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.

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

Carcinoma, Non-Small-Cell Lung

Carcinoma, Non-small-Cell Lung

Carcinoma, Non-Small Cell Lung

Non-Small Cell Lung Cancer

Non-Small-Cell Lung Carcinoma

Lung Cancer

Lung; Node

Cancer of the Lung

Cancer of Lung

Neoplasms, Lung

Lung Neoplasms

Advanced Solid Tumors

Cancer

Advanced Solid Malignancies

Advanced Solid Tumor

Solid Tumor, Adult

Neoplasms

Adenocarcinoma

Advanced Stage Solid Tumors

JNJ-90301900

Durvalumab

Concurrent Chemo/Radiation Therapy (cCRT)

Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin

Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel

A Phase 2, Randomized, Open-Label, Active-Controlled Study of JNJ-90301900 in Combination With Chemoradiation Followed by Durvalumab in Locally Advanced and Unresectable Stage III NSCLC

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.

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.

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.

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.

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

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

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

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.

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

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.

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.

Participants will receive treatment with cCRT followed by cIT as control treatment to evaluate the efficacy and safety of JNJ-90301900.

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.

University of Connecticut Health Center

Orlando Health Cancer Institute

Emory University Winship Cancer Institute

NYU Langone Health

Memorial Sloan Kettering Cancer Center

University of North Carolina at Chapel Hill

FirstHealth of the Carolinas

University of Pennsylvania

MD Anderson Cancer Center

University of Vermont Medical Center

Royal Melbourne Hospital

Hosp. Univ. 12 de Octubre

Clinica Univ. de Navarra

Hosp. Clinico Univ. de Santiago

Hosp. Univ. I Politecni La Fe

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.

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.

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.

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.

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

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

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

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.

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

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.

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.

Participants will receive treatment with cCRT followed by cIT as control treatment to
evaluate the efficacy and safety of JNJ-90301900.

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

Trials at a glance

Trials at a glance

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

Outcome measures

Primary outcome measures

Secondary outcome measures