A Study of JNJ-86974680 in Participants With Advanced Non-small Cell Lung Cancer
- Conditions
- Carcinoma, Non-small-Cell Lung
- Interventions
- Registration Number
- NCT06116786
- Lead Sponsor
- Johnson & Johnson Enterprise Innovation Inc.
- Brief Summary
The purpose of this study is to determine a safe and tolerable dose(s) of JNJ-86974680 for further research in combination with cetrelimab and radiation therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 126
- Individuals with histologically or cytologically confirmed stage IIIB-IV non-small cell lung cancer (NSCLC)
- Part 1: NSCLC with a known actionable genetic mutation (for example, epidermal growth factor receptor [EGFR], anaplastic lymphoma kinase [ALK], c-ros oncogene 1 [ROS1], v-raf murine sarcoma viral oncogene homolog B1 [BRAF]) must have received all approved targeted therapies and have progressed
- Part 2: No targetable mutations (for example, EGFR [epidermal growth factor receptor], ALK [anaplastic lymphoma kinase], ROS1[c-ros oncogene 1], and BRAF [B-Raf proto-oncogene, serine/threonine kinase])
- Part 1 and Cohort A of part 2: Must have been treated with (a) anti-programmed death protein 1 (anti-PD-1) or programmed cell death ligand 1 (PD-L1) therapy and (b) platinum-based chemotherapy
- For Cohort B of Part 2: Previously treated with anti-PD-1/PD-L1 therapy for metastatic disease as the prior line of therapy
- For Cohort C of Part 2: Treatment naïve
- Adequate organ function
- Active central nervous system (CNS) disease involvement
- Active autoimmune disease
- Active infection
- History of solid organ or hematologic stem cell transplantation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: JNJ-86974680+Cetrelimab JNJ-86974680 Participants will receive JNJ-86974680 alone (dose 1, dose 2, dose 3, and dose 4) daily in 4 cohorts and then along with a set dose of cetrelimab. Part 1: JNJ-86974680+Cetrelimab Cetrelimab Participants will receive JNJ-86974680 alone (dose 1, dose 2, dose 3, and dose 4) daily in 4 cohorts and then along with a set dose of cetrelimab. Part 2: JNJ-86974680+Cetrelimab+Radiation Therapy (RT) JNJ-86974680 Part 2 will consist of 3 cohorts (A, B and C) and participants will receive treatment with the selected dose of JNJ-86974680 in combination with cetrelimab from part 1, in conjunction with radiation. Part 2: JNJ-86974680+Cetrelimab+Radiation Therapy (RT) Cetrelimab Part 2 will consist of 3 cohorts (A, B and C) and participants will receive treatment with the selected dose of JNJ-86974680 in combination with cetrelimab from part 1, in conjunction with radiation. Part 2: JNJ-86974680+Cetrelimab+Radiation Therapy (RT) Radiation Therapy Part 2 will consist of 3 cohorts (A, B and C) and participants will receive treatment with the selected dose of JNJ-86974680 in combination with cetrelimab from part 1, in conjunction with radiation.
- Primary Outcome Measures
Name Time Method Number of Participants with Dose Limiting Toxicities (DLTs) Up to 2 years 5 months The DLTs are specific adverse events and are defined as any of the following: non-hematologic toxicity and hematological toxicity.
Number of Participants with Adverse Events (AEs) by Severity Up to 2 years 5 months An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
- Secondary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) of JNJ-86974680 Up to 2 years 5 months Cmax is defined as maximum observed plasma concentration of JNJ-86974680.
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) of JNJ-86974680 Up to 2 years 5 months (AUC0-t) is defined as area under the plasma concentration of JNJ-86974680 versus time curve from the time of dose administration to time of last quantifiable concentration (0-t).
Part 2: Overall Response Rate (ORR) Up to 2 years 5 months ORR is defined as the percentage of participants who have a best response of complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version (v)1.1, maintained for at least 4 weeks.
Part 2: Complete Response Rate (CRR) Up to 2 years 5 months CRR is defined as the proportion of participants with a best response of CR.
Part 2: Duration of Response (DOR) Up to 2 years 5 months DoR is defined as the time from the date of first initial documentation of a response to the date of first documented evidence of progression of disease according to immunotherapy response evaluation criteria in solid tumors (iRECIST) or death due to any cause, whichever occurs first.
Part 2: Disease Control Rate (DCR) Up to 2 years 5 months DCR is defined as the percentage of participants who achieve a best of response of PR, CR, or stable disease using RECIST v1.1.
Trial Locations
- Locations (10)
Next Virginia
🇺🇸Fairfax, Virginia, United States
Charite Research Organisation GmbH
🇩🇪Berlin, Germany
Universitaetsklinikum Giessen und Marburg GmbH
🇩🇪Giessen, Germany
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Hosp. Univ. Quiron Dexeus
🇪🇸Barcelona, Spain
Hosp Univ Vall D Hebron
🇪🇸Barcelona, Spain
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
🇺🇸New York, New York, United States
Roswell Park Comprehensive Cancer Center
🇺🇸Buffalo, New York, United States
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States