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Cancer Vaccine

JNJ-90301900 + Chemoradiation for Lung Cancer (CONVERGE Trial)

Phase 2

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

Have locally advanced unresectable stage IIIA or IIIB NSCLC according to the eighth edition lung cancer stage classification

Have at least 1 target lesion (primary lung lesion or involved lymph node[s]) per RECIST version 1.1 that is amenable to intratumoral and/or intranodal injection and external beam radiation therapy (EBRT) as determined by the investigator at screening

Must not have

Medical history of: Primary immunodeficiency, Organ transplant that requires therapeutic immunosuppression

Any of the following within 3 months prior to enrollment/randomization: severe or unstable angina, myocardial infarction, major thromboembolic events, clinically significant ventricular arrhythmias or heart failure new york heart association functional classification class III to IV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years and 2 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if adding JNJ-90301900 to standard chemotherapy and radiation, followed by immunotherapy, can improve the response rate in patients with advanced non-small cell lung cancer.

Who is the study for?

This trial is for individuals with stage III non-small cell lung cancer that cannot be removed by surgery. Participants should not have had prior treatments for this condition and must be able to undergo chemotherapy combined with radiation therapy.

What is being tested?

The study tests if adding JNJ-90301900 to standard chemo (Paclitaxel, Carboplatin) plus radiation improves response rates in patients. After these treatments, participants will receive consolidation immunotherapy to see if it further benefits them.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as inflammation of organs, infusion-related reactions from the drugs given through veins, fatigue, nausea from chemotherapy, and potential increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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My lung cancer is at an advanced stage but cannot be removed with surgery.

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I have a lung or lymph node cancer lesion that can be treated with direct injections and radiation.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a primary immunodeficiency or have had an organ transplant requiring immunosuppression.

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I haven't had severe heart issues like a heart attack or serious arrhythmias in the last 3 months.

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I have not had another primary cancer besides NSCLC in the last 3 years.

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I am not allergic to JNJ-90301900, platinum-based chemotherapy, or durvalumab.

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I have a bleeding disorder or need blood-thinning medication that can't be stopped.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years and 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years and 2 months

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR) Using Independent Central Review (ICR) Assessment

Secondary study objectives

Disease Control Rate (DCR) Post-cCRT and Pre-cIT

Disease Response Rate Post-cCRT and Pre-cIT

Duration of Response (DoR)

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Part 2: Arm A and Arm BExperimental Treatment5 Interventions

Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (Arm A: 22% GTV and Arm B: 33% GTV) along with cCRT followed by cIT to evaluate the efficacy and safety of JNJ-90301900.

Group II: Part 1: Cohort A and Cohort BExperimental Treatment5 Interventions

Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (cohort A: 22% gross tumor volume \[GTV\] and cohort B: 33% GTV) along with cCRT (concurrent chemotherapy with radiation therapy) followed by consolidation immunotherapy (cIT) to evaluate feasibility of JNJ-90301900 injection procedure.

Group III: Part 2: Arm C: (Control treatment)Active Control4 Interventions

Participants will receive treatment with cCRT followed by cIT as control treatment to evaluate the efficacy and safety of JNJ-90301900.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3750

0 / 8Eligibility criteria met