Study of Ipilimumab, Nivolumab, and Nogapendekin Alfa Inbakicept for Stage IV or Recurrent Lung Cancer
This study is looking at a new combination of treatments for people with advanced (Stage IV) or recurrent non-small cell lung cancer (NSCLC). It combines three drugs: Ipilimumab, Nivolumab, and Nogapendekin alfa inbakicept. Ipilimumab and Nivolumab work by boosting your body's immune system to fight cancer. Researchers want to see if adding Nogapendekin alfa inbakicept will make these two drugs work even better. The study will enroll about 26 participants. Success will be measured by how long people live without their cancer growing (progression-free survival) and by looking at any side effects. To join, you need to have NSCLC that has spread or come back, and your cancer must be measurable. You'll also need a biopsy for biomarker analysis, though the results won't prevent you from joining. The current recruitment status is unclear.
- Study design
- This is a single-center study, meaning it takes place at one location. It's a Phase Ib/II study, which means it's an early-stage trial looking at safety and effectiveness, and plans to enroll about 26 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for progression-free survival from the start of treatment through 2 years after the end of treatment, which could be up to 4 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07355205
First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentWashington University School of MedicineInvestigator-initiated
~26 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:IpilimumabNivolumabNogapendekin alfa inbakicept
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS) (Phase Ib acceptable dose participants and Phase II participants)
Measured over Start of treatment through 2 years after end of treatment (up to 4 years)
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMissouri1
Study leadership
- Giordano Fabricio Cittolin Santos, MD, PhD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 enrollment.
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 at dose higher than 10 mg of prednisone or equivalent on C1D1.
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 contraception, according to the protocol, from the time of consent through 6 months after the last dose of study treatment.
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.
Exclusion
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 patient is eligible.
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 excluded).
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 months are eligible. HIV testing not required in the absence of known history of infection.
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 required in the absence of known history of infection.
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 currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.
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 immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy.
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 efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.
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 trial formulations.
Pregnant and/or breastfeeding. People of childbearing potential must have a negative pregnancy test within 7 days of study entry.
What this trial measures
- Progression-free survival (PFS) (Phase Ib acceptable dose participants and Phase II participants)Start of treatment through 2 years after end of treatment (up to 4 years)
PFS is defined as the duration of time from the start date of study treatment to the date of earliest progression or death, whichever occurs first. Patients who neither progress nor die by the data cutoff date will be censored at the last follow up date.
- Incidence of dose-limiting toxicities (DLTs) (Phase Ib participants)From start of treatment through completion of cycle 1 (each cycle is 42 days)
DLTs are defined in the protocol.