A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Interventions
- Registration Number
- NCT06667908
- Lead Sponsor
- Johnson & Johnson Enterprise Innovation Inc.
- 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 partic...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 130
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Cohort A and Cohort B JNJ-90301900 Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (cohort A: 22% gross tumor volume \[GTV\] and cohort B: 33% GTV) along with cCRT (concurrent chemotherapy with radiation therapy) followed by consolidation immunotherapy (cIT) to evaluate feasibility of JNJ-90301900 injection procedure. Part 1: Cohort A and Cohort B Durvalumab Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (cohort A: 22% gross tumor volume \[GTV\] and cohort B: 33% GTV) along with cCRT (concurrent chemotherapy with radiation therapy) followed by consolidation immunotherapy (cIT) to evaluate feasibility of JNJ-90301900 injection procedure. Part 1: Cohort A and Cohort B Concurrent Chemo/Radiation Therapy (cCRT) Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (cohort A: 22% gross tumor volume \[GTV\] and cohort B: 33% GTV) along with cCRT (concurrent chemotherapy with radiation therapy) followed by consolidation immunotherapy (cIT) to evaluate feasibility of JNJ-90301900 injection procedure. Part 2: Arm A and Arm B JNJ-90301900 Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (Arm A: 22% GTV and Arm B: 33% GTV) along with cCRT followed by cIT to evaluate the efficacy and safety of JNJ-90301900. Part 2: Arm A and Arm B Durvalumab Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (Arm A: 22% GTV and Arm B: 33% GTV) along with cCRT followed by cIT to evaluate the efficacy and safety of JNJ-90301900. Part 2: Arm A and Arm B Concurrent Chemo/Radiation Therapy (cCRT) Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (Arm A: 22% GTV and Arm B: 33% GTV) along with cCRT followed by cIT to evaluate the efficacy and safety of JNJ-90301900. Part 2: Arm C: (Control treatment) Durvalumab Participants will receive treatment with cCRT followed by cIT as control treatment to evaluate the efficacy and safety of JNJ-90301900. Part 2: Arm C: (Control treatment) Concurrent Chemo/Radiation Therapy (cCRT) Participants will receive treatment with cCRT followed by cIT as control treatment to evaluate the efficacy and safety of JNJ-90301900.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Disease Response Rate Post-cCRT and Pre-cIT Up to 12 Weeks Disease 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 th...
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.
Trial Locations
- Locations (5)
Orlando Health Cancer Institute
🇺🇸Orlando, Florida, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
FirstHealth of the Carolinas
🇺🇸Pinehurst, North Carolina, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Yale University
🇺🇸New Haven, Connecticut, United States