Recruiting
Phase 2

JNJ-90301900 & Chemoradiation

Sponsor:

Johnson & Johnson Enterprise Innovation Inc.

Code:

NCT06667908

Conditions

Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JNJ-90301900

Durvalumab

Concurrent Chemo/Radiation Therapy (cCRT)

Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin

Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel

Study Details

Brief summary:

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Study ID

NCT06667908

Start date

Dec 6, 2024

Status verified date

Aug, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Must be a candidate for standard of care (SOC) treatment of non small cell lung cancer (NSCLC) by concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) followed by consolidation durvalumab treatment as determined by the investigator and per local guidelines at screening
  • Have a medical history of pathologically (histologically or cytologically) proven diagnosis of NSCLC within 3 months prior to enrollment/randomization
  • Have locally advanced unresectable stage III 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 intensity modulated radiation therapy (IMRT) as determined by the investigator at screening
  • Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

Exclusion Criteria:

  • Medical history of: (a) Primary immunodeficiency (b) Organ transplant that requires therapeutic immunosuppression
  • Any of the following within 3 months prior to enrollment/randomization: severe or unstable angina, myocardial infarction, clinically significant ventricular arrhythmias or heart failure New York heart association functional classification class III to IV
  • Another concurrent or prior primary malignancy within the last 36 months at informed consent
  • Known allergies, hypersensitivity, or intolerance to any ingredients of JNJ-90301900 crystalline solution, platinum-based doublet chemotherapy (ChT), or durvalumab
  • History of coagulation disorders, including: (a) Active bleeding diathesis or requirement for therapeutic anticoagulation or antiplatelet that cannot be interrupted or altered for JNJ-90301900 injection procedures, (b) Major thromboembolic events (for example, pulmonary embolism, cerebrovascular accident) within 3 months of enrollment or randomization

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: Cohort A and Cohort B

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.

experimental: Part 2: Arm A and Arm B

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.

active comparator: Part 2: Arm C: (Control treatment)

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

Interventions

JNJ-90301900

JNJ-90301900 will be injected intratumorally and/or intranodally.

Durvalumab

Durvalumab will be administered as intravenous (IV) infusion as cIT.

Concurrent Chemo/Radiation Therapy (cCRT)

Radiation by intensity modulated radiation therapy (IMRT) will be administered.

Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin

Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy.

Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel

Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy.

Primary outcome measure

  • Objective Response Rate (ORR) Using Independent Central Review (ICR) Assessment [ Time Frame: Up to 2 Years and 2 months ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

Moores Cancer Center at UC San Diego Health

Recruiting

La Jolla, California, United States, 92037

University of Connecticut Health Center

Recruiting

Farmington, Connecticut, United States, 06030

Yale University

Recruiting

New Haven, Connecticut, United States, 06519

University of Miami

Recruiting

Miami, Florida, United States, 33136

Orlando Health Cancer Institute

Recruiting

Orlando, Florida, United States, 32806

Emory University Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30306

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Washington University in St Louis

Recruiting

St Louis, Missouri, United States, 63130

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

FirstHealth of the Carolinas

Recruiting

Pinehurst, North Carolina, United States, 28374

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Oregon Health And Science University

Recruiting

Portland, Oregon, United States, 97239

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

More Information

Sponsor

Johnson & Johnson Enterprise Innovation Inc.

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johnson & Johnson Enterprise Innovation Inc. on 2026-08-28.