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New treatment option for Non-small Cell Lung Cancer Stage IV
Official title First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT07355205
What this study is testing
What is Ipilimumab?
Ipilimumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer stage iv.
Also referred to as Yervoy.
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 single center, phase Ib/II study combining an anti-PD-1 antibody and an anti-CTLA-4 antibody with IL-15. It is testing the hypothesis that the addition of nogapendekin alfa inbakicept to nivolumab and ipilimumab will augment the clinical activity of those two drugs.
- 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
- Histologically or cytologically confirmed, previously untreated or recurrent metastatic NSCLC.
- Availability of archival biopsy tissue or willingness to undergo a biopsy prior to C1D1 for biomarker analysis, including PD-L1 by IHC using a...
- Measurable disease per RECIST 1.1.
- At least 18 years of age.
- ECOG performance status ≤ 1
You likely can't join if
- Mixed histology including small cell lung cancer.
- Tumor harboring any of the following:
- classic EGFR mutations
- HER2 mutation
- ALK fusion
- ROS1 fusion
See the full eligibility criteria
- Histologically or cytologically confirmed, previously untreated or recurrent metastatic NSCLC.
- Availability of archival biopsy tissue or willingness to undergo a biopsy prior to C1D1 for biomarker analysis, including PD-L1 by IHC using a CLIA-certified test. Results of the PD-L1 testing are not required for...
- Measurable disease per RECIST 1.1.
- At least 18 years of age.
- ECOG performance status ≤ 1
- Adequate organ and marrow function, as defined below:
- Absolute neutrophil count ≥ 1.5 K/cumm
- Platelets ≥ 100 K/cumm
- Hemoglobin ≥ 9.0 g/dL
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN without hepatic metastasis and ≤ 5 x IULN with hepatic metastasis
- Total bilirubin ≤ 2 x IULN (except participants with Gilbert's syndrome who must have total bilirubin \< 3.0 mg/dL)
- Creatinine clearance \> 30 mL/min by Cockcroft-Gault
- INR ≤ 1.5 unless using therapeutic anticoagulation
- PTT/aPTT \< 1.5 x IULN unless using therapeutic anticoagulation
- Patients with brain metastases are eligible if they have previously treated with surgery or radiation therapy, are neurologically stable after a washout period of at least 2 weeks, and are not receiving corticosteroids...
- The effects of the treatment regimen on the developing human fetus are unknown. For this reason, people of childbearing potential and people able to father a child must agree to use highly effective methods of...
- Ability to understand and willingness to sign an IRB-approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
- Mixed histology including small cell lung cancer.
- Tumor harboring any of the following:
- classic EGFR mutations
- HER2 mutation
- ALK fusion
- ROS1 fusion
- RET fusion
- NTRK fusion
- MET Exon14 skipping mutation
- BRAF V600E mutation
- Use of any live vaccines within 28 days of C1D1.
- Prior chemotherapy in the adjuvant setting or during concurrent radiation therapy for locally advanced disease within 12 months prior to enrollment. If the interval from the last treatment is 12 months or longer, the...
- Radiation therapy within 14 days prior to C1D1.
- History of major surgery within 14 days prior to C1D1.
- Underlying medical conditions that, in the Investigator's opinion, will make the administration of study treatment hazardous, including but not limited to:
- History of interstitial lung disease or noninfectious pneumonitis,
- Active viral, bacterial or fungal infections requiring parenteral treatment within 14 days of C1D1,
- Clinically significant cardiovascular disease,
- A condition that may obscure the interpretation of toxicity determination or AEs,
- History of prior solid-organ transplantation.
- Concurrent medical condition requiring the use of supra-physiologic doses of corticosteroids (\> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications (absorbable topical corticosteroids are not...
- HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving anti-retroviral therapy and have had an undetectable viral load for at least 6...
- Evidence of chronic hepatitis B (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not...
- History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are...
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or...
- Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
- Participants with asthma who require intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections will not be excluded from this study.
- Participants on chronic systemic corticosteroids will be excluded from the study.
- Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or how well it works assessment of the investigational regimen. Patients with prior or concurrent malignancy that does...
- Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of C1D1.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in the study, or known hypersensitivity to recombinant proteins, or any excipient contained in the...
- Pregnant and/or breastfeeding. People of childbearing potential must have a negative pregnancy test within 7 days of study entry.
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, 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 St Louis, Missouri, 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.