A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

Phase 2RecruitingNCT06667908

Johnson & Johnson Enterprise Innovation Inc.130 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

JNJ-90301900DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (41)

University of Connecticut Health Center

Farmington, Connecticut, United States

RECRUITING

Yale University

New Haven, Connecticut, United States

RECRUITING

University of Miami

Miami, Florida, United States

RECRUITING

Orlando Health Cancer Institute

Orlando, Florida, United States

Outcomes

Primary Outcomes

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 tumors (RECIST) version (v) 1.1 using ICR assessments.

Time frame: Up to 2 Years and 2 months

Secondary Outcomes

Objective Response Rate (ORR) Post-cCRT and Pre-cIT

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.

Time frame: Up to 12 Weeks

Disease Control Rate (DCR) Post-cCRT and Pre-cIT

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.

Time frame: Up to 12 Weeks

Objective Response Rate (ORR) as Assessed by the Investigator

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.

Time frame: Up to 2 Years and 2 months

Progression Free Survival (PFS)

PFS is defined as the time from the enrollment/randomization until disease progression or death due to any cause according to RECIST v1.1.

Time frame: Up to 2 Years and 2 months

Duration of Response (DoR)

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 frame: Up to 2 Years and 2 months

Time to Locoregional Failure (LRF)

Time to LRF is defined as the time from enrollment/randomization to the first LRF using ICR assessments.

Time frame: Up to 2 Years and 2 months

Time to Distant Failure (DF)

Time to DF is defined as the time from enrollment/randomization to the first DF using ICR assessments.

Time frame: Up to 2 Years and 2 months

Number of Participants with Treatment-Emergent Adverse Event (TEAE) Related to Study Treatment

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.

Time frame: Up to 2 Years and 2 months

Number of Participants Reporting Laboratory Parameters, Physical Examination, Vital Signs Including Eastern Cooperative Oncology Group (ECOG) Performance Status Abnormalities

Participants with laboratory parameters, physical examination, vital signs including ECOG performance status abnormalities will be reported.

Time frame: Up to 2 Years and 2 months

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

Overview

Conditions

Interventions

Eligibility

Locations (41)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts