Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06116786 | A Study of JNJ-86974680 in Participants With Advanced Non-small Cell Lung Cancer | PHASE1 | RECRUITING | 126 | — | — | Nov 27, 2023 | Jun 7, 2029 | May 8, 2026 | 15 | United States, Germany +2 |
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.
The DLTs are specific adverse events and are defined as any of the following: non-hematologic toxicity and hematological toxicity.
| Arm | Type | Description |
|---|---|---|
| Part 1: JNJ-86974680+Cetrelimab | EXPERIMENTAL | 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) | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| JNJ-86974680 | DRUG | JNJ-86974680 will be administered. |
| Cetrelimab | DRUG | Cetrelimab will be administered. |
| Radiation Therapy | RADIATION | Radiation therapy will be administered. |
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 \[...