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Trial Title:
A Study of JNJ-86974680 in Participants With Advanced Non-small Cell Lung Cancer
NCT ID:
NCT06116786
Condition:
Carcinoma, Non-small-Cell Lung
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JNJ-86974680
Description:
JNJ-86974680 will be administered.
Arm group label:
Part 1: JNJ-86974680+Cetrelimab
Arm group label:
Part 2: JNJ-86974680+Cetrelimab+Radiation Therapy (RT)
Intervention type:
Drug
Intervention name:
Cetrelimab
Description:
Cetrelimab will be administered.
Arm group label:
Part 1: JNJ-86974680+Cetrelimab
Arm group label:
Part 2: JNJ-86974680+Cetrelimab+Radiation Therapy (RT)
Intervention type:
Radiation
Intervention name:
Radiation Therapy
Description:
Radiation therapy will be administered.
Arm group label:
Part 2: JNJ-86974680+Cetrelimab+Radiation Therapy (RT)
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Individuals with histologically or cytologically confirmed stage IIIB-IV non-small
cell lung cancer (NSCLC)
- 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
and have progressed. Individuals who cannot tolerate or have previously refused
platinum-based chemotherapy are eligible to enroll based on progression after
anti-PD-1/PD-L1 therapy alone
- Can have a prior or concurrent second malignancy (other than the disease under
study), which due to natural history or treatment is unlikely to interfere with any
study endpoints of safety or the efficacy of the study treatment(s)
- Have an eastern cooperative oncology group (ECOG) performance status of 0 or 1
- Adequate liver function:
1. Participants with no underlying hepatic metastases are eligible if they have:
i) aspartate aminotransferase (AST) less than (<)3 x upper limit of normal
(ULN), ii) alanine aminotransferase (ALT) <3 x ULN, and iii) Total bilirubin
<1.5 x ULN
2. Participants with known hepatic metastases are eligible if they have: i) AST <5
x ULN, ii) ALT <5 x ULN, and iii) Total bilirubin <3 x ULN
- 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. Participants with unknown
mutation status due to a failed testing status or lack of access to testing are
allowed in the study
- Part 2: Participants must have at least 3 lesions on baseline scan, one of which is
evaluable as a target lesion for response assessment per RECIST Version 1.1
- Part 2: Agree to submit tumor samples prior to study treatment which can be an
archival tumor tissue sample obtained within 3 months prior to start of treatment
and without any therapy for NSCLC being administered within these 3 months, or newly
obtained core or incisional biopsy of a tumor lesion during screening
Exclusion Criteria:
- Active disease involvement of the central nervous system with the exception of
definitively locally treated brain metastases that are clinically stable
- Active autoimmune disease that requires systemic immunosuppressive medications (for
example, chronic corticosteroid, methotrexate, or tacrolimus) within the 12 months
prior to signing consent
- Active infection or condition that requires treatment with systemic anti-infective
agents (for example, antibiotics, antifungal or antivirals) within 7 days prior to
the first dose of study treatment or chronic use of anti-infective agents
- History of solid organ or hematologic stem cell transplantation
- Part 2: NSCLC with an actionable genetic mutation for which an approved therapy is
available: EGFR, ALK, ROS1, or BRAF. Confirmation of the absence of actionable
mutations is required
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Roswell Park Comprehensive Cancer Center
Address:
City:
Buffalo
Zip:
14203
Country:
United States
Status:
Recruiting
Facility:
Name:
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Facility:
Name:
Thomas Jefferson University
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Facility:
Name:
Next Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Charite Research Organisation GmbH
Address:
City:
Berlin
Zip:
12203
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Giessen und Marburg GmbH
Address:
City:
Giessen
Zip:
35392
Country:
Germany
Status:
Recruiting
Facility:
Name:
Severance Hospital Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Hosp. Univ. Quiron Dexeus
Address:
City:
Barcelona
Zip:
08028
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp Univ Vall D Hebron
Address:
City:
Barcelona
Zip:
8035
Country:
Spain
Status:
Recruiting
Start date:
November 27, 2023
Completion date:
August 3, 2028
Lead sponsor:
Agency:
Johnson & Johnson Enterprise Innovation Inc.
Agency class:
Industry
Source:
Johnson & Johnson Enterprise Innovation Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06116786
