Carcinoma, Non-Small-Cell Lung
Conditions
Brief 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.
Interventions
DRUGJNJ-90301900
JNJ-90301900 will be injected intratumorally and/or intranodally.
BIOLOGICALDurvalumab
Durvalumab will be administered as intravenous (IV) infusion as cIT.
RADIATIONConcurrent Chemo/Radiation Therapy (cCRT)
Radiation by intensity modulated radiation therapy (IMRT) will be administered.
DRUGConcurrent Chemo/Radiation Therapy (cCRT): Carboplatin
Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy.
DRUGConcurrent Chemo/Radiation Therapy (cCRT): Paclitaxel
Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy.
Sponsors
Johnson & Johnson Enterprise Innovation Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 1
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) Using Independent Central Review (ICR) Assessment | Up to 2 Years and 2 months | 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 tumors (RECIST) version (v) 1.1 using ICR assessments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) Post-cCRT and Pre-cIT | Up to 12 Weeks | Objective response rate is defined as percentage of participants who achieve CR or PR, post-concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) and pre-consolidation immunotherapy (cIT) based on investigator's assessment according to RECIST v1.1. |
| Disease Control Rate (DCR) Post-cCRT and Pre-cIT | Up to 12 Weeks | DCR is defined as percentage of participants who achieve CR, PR and stable disease post-cCRT and pre-cIT based on investigator's assessment according to RECIST v1.1. |
| Objective Response Rate (ORR) as Assessed by the Investigator | Up to 2 Years and 2 months | ORR is defined as the percentage of participants who have a best response of CR or PR using RECIST v1.1 as assessed by the investigator. |
| Progression Free Survival (PFS) | Up to 2 Years and 2 months | PFS is defined as the time from the enrollment/randomization until disease progression or death due to any cause according to RECIST v1.1. |
| Duration of Response (DoR) | Up to 2 Years and 2 months | DoR will be calculated among responders from the date of initial documentation of a response to the date of first documented evidence of relapse according to RECIST v1.1, or death due to any cause, whichever occurs first. |
| Time to Locoregional Failure (LRF) | Up to 2 Years and 2 months | Time to LRF is defined as the time from enrollment/randomization to the first LRF using ICR assessments. |
| Time to Distant Failure (DF) | Up to 2 Years and 2 months | Time to DF is defined as the time from enrollment/randomization to the first DF using ICR assessments. |
| Number of Participants with Treatment-Emergent Adverse Event (TEAE) Related to Study Treatment | Up to 2 Years and 2 months | TEAE is defined as any new or worsening adverse event (AE) occurring at or after the initial administration of study treatment through the day of last dose of study treatment received plus 30 days or prior to the start of subsequent anticancer therapy (non-durvalumab), whichever is earlier, or any follow-up AE with onset date and time beyond 30 days after the last dose of study treatment but prior to the start of subsequent anticancer therapy, or any AE that is considered treatment-related regardless of the start date of the event. TEAEs related to JNJ-90301900 injection procedure, JNJ-90301900, RT, ChT, or cIT will be reported. |
| Number of Participants Reporting Laboratory Parameters, Physical Examination, Vital Signs Including Eastern Cooperative Oncology Group (ECOG) Performance Status Abnormalities | Up to 2 Years and 2 months | Participants with laboratory parameters, physical examination, vital signs including ECOG performance status abnormalities will be reported. |
Countries
Australia, Brazil, China, France, Hong Kong, Netherlands, Spain, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJohnson & Johnson Enterprise Innovation Inc. Clinical Trial
Johnson & Johnson Enterprise Innovation Inc.
Outcome results
None listed