RightFit
RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding JNJ-90301900 to chemotherapy and radiation, followed by immune treatment, helps more people's tumors shrink or disappear. It is for people with stage III non-small cell lung cancer that has spread nearby and cannot be removed by surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Your study doctor must decide you can receive standard chemotherapy and radiation together, followed by durvalumab, an immune treatment.
  • Your lung cancer must have been confirmed by a tissue or cell test within 3 months before joining the study.
  • You must have stage III non-small cell lung cancer that has spread nearby and cannot be removed by surgery.
  • You must have at least one tumor in the lung or an affected lymph node that meets study measurement rules and can receive direct injections and focused radiation.
  • You must be fully active or able to do light work, even if you cannot do hard physical activity.

Who can't join

  • You have a primary immune deficiency, a condition that weakens your body's defenses, or an organ transplant that requires medicine to lower your immune response.
  • In the past 3 months, you had severe or unstable chest pain from heart disease, a heart attack, serious abnormal rhythms in the heart's lower chambers, or severe heart failure.
  • You have another cancer or had another cancer within 36 months before giving consent.
  • You have a known allergy or cannot tolerate any ingredient in the study drug, the platinum-based chemotherapy, or durvalumab.
  • You have a blood-clotting disorder, including a current tendency to bleed, or need blood-thinning medicine that cannot be stopped or changed for study drug injections.
  • You had a major blood clot event, such as a clot in the lung or a stroke, within 3 months before joining the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (18)

CA

CT

FL

GA

MA

MO

NC

NJ

NY

OH

OR

PA

TX

VT