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A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

RecruitingPhase 2

A Phase 2, Randomized, Open-Label, Active-Controlled Study of JNJ-90301900 in Combination With Chemoradiation Followed by Durvalumab in Locally Advanced and Unresectable Stage III NSCLC

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Johnson & Johnson Enterprise Innovation Inc. · Participants: 130 · Started: Dec 6, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06667908

Locations in the U.S.

CaliforniaMoores Cancer Center at UC San Diego Health, La Jolla
ConnecticutYale University, New Haven
FloridaUniversity of Miami, Miami
Orlando Health Cancer Institute, Orlando
GeorgiaEmory University Winship Cancer Institute, Atlanta
MassachusettsBeth Israel Deaconess Medical Center, Boston
MissouriWashington University in St Louis, St Louis
New JerseyRutgers Cancer Institute of New Jersey, New Brunswick
New YorkMemorial Sloan Kettering Cancer Center, New York
NYU Langone Health, New York
North CarolinaUniversity of North Carolina at Chapel Hill, Chapel Hill
FirstHealth of the Carolinas, Pinehurst
OhioUniversity Hospitals Cleveland Medical Center, Cleveland
OregonOregon Health And Science University, Portland
PennsylvaniaUniversity of Pennsylvania, Philadelphia
TexasMD Anderson Cancer Center, Houston
VermontUniversity of Vermont Medical Center, Burlington

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.