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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: JNJ-90301900
    JNJ-90301900 will be injected intratumorally and/or intranodally.
  • Biological: Durvalumab
    Durvalumab will be administered as intravenous (IV) infusion as cIT.
  • Radiation: Concurrent Chemo/Radiation Therapy (cCRT)
    Radiation by intensity modulated radiation therapy (IMRT) will be administered.
  • Drug: Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin
    Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy.
  • Drug: Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel
    Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy.
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.
  • Drug: JNJ-90301900
    JNJ-90301900 will be injected intratumorally and/or intranodally.
  • Biological: Durvalumab
    Durvalumab will be administered as intravenous (IV) infusion as cIT.
  • Radiation: Concurrent Chemo/Radiation Therapy (cCRT)
    Radiation by intensity modulated radiation therapy (IMRT) will be administered.
  • Drug: Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin
    Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy.
  • Drug: Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel
    Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy.
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.
  • Biological: Durvalumab
    Durvalumab will be administered as intravenous (IV) infusion as cIT.
  • Radiation: Concurrent Chemo/Radiation Therapy (cCRT)
    Radiation by intensity modulated radiation therapy (IMRT) will be administered.
  • Drug: Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin
    Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy.
  • Drug: Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel
    Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy.

Recruiting Locations

Moores Cancer Center at UC San Diego Health
La Jolla, California 92037

University of Connecticut Health Center
Farmington, Connecticut 06030

Yale University
New Haven, Connecticut 06519

University of Miami
Miami, Florida 33136

Orlando Health Cancer Institute
Orlando, Florida 32806

Emory University Winship Cancer Institute
Atlanta, Georgia 30306

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215

Washington University in St Louis
St Louis, Missouri 63130

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901

NYU Langone Health
New York, New York 10016

Memorial Sloan Kettering Cancer Center
New York, New York 10065

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27514

FirstHealth of the Carolinas
Pinehurst, North Carolina 28374

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106

Oregon Health And Science University
Portland, Oregon 97239

University of Pennsylvania
Philadelphia, Pennsylvania 19104

MD Anderson Cancer Center
Houston, Texas 77030

University of Vermont Medical Center
Burlington, Vermont 05401

More Details

Status
Recruiting
Sponsor
Johnson & Johnson Enterprise Innovation Inc.

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.