JNJ-90301900 + Chemoradiation for Lung Cancer

(CONVERGE Trial)

Recruiting at 28 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

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 All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called JNJ-90301900 for individuals with a specific type of lung cancer that cannot be surgically removed. Researchers aim to determine if adding JNJ-90301900 to standard chemotherapy and radiation can shrink tumors more effectively than the standard treatment alone. The trial includes three groups: two will receive JNJ-90301900 with standard treatment, and one will receive only the standard treatment. Suitable candidates for this trial have stage III non-small cell lung cancer that has not spread beyond the lungs and have been diagnosed within the last three months. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that JNJ-90301900 is being tested for safety when combined with chemoradiation therapy for lung cancer patients. Although detailed safety information from earlier studies isn't available, this treatment is now in Phase 2 trials, indicating it has already undergone safety testing in smaller groups.

In these trials, the treatment is injected directly into the tumor or lymph nodes. This targeted approach has been used in other treatments to focus on cancer more directly, potentially reducing side effects compared to systemic treatments. However, specific details about the tolerance of JNJ-90301900 or any side effects are not yet available.

Since this trial is in Phase 2, researchers continue to learn about its safety and patient responses. This phase is crucial to ensure the treatment does not cause harmful effects before testing on larger groups. As testing progresses, more detailed safety information will become available. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lung cancer?

Researchers are excited about JNJ-90301900 for lung cancer because it introduces a unique approach by being injected directly into the tumor or lymph nodes, which is different from the usual systemic delivery methods like intravenous chemotherapy. This localized delivery targets tumor sites more precisely, potentially increasing the treatment's effectiveness while minimizing side effects elsewhere in the body. Additionally, when combined with chemoradiation and consolidation immunotherapy, JNJ-90301900 could enhance the overall treatment response, offering a promising new option beyond the standard chemotherapy and radiation therapies typically used for lung cancer.

What evidence suggests that this trial's treatments could be effective for lung cancer?

Research has shown that JNJ-90301900 might enhance standard lung cancer treatments. In this trial, participants in Part 2: Arm A and Arm B will receive JNJ-90301900 injected intratumorally and/or intranodally, alongside chemoradiation therapy, to evaluate its efficacy and safety. The researchers aim for JNJ-90301900 to shrink tumors more effectively than chemoradiation alone. By injecting it directly into the tumor area, the treatment seeks to maximize impact. Early results suggest it could help more patients experience tumor reduction. Although this method is still under study, initial findings are promising. ^{1 2 3 4 6}

Who Is on the Research Team?

Johnson & Johnson Enterprise Innovation Inc. Clinical Trial

Principal Investigator

Johnson & Johnson Enterprise Innovation Inc.

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• JNJ-90301900

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06667908

NCT06667908 | A Study of JNJ-90301900 in Combination ... The purpose of this study is to determine whether JNJ-90301900 added to concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) followed ...

2. isrctn.com isrctn.com/pdf/81039232

A study of JNJ-90301900 in combination with ... In this study, researchers want to assess if JNJ-90301900 as a radioenhancer added to cCRT followed by cIT can improve objective response rate ( ...

3. clinicaltrials.eu clinicaltrials.eu/trial/study-of-jnj-90301900-with-chemoradiation-and-durvalumab-for-patients-with-advanced-non-small-cell-lung-cancer/

Study of JNJ-90301900 with Chemoradiation and ... The main goal is to evaluate the effectiveness of the drug JNJ-90301900 when used with standard treatments.

4. clin.larvol.com clin.larvol.com/trial-detail/NCT04892173

JNJ-90301900 (NBTXR3) Activated by Radiotherapy With ... Futility analysis to be conducted following 25% of planned PFS events expected in H1 24; Initial Phase 3 interim efficacy and safety data expected after 67% of ...

5. ctv.veeva.com ctv.veeva.com/study/a-study-of-jnj-90301900-in-combination-with-chemoradiation-followed-by-consolidation-immunotherapy-f

A Study of JNJ-90301900 in Combination With ... The purpose of this study is to determine whether JNJ-90301900 added to concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) followed ...

6. withpower.com withpower.com/trial/phase-2-carcinoma-non-small-cell-lung-9-2024-e9947

JNJ-90301900 + Chemoradiation for Lung Cancer 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 ...