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Back|NCT06667908Recruiting
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

Phase
Phase 2
Sponsor
Johnson & Johnson Enterprise Innovation Inc.
Enrollment
130
Timeline
Dec 2024 → Dec 2028
About This Study

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

  • 1Must 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
  • 2Have a medical history of pathologically (histologically or cytologically) proven diagnosis of NSCLC within 3 months prior to enrollment/randomization
  • 3Have locally advanced unresectable stage III NSCLC according to the eighth edition lung cancer stage classification
  • 4Have 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
  • 5Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

Exclusion Criteria

  • 1Medical history of: (a) Primary immunodeficiency (b) Organ transplant that requires therapeutic immunosuppression
  • 2Any 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
  • 3Another concurrent or prior primary malignancy within the last 36 months at informed consent
  • 4Known allergies, hypersensitivity, or intolerance to any ingredients of JNJ-90301900 crystalline solution, platinum-based doublet chemotherapy (ChT), or durvalumab
  • 5History 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

Locations

32 sites participating in this study

Emory University Winship Cancer Institute

Atlanta, Georgia 30306

Recruiting

University of Connecticut Health Center

Farmington, Connecticut 06030

Recruiting

Orlando Health Cancer Institute

Orlando, Florida 32806

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →