Clinical trial NCT06667908: A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Johnson & Johnson Enterprise Innovation Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-31
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Objective Response Rate (ORR) Using Independent Central Review (ICR) Assessment
timeFrame: Up to 2 Years and 2 months
Secondary outcomes:
measure: Disease Response Rate Post-cCRT and Pre-cIT
timeFrame: Up to 12 Weeks
measure: Disease Control Rate (DCR) Post-cCRT and Pre-cIT
timeFrame: Up to 12 Weeks
measure: Objective Response Rate (ORR) as Assessed by the Investigator
timeFrame: Up to 2 Years and 2 months
measure: Progression Free Survival (PFS)
timeFrame: Up to 2 Years and 2 months
measure: Duration of Response (DoR)
timeFrame: Up to 2 Years and 2 months
measure: Time to Locoregional Failure (LRF)
timeFrame: Up to 2 Years and 2 months
measure: Time to Distant Failure (DF)
timeFrame: Up to 2 Years and 2 months
measure: Number of Participants with Treatment-Emergent Adverse Event (TEAE) Related to Study Treatment
timeFrame: Up to 2 Years and 2 months
measure: Number of Participants Reporting Laboratory Parameters, Physical Examination, Vital Signs Including Eastern Cooperative Oncology Group (ECOG) Performance Status Abnormalities
timeFrame: Up to 2 Years and 2 months
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Orlando
country: United States
facility: Orlando Health Cancer Institute
state: Florida
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth of the Carolinas
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Istanbul
country: Turkey
facility: Medipol Acibadem Bolge Hastanesi
Study officials:
affiliation: Johnson & Johnson Enterprise Innovation Inc.
name: Johnson & Johnson Enterprise Innovation Inc. Clinical Trial
role: STUDY_DIRECTOR
References: