Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around

Description

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.

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

Keywords

Carcinoma, Non-Small-Cell Lung, Non-Small-Cell Lung Carcinoma, durvalumab, Radiotherapy, JNJ-90301900, Concurrent Chemo/Radiation Therapy (cCRT), Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin, Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 III 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 intensity modulated radiation therapy (IMRT) as determined by the investigator at screening
  • Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

You CAN'T join if...

  • 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, clinically significant ventricular arrhythmias or heart failure New York heart association functional classification class III to IV
  • Another concurrent or prior primary malignancy 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
  • History 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

  • Moores Cancer Center at UC San Diego Health accepting new patients
    La Jolla California 92037 United States
  • Oregon Health And Science University accepting new patients
    Portland Oregon 97239 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Johnson & Johnson Enterprise Innovation Inc.
ID
NCT06667908
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 130 study participants
Last Updated