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New treatment option for Carcinoma, Non-Small-Cell Lung
Official title Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy
ClinicalTrials.gov ID: NCT05715229
What this study is testing
What is Nivolumab?
Nivolumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for carcinoma, non-small-cell lung.
Also referred to as Opdivo.
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 clinical trial plans to assess to what extent the on-treatment circulating tumor DNA (ctDNA) can predict the subset of patients with NSCLC who will respond to immunotherapy treatment only and which patients will need both immunotherapy and chemotherapy modalities for their treatment regimen.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Eligible patients will have newly diagnosed, previously untreated histologically documented Stage IV NSCLC
- Eligible patients will be required to have positive PD-L1 expression ≥1% by IHC using Dako 22C3 assay.
- Patients will require a baseline Guardant360 CDx test prior to enrollment
- Patients willing to undergo serial ctDNA testing as required by protocol
- Patients will be over the age of 18
You likely can't join if
- Patients under the age of 18
- Inability to provide informed consent by either the patient or the authorized representative
- Patients with known EGFR, ALK, ROS1, MET, and RET oncogenic driver alterations that have approved first-line targeted therapies are excluded from the...
- Patients with no detectable ctDNA or ctDNA VAF ≤ 0.3% on Guardant360 CDx at baseline
- people with untreated CNS metastases are excluded.
- people are eligible if CNS metastases are adequately treated and people are neurologically returned to baseline (except for residual signs or...
See the full eligibility criteria
- Eligible patients will have newly diagnosed, previously untreated histologically documented Stage IV NSCLC
- Eligible patients will be required to have positive PD-L1 expression ≥1% by IHC using Dako 22C3 assay.
- Patients will require a baseline Guardant360 CDx test prior to enrollment
- Patients willing to undergo serial ctDNA testing as required by protocol
- Patients will be over the age of 18
- Life expectancy ≥12 weeks
- Measurable (RECIST 1.1) indicator lesion not previously irradiated, with measurable disease determined per the treating investigator.
- Prior palliative radiotherapy to non-CNS lesions must have been completed at least 2 weeks prior to randomization
- ECOG Performance Score ≤2
- Adequate organ function
- Hemoglobin \> 9 g/dL
- Platelets \> 100,000mm3 or 100 x 109/L
- AST, ALT \< 2.5 x ULN with no liver metastases or \< 5x ULN with the presence of liver metastases
- Total bilirubin \< 1.5 x ULN if no liver metastases or \< 3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases
- Absolute neutrophil count (ANC) \> 1500 cells/mm3
- Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 60ml/min calculated by Cockcroft and Gault's equation
- Willing to use highly effective contraceptive measures if child-bearing potential or if the patient's sexual partner is a woman of childbearing potential: a. Female people should be using a highly effective...
- Patients under the age of 18
- Inability to provide informed consent by either the patient or the authorized representative
- Patients with known EGFR, ALK, ROS1, MET, and RET oncogenic driver alterations that have approved first-line targeted therapies are excluded from the study (All patients must have a tissue or blood-based testing to...
- Patients with no detectable ctDNA or ctDNA VAF ≤ 0.3% on Guardant360 CDx at baseline
- people with untreated CNS metastases are excluded.
- people are eligible if CNS metastases are adequately treated and people are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to...
- people with carcinomatous meningitis
- people must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before randomization
- people with previous malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission...
- Other active malignancy requiring concurrent intervention.
- people with an active, known, or suspected autoimmune disease. people with type I diabetes mellitus, and hypothyroidism only require hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not...
- people with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical...
- people with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.
- Significant uncontrolled cardiovascular disease, including but not limited to, any of the following:
- Uncontrolled hypertension, which is defined as systolic blood pressure \> 160 mm Hg or diastolic blood pressure \> 100 mm Hg despite optimal medical management.
- Active coronary artery disease, including unstable all newly diagnosed angina within 3 months of study enrollment.
- Myocardial infarction in the past 6 months.
- History of congenital long QT syndrome.
- History of clinically significant arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or torsade de pointes.
- Uncontrolled heart failure, defined as class III of 4 by the New York Heart Association functional classification.
- History of a current diagnosis of myocarditis.
- the Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results.
- Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
- people with Grade 2 peripheral neuropathy
- Life expectancy \<12 weeks
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Hackensack, New Jersey, United States
- Neptune City, New Jersey, United States
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 Washington D.C., District of Columbia, United States; Hackensack, New Jersey, United States; Neptune City, New Jersey, United States. 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.