Locally advanced and unresectable Stage III non-small cell lung cancer Cancer
Conditions
Interventions
Experimental: Part 1: Cohort A and Cohort B
Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (cohort A: 22% gross tumor volume [GTV] and cohort B: 33% GTV) along with
Sponsors
Johnson & Johnson (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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 2. Have a medical history of pathologically (histologically or cytologically) proven diagnosis of NSCLC within 3 months prior to enrolment/randomisation 3. Have locally advanced unresectable stage IIIA or IIIB NSCLC according to the eighth edition lung cancer stage classification 4. Have at least one 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 5. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
Exclusion criteria
Exclusion criteria: 1. Medical history of: 1.1. Primary immunodeficiency 1.2. Organ transplant that requires therapeutic immunosuppression 2. Any of the following within 3 months prior to enrolment/randomisation: 2.1. Severe or unstable angina 2.2. Myocardial infarction 2.3. Major thromboembolic events 2.4. Clinically significant ventricular arrhythmias 2.5. Heart failure classified as New York Heart Association (NYHA) functional class III to IV 3. Another concurrent or prior primary malignancy (other than NSCLC) within the last 36 months at informed consent 4. Known allergies, hypersensitivity, or intolerance to any ingredients of JNJ-90301900 crystalline solution, platinum-based doublet chemotherapy (ChT), or durvalumab 5. Active bleeding diathesis or requirement for therapeutic anticoagulation or antiplatelet therapy that cannot be interrupted or altered for procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) using Independent Central Review (ICR) assessment. ORR is defined as the percentage of participants who have a best response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version (v) 1.1 using ICR assessments. The timeframe for evaluation is up to 2 years and 2 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timeframe for evaluation is up to 12 weeks (DRR post-cCRT and pre-cIT and DCR post-cCRT and pre-cIT) and 2 years and 2 months for all other measures: 1. Disease response rate (DRR) post-cCRT and pre-cIT 2. Disease control rate (DCR) post-cCRT and pre-cIT 3. Objective response rate (ORR) as assessed by the Investigator according to RECIST v1.1 4. Progression-free survival (PFS) 5. Duration of response (DoR) 6. Time to locoregional failure (LRF) 7. Time to distant failure (DF) 8. Number of participants with treatment-emergent adverse events (TEAEs) related to study treatment 9. Number of participants reporting laboratory parameters, physical examination, vital signs, including Eastern Cooperative Oncology Group (ECOG) Performance Status abnormalities | — |
Countries
Australia, Brazil, China, France, Hong Kong, Netherlands, Spain, United Kingdom
Contacts
Public ContactJack Brady
Outcome results
None listed