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

Part of paid clinical trials in Farmington, Connecticut.

Sponsor
Johnson & Johnson Enterprise Innovation Inc.
Study ID
NCT06667908
Phase
PHASE2
Status
Recruiting
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Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Dec 6, 2024
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
University of Connecticut Health CenterFarmingtonConnecticut06030-
Yale UniversityNew HavenConnecticut06519-
University of MiamiMiamiFlorida33136-
Orlando Health Cancer InstituteOrlandoFlorida32806-
Emory University Winship Cancer InstituteAtlantaGeorgia30306-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
NYU Langone HealthNew YorkNew York10016-
University of North Carolina at Chapel HillChapel HillNorth Carolina27514-
FirstHealth of the CarolinasPinehurstNorth Carolina28374-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Oregon Health And Science UniversityPortlandOregon97239-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
MD Anderson Cancer CenterHoustonTexas77030-
University of Vermont Medical CenterBurlingtonVermont05401-

Find similar trials in Farmington, CT

By research site
University of Connecticut Health Center· Farmington, CTYale University· New Haven, CTUniversity of Miami· Miami, FLOrlando Health Cancer Institute· Orlando, FLEmory University Winship Cancer Institute· Atlanta, GABeth Israel Deaconess Medical Center· Boston, MA

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