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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment130 people
  • Recruiting US sites17
  • SponsorJohnson & Johnson Enterprise Innovation Inc.
  • RegistryNCT06667908

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC): a one-minute explainerNCT066679081 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • 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

You cannot join if

  • 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

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

durvalumab. A monoclonal antibody directed against B7H1 (B7 homolog 1; programmed cell death ligand 1) with potential immunostimulating activity. Upon intravenous administration, durvalumab binds to the cell surface antigen B7H1, thereby blocking B7H1 signaling. This may activate the immune system to exert a cytotoxic T-lymphocyte (CTL) response against B7H1-expressing tumor cells. B7H1, a member of the B7 protein superfamily and a negative regulator of cytokine synthesis, is overexpressed on certain tumor cell types. NCI Drug Dictionary

Treatments listed in the registry

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

The study

Treatment groups

Randomized · Parallel · masking: None

Part 1: Cohort A and Cohort B (Experimental)

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.

Part 2: Arm A and Arm B (Experimental)

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.

Part 2: Arm C: (Control treatment) (Active Comparator)

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

What it involves

Procedures

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

  • radiation: Part of the study plan

Goals

What the study measures

Main goals

  • Objective Response Rate (ORR) Using Independent Central Review (ICR) Assessment (Up to 2 Years and 2 months)

Other goals

  • Objective Response Rate (ORR) Post-cCRT and Pre-cIT
  • Disease Control Rate (DCR) Post-cCRT and Pre-cIT
  • Objective Response Rate (ORR) as Assessed by the Investigator
  • Progression Free Survival (PFS)
  • Duration of Response (DoR)
  • Time to Locoregional Failure (LRF)
  • Time to Distant Failure (DF)
  • Number of Participants with Treatment-Emergent Adverse Event (TEAE) Related to Study Treatment
  • Number of Participants Reporting Laboratory Parameters, Physical Examination, Vital Signs Including Eastern Cooperative Oncology Group (ECOG) Performance Status Abnormalities

Planned enrollment: 130 (estimated).

Where

Recruiting US sites

  • Moores Cancer Center at UC San Diego Health, La Jolla, California
  • Yale University, New Haven, Connecticut
  • University of Miami, Miami, Florida
  • Orlando Health Cancer Institute, Orlando, Florida
  • Emory University Winship Cancer Institute, Atlanta, Georgia
  • Beth Israel Deaconess Medical Center, Boston, Massachusetts
  • Washington University in St Louis, St Louis, Missouri
  • Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey
  • NYU Langone Health, New York, New York
  • Memorial Sloan Kettering Cancer Center, New York, New York
  • University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
  • FirstHealth of the Carolinas, Pinehurst, North Carolina
  • University Hospitals Cleveland Medical Center, Cleveland, Ohio
  • Oregon Health And Science University, Portland, Oregon
  • University of Pennsylvania, Philadelphia, Pennsylvania
  • MD Anderson Cancer Center, Houston, Texas
  • University of Vermont Medical Center, Burlington, Vermont

26 recruiting sites outside the US. Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 24, 2026. Public record; not medical advice.

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