Study Details

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Study for Patients with Non-small Cell Lung Cancer

The purpose of this study is to see how well the injection of the radiation enhancer (JNJ-90301900) into your cancer before you receive chemoradiotherapy followed by immunotherapy compares to chemoradiotherapy alone followed by immunotherapy.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

You will meet with the clinical staff to complete screening tests to see if you are eligible to take part in this study. These tests include physical exam, labs, heart tests, questionnaires, and imaging. If you are found eligible, you will be put into a treatment group. Your placement is based on when you join the study. It is possible you do not receive the study drug and only receive chemoradiation followed by a different drug included in this study. If you are placed into a treatment group that receives the study drug, JNJ-90301900, you will receive it as injections into your tumor(s). You will receive chemotherapy and radiation therapy every week for 6 weeks. You will then receive immunotherapy every 2 to 4 weeks for up to 1 year. You will also have labs and imaging during this time. After your treatment, you will have an end of treatment visit with exam, labs, and imaging. You will also come in for follow up visits.

Incentives

A per visit reimbursement/stipend will be given to help with incidental expenses related to attending study visits . A caregiver (if applicable) will receive a payment as well., Travel assistance (car service, train, airfare, hotel arrangement, etc.) may be offered for study visits and convenience.

In-person visits:
Between 53 and 66 visits, number of visits depend on treatment arm

Total length of participation:
About 28 months

Looking for Specific Volunteers

Able to participate:

Have locally advanced Stage IIIA or IIIB Non-small Cell Lung Cancer that cannot be resected
Have at least 1 target tumor that can be injected
Do not have known EGFR or ALK mutation
Adequate labs values per protocol
Agree to use contraceptives during treatment

Not eligible if:

History of uncontrolled illnesses, such as: autoimmune disorders, end-stage kidney disease, severe liver disease, bacterial/fungal infection needing antibiotics
Heart events within 3 months of study enrollment (severe angina, heart attack, thromboembolic event)
Positive for HIV and meets criteria per protocol
Has received anti-cancer therapy within 36 months of signing consent
Presence of metastatic disease

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Ashley Weiner
Lineberger Comprehensive Cancer Center

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Lung)

IRB Number

24-1840

ClinicalTrials.gov

NCT06667908