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

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

First listed

Oct 31, 2024

Start date

Dec 6, 2024

Status verified

Jul 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

• Study Contact
  844-434-4210
  [email protected]

Locations (18)

Find similar trials in La Jolla, CA

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