Trial NCT06667908
A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)
- Phase
- Phase 2
- Sponsor
- Johnson & Johnson Enterprise Innovation Inc.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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 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 1Performance status
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, clinically significant ventricular arrhythmias or heart failure New York heart association functional classification class III to IVCardiac
* Another concurrent or prior primary malignancy within the last 36 months at informed consentPrior malignancy
* 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
Restrictions found (3)
- CardiacConditionalexclusion
within 3 months; NYHA class III to IV
Show in the text - Performance statusOutrightinclusion
ECOG 0 to 1
Show in the text - Prior malignancyOutrightexclusion
within 36 months
Show in the text
Recruiting in Massachusetts
- Beth Israel Deaconess Medical Center · Boston, Suffolk County