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New treatment option for Non Small Cell Lung Cancer
Official title Using ctDNA to Determine Therapies for Lung Cancer
ClinicalTrials.gov ID: NCT04966663
What this study is testing
What is Nivolumab?
Nivolumab is an investigational medicine, being studied as a potential treatment for non small cell lung cancer.
Also referred to as Opdivo, ONO-4538.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years at the time of screening
- Written informed consent obtained from the subject prior to performing any protocol-related procedures
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Weight ≥ 35 kg
- Must have a life expectancy of at least 24 months
You likely can't join if
- Participants that should receive adjuvant chemotherapy per standard of care (resected N1 or N2 disease, primary tumour \>=4 cm).
- Receipt of any conventional or investigational anticancer therapy within 21 days or radiotherapy within 14 days prior to the scheduled first dose of...
- Prior receipt of any immune-mediated anti-cancer therapy including, but not limited to, anti-CTLA-4, anti-PD-1, anti-PD-L1 antibodies including...
- Incomplete surgical resection;
- Concurrent enrolment in another therapeutic clinical study of systemic anti-cancer treatment. Enrolment in observational or supportive studies will...
- people with a recent history of myocardial infarction, congestive heart failure ≥ Class 3 based on New York Heart Association Functional...
See the full eligibility criteria
Who can join
- Age ≥ 18 years at the time of screening
- Written informed consent obtained from the subject prior to performing any protocol-related procedures
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Weight ≥ 35 kg
- Must have a life expectancy of at least 24 months
- Complete surgical resection of T1-2N0M0 NSCLC or T3/T4 multifocal NSCLC
- Any pathologic subtype of NSCLC is eligible, including adenocarcinoma and squamous carcinoma. Patients with targetable genomic alterations without approved or available targeted adjuvant therapy options are eligible
- Patients with detectable plasma ctDNA before or after complete surgical resection are eligible (RaDaR TM assay, Inivata Morrisville, North Carolina, USA).
- No prior chemotherapy or radiotherapy is allowed for the current diagnosis of resected NSCLC.
- Adequate organ and marrow function as defined in Table 4 (3.1.1)
- Females of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception from screening to 180 days after the final dose of study...
- Non-sterilized male people who are sexually active with a female partner of childbearing potential must use a male condom with spermicide from screening to 180 days after receipt of the final dose of study treatment. It...
What rules you out
- Participants that should receive adjuvant chemotherapy per standard of care (resected N1 or N2 disease, primary tumour \>=4 cm).
- Receipt of any conventional or investigational anticancer therapy within 21 days or radiotherapy within 14 days prior to the scheduled first dose of study treatment;
- Prior receipt of any immune-mediated anti-cancer therapy including, but not limited to, anti-CTLA-4, anti-PD-1, anti-PD-L1 antibodies including nivolumab and agents targeting CD73, CD39, or adenosine receptors;
- Incomplete surgical resection;
- Concurrent enrolment in another therapeutic clinical study of systemic anti-cancer treatment. Enrolment in observational or supportive studies will be allowed;
- people with a recent history of myocardial infarction, congestive heart failure ≥ Class 3 based on New York Heart Association Functional Classification or stroke within the past 3 months prior to the scheduled first...
- Active autoimmune disorders within the past 3 years prior to the scheduled first dose of study treatment. The following are exceptions to this criterion:
- people with vitiligo or alopecia.
- people with hypothyroidism (e.g., following Hashimoto syndrome) not requiring systemic treatment or stable on hormone replacement.
- people with psoriasis not requiring systemic treatment.
- Any chronic skin condition that does not require systemic therapy.
- people with celiac disease controlled by diet alone;
- Have known uncontrolled human immunodeficiency virus (HIV)-1/2 infection.
- Participants with HIV (known HIV 1/2 antibodies positive) are allowed if all of the following conditions are met: CD4+ T-cell counts ≥350 cells/uL; no opportunistic infection within the past 12 months; on established...
- History of primary immunodeficiency, solid organ transplantation, or active tuberculosis (by clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line...
- Other invasive malignancy within 2 years. Non-invasive malignancies (i.e., cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that has...
- Known allergy or hypersensitivity to investigational product formulations.
- History of more than one event of infusion related reactions (IRR) requiring permanent discontinuation of IV drug treatment.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring antibiotic therapy, uncontrolled hypertension, bleeding diatheses, or psychiatric illness/social situations that...
- Current or prior use of immunosuppressive medication within 14 days prior to the scheduled first dose of study treatment. The following are exceptions to this criterion:
- Intranasal, topical, inhaled corticosteroids or local steroid injections (e.g., intra articular injection).
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent.
- Steroids as premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication).
- Receipt of live, attenuated vaccine within 30 days prior to the scheduled first dose of study treatment (Note: people, if enrolled, should not receive live vaccine during the study and 180 days after the last dose of...
- Major surgery (as defined by the investigator) within 28 days prior to the scheduled first dose of study treatment or still recovering from prior surgery. Local procedures (e.g., placement of a systemic port, core...
- Females who are pregnant, lactating, or intend to become pregnant during their participation in the study.
- people who are involuntarily incarcerated or are unable to willingly provide consent or are unable to comply with the protocol procedures. Any condition that, in the opinion of the investigator, would interfere with...
- Any condition that, in the opinion of the investigator, would interfere with safe administration or evaluation of the investigational products or interpretation of subject safety or study results.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Nivolumab or other agents used in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.