 • Duration of response in months according to RECIST, v1.1 • OS • Incidence and grade of treatment-emergent adverse events (TEAEs) • PK properties of JTX-4014 and vopratelimab • Incidence of ADAs to either JTX-4014 or vopratelimab • Incidence of neutralizing antibody (NAb) to either JTX-4014 or vopratelimab • Association of baseline tumor RNA signature score with clinical outcomes;Timepoint(s) of evaluation of this end point: Study assessments and procedures will be performed as outlined in the Protocol Appendix 1 (Schedule of Assessments and Sampling Time Points for Cohort MC1) and Appendix 2 (Schedule of Assessments and Sampling Time Points for Cohorts CC1 and CC2). | — |
Countries
Belarus, Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Georgia, Hungary, Latvia, Moldova, Republic of, Poland, Romania, Russian Federation, Serbia, Slovakia, Turkey, Ukraine
Contacts
Public ContactJounce Therapeutics
Jounce Therapeutics, Inc.
Outcome results
None listed