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

Johnson & Johnson (J&J)

Status and phase

Enrolling

Phase 2

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Biological: Durvalumab

Drug: JNJ-90301900

Drug: Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel

Radiation: Concurrent Chemo/Radiation Therapy (cCRT)

Drug: Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT06667908

90301900NSC2001

2024-518276-32-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

130 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

130 participants in 3 patient groups

Part 1: Cohort A and Cohort B

Experimental group

Description:

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.

Treatment:

Drug: Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin

Radiation: Concurrent Chemo/Radiation Therapy (cCRT)

Drug: Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel

Drug: JNJ-90301900

Biological: Durvalumab

Part 2: Arm A and Arm B

Experimental group

Description:

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.

Treatment:

Drug: Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin

Radiation: Concurrent Chemo/Radiation Therapy (cCRT)

Drug: Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel

Drug: JNJ-90301900

Biological: Durvalumab

Part 2: Arm C: (Control treatment)

Active Comparator group

Description:

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

Treatment:

Drug: Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin