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

Description

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Overview

Study Details

Study overview

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.

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

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

Condition
Carcinoma, Non-Small-Cell Lung
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale University, New Haven, Connecticut, United States, 06519

Orlando

Orlando Health Cancer Institute, Orlando, Florida, United States, 32806

New Brunswick

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States, 08901

Pinehurst

FirstHealth of the Carolinas, Pinehurst, North Carolina, United States, 28374

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johnson & Johnson Enterprise Innovation Inc.,

Johnson & Johnson Enterprise Innovation Inc. Clinical Trial, STUDY_DIRECTOR, Johnson & Johnson Enterprise Innovation Inc.

Study Record Dates

2028-12-31