Approval Probability
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Adjusted LOA
ML Risk
JNJ-86974680 · 1 trial · 1 indication
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 \[...
JNJ-86974680 is an investigational small molecule being developed for the treatment of advanced non-small cell lung cancer (NSCLC). It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being evaluated for safety and efficacy in clinical trials.
JNJ-86974680 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is currently in Phase 1 clinical trials for the treatment of advanced non-small cell lung cancer.
JNJ-86974680 is in Phase 1 clinical development. It is an investigational drug being studied for the treatment of advanced non-small cell lung cancer. As a Phase 1 candidate, it is not yet approved by the FDA or any other regulatory agency and is still undergoing early-stage clinical evaluation.
JNJ-86974680 is being studied in a Phase 1 clinical trial with the identifier NCT06116786. This trial, titled "A Study of JNJ-86974680 in Participants With Advanced Non-small Cell Lung Cancer," is active but not recruiting participants. The study is enrolling 67 participants across the United States, Germany, South Korea, and Spain.
No, JNJ-86974680 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of advanced non-small cell lung cancer. The drug is still being studied in clinical trials to evaluate its safety and efficacy, and it has not yet received marketing approval from regulatory authorities.