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

Carcinoma, Non-small-Cell Lung Clinical Trial

Official title:

A Phase 1 Study of JNJ-86974680, an A2a Receptor Antagonist, Administered as Monotherapy and in Combination With Cetrelimab and Radiotherapy for Advanced Non-small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06116786
• Other study ID #: 86974680NSC1001
• Secondary ID: 2023-504818-29-0
• Status: Recruiting
• Phase: Phase 1
• Start date: November 27, 2023
• Est. completion date: July 27, 2028

Study information

• Verified date: June 2024
• Source: Johnson & Johnson Enterprise Innovation Inc.
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: July 27, 2028
• Est. primary completion date: April 14, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-small-Cell Lung

Intervention

Drug:
• JNJ-86974680
JNJ-86974680 will be administered.
• Cetrelimab
Cetrelimab will be administered.

Radiation:
• Radiation Therapy
Radiation therapy will be administered.

Locations

Country	Name	City	State
Germany	Charite Research Organisation GmbH	Berlin
Germany	Universitaetsklinikum Giessen und Marburg GmbH	Giessen
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul
Spain	Hosp. Univ. Quiron Dexeus	Barcelona
Spain	Hosp. Univ. Vall D Hebron	Barcelona
United States	Roswell Park Comprehensive Cancer Center	Buffalo	New York
United States	Next Virginia	Fairfax	Virginia
United States	Herbert Irving Comprehensive Cancer Center Columbia University Medical Center	New York	New York
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Enterprise Innovation Inc.

Countries where clinical trial is conducted

United States,  Germany,  Korea, Republic of,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events (AEs) by Severity	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.	Up to 2 years 5 months
Primary	Number of Participants with Dose Limiting Toxicities (DLTs)	The DLTs are specific adverse events and are defined as any of the following: non-hematologic toxicity and hematological toxicity.	Up to 2 years 5 months
Secondary	Maximum Observed Plasma Concentration (Cmax) of JNJ-86974680	Cmax is defined as maximum observed plasma concentration of JNJ-86974680.	Up to 2 years 5 months
Secondary	Minimum Concentration (Cmin) of JNJ-86974680	Cmin is defined as the minimum observed plasma concentration of JNJ-86974680.	Up to 2 years 5 months
Secondary	Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-86974680	Tmax is defined the time to reach the maximum observed plasma concentration of JNJ-86974680.	Up to 2 years 5 months
Secondary	Terminal Elimination Half-life (t1/2) of JNJ-86974680	T1/2 is defined as terminal elimination half-life of JNJ-86974680.	Up to 2 years 5 months
Secondary	Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) of JNJ-86974680	(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).	Up to 2 years 5 months
Secondary	Area Under the Plasma Concentration-time Curve of JNJ-8697468 over the Dosing Interval (tau)	AUCtau is defined as the area under the plasma concentration-time curve of JNJ-8697468 over the dosing interval (tau).	Up to 2 years 5 months
Secondary	Apparent Clearance (CL/F) of JNJ-86974680	Apparent clearance of JNJ-86974680 was defined as a measure of the rate at which a drug got metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.	Up to 2 years 5 months
Secondary	Apparent Volume of Distribution (V/F) of JNJ-86974680	V/F was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of JNJ-86974680.	Up to 2 years 5 months
Secondary	Part 2: Overall Response Rate (ORR)	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.	Up to 2 years 5 months
Secondary	Part 2: Complete Response Rate (CRR)	CRR is defined as the proportion of participants with a best response of CR.	Up to 2 years 5 months
Secondary	Part 2: Duration of Response (DOR)	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.	Up to 2 years 5 months
Secondary	Part 2: Disease Control Rate (DCR)	DCR is defined as the percentage of participants who achieve a best of response of PR, CR, or stable disease using RECIST v1.1.	Up to 2 years 5 months