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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohnson & Johnson Enterprise Innovation Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • JNJ-90301900
  • Durvalumab
  • Concurrent Chemo/Radiation Therapy (cCRT)
  • Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin
  • Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel

Treatment groups

130 Participants
are divided into 3 treatment groups

Locations

41
Australia
Royal Brisbane and Women's Hospital4029, Herston Australia
Sir Charles Gairdner Hospital6009, Nedlands Australia
Macquarie University2109, North Ryde Australia
Royal Melbourne Hospital3050, Parkville Australia

Sponsors and collaborators

Johnson & Johnson Enterprise Innovation Inc.

Lead sponsor