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Monoclonal Antibodies

JNJ-86974680 + Radiation Therapy + Cetrelimab for Non-Small Cell Lung Cancer

Q: What is the current capacity of this clinical trial?

Affirmative. Data available on clinicaltrials.gov suggests that this experiment has been accepting participants since November 20th, 2023 after the latest update was made on November 8th of the same year. Two medical sites are looking to recruit a total of seventy-six patients for this trial.

Q: Are there any open recruitment opportunities for this research endeavor?

According to the information on clinicaltrials.gov, this investigation is actively searching for participants and has been since it was first uploaded in November 20th of 2022. The data was last updated a month later, as recently as November 8th of 2022.

Q: Has the combination of JNJ-86974680 and Cetrelimab been granted authorization by the FDA?

Due to the infancy of Phase 1 trials, our team gave JNJ-86974680+Cetrelimab a score of one on the safety scale. This is based upon limited data indicating its efficacy and lack thereof for safety.

Q: What objectives have been identified for this clinical endeavor?

According to information reported by Johnson &#x26; Johnson Enterprise Innovation Inc., the primary outcome, which will be measured over a Up to 2 years 5 month duration, is the number of participants experiencing adverse events (AEs) sorted according to severity. Secondary outcomes such as apparent volume of distribution (V/F), complete response rate (CRR), and duration of response (DOR) will also be evaluated. V/F indicates theoretical drug concentration in plasma while CRR represents proportion of patients with best responses documented as 'complete response' and DOR denotes time between initial documentation of response until progression or death due to any cause.

Phase 1

Recruiting

Research Sponsored by Johnson & Johnson Enterprise Innovation Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals with histologically or cytologically confirmed stage IIIB-IV non-small cell lung cancer (NSCLC) who have been treated with anti-programmed death protein 1 (anti-PD-1) or programmed cell death ligand 1 (PD-L1) therapy and platinum-based chemotherapy and have progressed

Participants with adequate liver function: 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 if no underlying hepatic metastases; or i) AST <5 x ULN, ii) ALT <5 x ULN, and iii) Total bilirubin <3 x ULN if known hepatic metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years 5 months

Awards & highlights

Study Summary

This trial studies a new drug combo to see if it's safe & effective for cancer treatment.

Who is the study for?

This trial is for individuals with advanced non-small cell lung cancer who have already tried anti-PD-1/PD-L1 therapy and chemotherapy but their cancer has progressed. They must have good liver function, at least 3 lesions visible on scans, and be able to provide a recent tumor sample. People with active autoimmune diseases, organ transplants, untreated brain metastases or certain genetic mutations treatable by approved drugs cannot join.Check my eligibility

What is being tested?

The study is testing the safety and tolerability of JNJ-86974680 when combined with cetrelimab (another drug) and radiation therapy in patients. The goal is to find the right doses of JNJ-86974680 that can be used safely for further research.See study design

What are the potential side effects?

Potential side effects may include typical reactions related to immunotherapy such as fatigue, skin reactions, inflammation in various organs, flu-like symptoms, changes in blood tests affecting liver function or immune cells. Radiation could cause skin irritation or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have advanced lung cancer and my previous treatments with specific immune therapies and chemotherapy have not worked.

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My liver functions are within the required limits for the trial.

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My NSCLC has a specific mutation and I've tried all approved treatments without success.

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I am fully active or can carry out light work.

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I have at least 3 cancer lesions, with one measurable for treatment response.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years 5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years 5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years 5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Adverse Events (AEs) by Severity

Number of Participants with Dose Limiting Toxicities (DLTs)

Secondary outcome measures

Apparent Clearance (CL/F) of JNJ-86974680

Apparent Volume of Distribution (V/F) of JNJ-86974680

Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) of JNJ-86974680

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2: JNJ-86974680+Cetrelimab+Radiation Therapy (RT)Experimental Treatment3 Interventions

Participants will receive treatment with the identified safe dose of JNJ-86974680 in combination with cetrelimab from part 1, in conjunction with radiation.

Group II: Part 1: JNJ-86974680+CetrelimabExperimental Treatment2 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

Cetrelimab

2022

Completed Phase 1

~20

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johnson & Johnson Enterprise Innovation Inc.Lead Sponsor

2 Previous Clinical Trials

141 Total Patients Enrolled

Johnson & Johnson Enterprise Innovation, Inc Clinical TrialStudy DirectorJohnson & Johnson Enterprise Innovation Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current capacity of this clinical trial?

"Affirmative. Data available on clinicaltrials.gov suggests that this experiment has been accepting participants since November 20th, 2023 after the latest update was made on November 8th of the same year. Two medical sites are looking to recruit a total of seventy-six patients for this trial."

Answered by AI

Are there any open recruitment opportunities for this research endeavor?

"According to the information on clinicaltrials.gov, this investigation is actively searching for participants and has been since it was first uploaded in November 20th of 2022. The data was last updated a month later, as recently as November 8th of 2022."

Answered by AI

Has the combination of JNJ-86974680 and Cetrelimab been granted authorization by the FDA?

"Due to the infancy of Phase 1 trials, our team gave JNJ-86974680+Cetrelimab a score of one on the safety scale. This is based upon limited data indicating its efficacy and lack thereof for safety."

Answered by AI

What objectives have been identified for this clinical endeavor?

"According to information reported by Johnson & Johnson Enterprise Innovation Inc., the primary outcome, which will be measured over a Up to 2 years 5 month duration, is the number of participants experiencing adverse events (AEs) sorted according to severity. Secondary outcomes such as apparent volume of distribution (V/F), complete response rate (CRR), and duration of response (DOR) will also be evaluated. V/F indicates theoretical drug concentration in plasma while CRR represents proportion of patients with best responses documented as 'complete response' and DOR denotes time between initial documentation of response until progression or death due to any cause."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study of JNJ-86974680 in Participants With Advanced Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06116786.