JNJ-90301900 + Chemoradiation for Lung Cancer

(CONVERGE Trial)

Recruiting at 7 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Johnson & Johnson Enterprise Innovation Inc.

Must be taking: Platinum-based chemotherapy

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Primary immunodeficiency, Organ transplant, others

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether JNJ-90301900 added to concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) followed by consolidation immunotherapy (cIT) can improve objective response rate (ORR; that is percentage of participants whose best response is complete response or partial response during the study) in participants with locally advanced and unresectable stage III non-small cell lung cancer.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on medications for conditions like heart issues or require blood thinners, you may need to discuss this with the trial team, as some conditions and treatments might affect eligibility.

Research Team

Johnson & Johnson Enterprise Innovation Inc. Clinical Trial

Principal Investigator

Johnson & Johnson Enterprise Innovation Inc.

Eligibility Criteria

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.

Inclusion Criteria

I was diagnosed with non-small cell lung cancer in the last 3 months.

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

I am eligible for standard lung cancer treatment including chemotherapy, radiation, and durvalumab.

Exclusion Criteria

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

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

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemoradiation

Participants receive concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT)

Up to 12 weeks

Consolidation Immunotherapy

Participants receive consolidation immunotherapy (cIT) following chemoradiation

Up to 2 years and 2 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years and 2 months

Treatment Details

Interventions

• JNJ-90301900 (Cancer Vaccine)

Trial Overview 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.

Participant Groups

Group I: Part 2: Arm A and Arm B Experimental Treatment 5 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 B Experimental Treatment 5 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 Control 4 Interventions

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

Who Is Running the Clinical Trial?

Johnson & Johnson Enterprise Innovation Inc.

Lead Sponsor

Trials

5

Recruited

910+