Actively Recruiting
Using ctDNA to Determine Therapies for Lung Cancer
Led by University Health Network, Toronto · Updated on 2025-12-18
66
Participants Needed
1
Research Sites
244 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a study to look at whether the presence of circulating tumour DNA (ctDNA) in the blood can help to predict whether giving adjuvant treatment after surgery can decrease the chance of the cancer coming back in people with lung cancer.
CONDITIONS
Official Title
Using ctDNA to Determine Therapies for Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at screening
- Written informed consent obtained before any study procedures
- ECOG performance status of 0 or 1
- Weight of at least 35 kg
- Life expectancy of at least 24 months
- Complete surgical removal of T1-2N0M0 or T3/T4 multifocal NSCLC
- Any NSCLC subtype, including adenocarcinoma and squamous carcinoma
- Detectable plasma ctDNA before or after surgery
- No prior chemotherapy or radiotherapy for current NSCLC
- Adequate organ and marrow function as defined in study
- Females of childbearing potential must use effective contraception during study and 180 days after last treatment
- Non-sterilized males with female partners of childbearing potential must use condoms with spermicide during study and 180 days after last treatment
You will not qualify if you...
- Need for adjuvant chemotherapy per standard care due to resected N1 or N2 disease or tumor size �3 cm
- Receipt of anticancer therapy within 21 days or radiotherapy within 14 days prior to first study dose
- Prior immune-mediated anticancer therapy including anti-PD-1/PD-L1 agents like nivolumab
- Incomplete surgical tumor removal
- Concurrent enrollment in another systemic anticancer treatment study
- Recent myocardial infarction, severe heart failure, or stroke within 3 months
- Active autoimmune disorders within past 3 years except certain stable conditions
- Uncontrolled HIV infection; controlled HIV allowed with conditions
- History of primary immunodeficiency, organ transplant, or active tuberculosis
- Other invasive cancers within 2 years except certain non-invasive types
- Allergies to study drugs or formulations
- History of infusion reactions requiring stopping IV drug treatment
- Uncontrolled infections, hypertension, bleeding disorders, or psychiatric/social issues limiting compliance
- Use of immunosuppressive medication within 14 days except certain corticosteroids
- Live vaccine within 30 days before first dose; live vaccines prohibited during study and 180 days after
- Major surgery within 28 days before first dose or still recovering
- Pregnant or breastfeeding females or intending pregnancy during study
- Involuntary incarceration or inability to consent or comply
- Any condition interfering with safe treatment or study evaluation as judged by investigator
- Allergic reactions to compounds similar to nivolumab or other study agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
N
Natasha Leighl, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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