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

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

NCT ID: NCT06667908

Condition: Carcinoma, Non-Small-Cell Lung

Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Carboplatin
Durvalumab

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: JNJ-90301900
Description: JNJ-90301900 will be injected intratumorally and/or intranodally.
Arm group label: Part 1: Cohort A and Cohort B
Arm group label: Part 2: Arm A and Arm B

Intervention type: Biological
Intervention name: Durvalumab
Description: Durvalumab will be administered as intravenous (IV) infusion as cIT.
Arm group label: Part 1: Cohort A and Cohort B
Arm group label: Part 2: Arm A and Arm B
Arm group label: Part 2: Arm C: (Control treatment)

Intervention type: Radiation
Intervention name: Concurrent Chemo/Radiation Therapy (cCRT)
Description: Radiation by intensity modulated radiation therapy (IMRT) will be administered.
Arm group label: Part 1: Cohort A and Cohort B
Arm group label: Part 2: Arm A and Arm B
Arm group label: Part 2: Arm C: (Control treatment)

Intervention type: Drug
Intervention name: Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin
Description: Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy.
Arm group label: Part 1: Cohort A and Cohort B
Arm group label: Part 2: Arm A and Arm B
Arm group label: Part 2: Arm C: (Control treatment)

Intervention type: Drug
Intervention name: Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel
Description: Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy.
Arm group label: Part 1: Cohort A and Cohort B
Arm group label: Part 2: Arm A and Arm B
Arm group label: Part 2: Arm C: (Control treatment)

Summary: 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.

Criteria for 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 IIIA or IIIB 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 external beam radiation therapy (EBRT) 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, major thromboembolic events, clinically significant ventricular arrhythmias or heart failure new york heart association functional classification class III to IV - Another concurrent or prior primary malignancy (other than NSCLC) 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 - Active bleeding diathesis or requirement for therapeutic anticoagulation or antiplatelet that cannot be interrupted or altered for procedures

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Banner MD Anderson Cancer Center

Address:
City: Gilbert
Zip: 85234
Country: United States

Facility:
Name: Yale University

Address:
City: New Haven
Zip: 06519
Country: United States

Facility:
Name: University Hospitals Cleveland Medical Center

Address:
City: Cleveland
Zip: 44106
Country: United States

Start date: October 31, 2024

Completion date: December 31, 2028

Lead sponsor:
Agency: Johnson & Johnson Enterprise Innovation Inc.
Agency class: Industry

Source: Johnson & Johnson Enterprise Innovation Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06667908