Carcinoma, Non-small-Cell Lung
Conditions
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.
Interventions
DRUGJNJ-86974680
JNJ-86974680 will be administered.
DRUGCetrelimab
Cetrelimab will be administered.
RADIATIONRadiation Therapy
Radiation therapy will be administered.
Sponsors
Johnson & Johnson Enterprise Innovation Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Active central nervous system (CNS) disease involvement * Active autoimmune disease * Active infection * History of solid organ or hematologic stem cell transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany, South Korea, Spain, United States
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJohnson & Johnson Enterprise Innovation, Inc Clinical Trial
Johnson & Johnson Enterprise Innovation Inc.
Outcome results
None listed