A Study of JNJ-86974680 in Participants With Advanced Non-small Cell Lung Cancer

Johnson & Johnson (J&J)

Status and phase: Enrolling; Phase 1

Conditions: Carcinoma, Non-small-Cell Lung

Treatments: Radiation: Radiation Therapy; Drug: Cetrelimab; Drug: JNJ-86974680

Study type: Interventional

Funder types: Industry

Identifiers

NCT06116786

2023-506393-12-00 (Registry Identifier)

86974680NSC1001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Part 1: JNJ-86974680+Cetrelimab

Experimental group

Description:

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.

Treatment:

Drug: JNJ-86974680

Drug: Cetrelimab

Part 2: JNJ-86974680+Cetrelimab+Radiation Therapy (RT)

Experimental group

Description:

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.

Treatment:

Drug: JNJ-86974680

Drug: Cetrelimab

Radiation: Radiation Therapy