Non-small Cell Lung Cancer Stage IVPhase 1/2FLINNNCT07355205
First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer
A Phase 1/2 study testing Ipilimumab, Nivolumab and Nogapendekin alfa inbakicept in people with Non-small Cell Lung Cancer Stage IV and Non-small Cell Lung Cancer Recurrent, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Stage IV, Non-small Cell Lung Cancer Recurrent
- What is being tested?
- Ipilimumab, Nivolumab and Nogapendekin alfa inbakicept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2026to 31 Jul 2032
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- Mixed histology including small cell lung cancer.
- Tumor harboring any of the following:
- classic EGFR mutations
- HER2 mutation
- ALK fusion
- ROS1 fusion
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Giordano Fabricio Cittolin Santos, MD, PhD, 314-273-4731, cgiordano@wustl.edu
Giordano Fabricio Cittolin Santos, MD, PhD
About this study
Official title: A Phase Ib/II, Single-Center, Open-Label Study of First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer (FLINN)
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.
- Being tested
- Ipilimumab, Nivolumab, Nogapendekin alfa inbakicept
- Keywords
- Non-small cell lung cancer, Stage IV, Immunotherapy, IL-15 super agnoist
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabDrug
Also called Yervoy
Ipilimumab will be given intravenously at a dose of 1mg/kg.
NivolumabDrug
Also called Opdivo
Nivolumab will be given intravenously at a dose of 360mg.
Nogapendekin alfa inbakiceptDrug
Also called N-803, Anktiva
Nogapendekin alfa inbakicept will be given subcutaneously at the assigned dose level.
| Study group | Role | What they receive |
|---|---|---|
| Phase Ib Dose Level 1: Ipilimumab plus Nivolumab and Nogapendekin alfa inbakicept (N-803) | Experimental | Consenting and eligible patients will receive nivolumab intravenously (IV) on Days 1 and 22, ipilimumab IV on Day 1, and the assigned dose of nogapendekin alfa inbakicept subcutaneously (SC) on Days 1 and 22 of each cycle for Cycles 1 through 4; ipilimumab will be discontinued after Cycle 4 and patients will continue to receive nivolumab and nogapendekin alfa inbakicept on the same schedule for up to 2 years. Cycles are 42 days (6 weeks). Receives: Drug: Ipilimumab; Drug: Nivolumab; Drug: Nogapendekin alfa inbakicept |
| Phase Ib Dose Level -1: Ipilimumab plus Nivolumab and Nogapendekin alfa inbakicept (N-803) | Experimental | Consenting and eligible patients will receive nivolumab intravenously (IV) on Days 1 and 22, ipilimumab IV on Day 1, and the assigned dose of nogapendekin alfa inbakicept subcutaneously (SC) on Days 1 and 22 of each cycle for Cycles 1 through 4; ipilimumab will be discontinued after Cycle 4 and patients will continue to receive nivolumab and nogapendekin alfa inbakicept on the same schedule for up to 2 years. Cycles are 42 days (6 weeks). Receives: Drug: Ipilimumab; Drug: Nivolumab; Drug: Nogapendekin alfa inbakicept |
| Phase II: Ipilimumab plus Nivolumab and Nogapendekin alfa inbakicept (N-803) | Experimental | Consenting and eligible patients will receive nivolumab intravenously (IV) on Days 1 and 22, ipilimumab IV on Day 1, and the assigned dose of nogapendekin alfa inbakicept subcutaneously (SC) on Days 1 and 22 of each cycle for Cycles 1 through 4; ipilimumab will be discontinued after Cycle 4 and patients will continue to receive nivolumab and nogapendekin alfa inbakicept on the same schedule for up to 2 years. Cycles are 42 days (6 weeks). Receives: Drug: Ipilimumab; Drug: Nivolumab; Drug: Nogapendekin alfa inbakicept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) (Phase Ib acceptable dose participants and Phase II participants)
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.
Measured: Start of treatment through 2 years after end of treatment (up to 4 years)
Incidence of dose-limiting toxicities (DLTs) (Phase Ib participants)
DLTs are defined in the protocol.
Measured: From start of treatment through completion of cycle 1 (each cycle is 42 days)
Secondary outcomes (7)
Adverse event effect rate (All participants)
Defined as the number of study treatment related adverse events (AEs) and discontinuations due to treatment-related AEs. Adverse events will be assessed using the CTCAE v5.0 criteria.
Measured: Start of treatment through 100 days after discontinuation of therapy (up to 2 years and 100 days)
Disease control rate (DCR) (Phase Ib acceptable dose participants and Phase II participants)
DCR is defined as the proportion of patients achieving either a complete response (CR), partial response (PR), or stable disease (SD), according to RECIST 1.1.
Complete Response (CR): Disappearance of all target lesions. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis).
Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
Measured: Start of treatment through 2 years after end of treatment (up to 4 years)
Duration of response (DoR) (Phase Ib acceptable dose participants and Phase II participants) (Phase Ib acceptable dose participants and Phase II participants)
DoR is defined as the time from the confirmation of a CR of PR according to RECIST 1.1 until the first date that recurrent or progressive disease is objectively documented or death from any cause.
Complete Response (CR): Disappearance of all target lesions. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis).
Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Start of treatment through 2 years after end of treatment (up to 4 years)
Objective response rate (ORR) (Phase Ib acceptable dose participants and Phase II participants)
ORR is defined as the proportion of patients achieving CR or PR measured according to RECIST 1.1.
Complete Response (CR): Disappearance of all target lesions. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis).
Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Start of treatment through completion of treatment or progression (up to 2 years)
Immune-related best overall response (iBOR) (Phase Ib acceptable dose participants and Phase II participants)
iBOR is defined as the proportion of the best confirmed immune-related response recorded from the start of the study treatment until disease progression, the end of treatment, or death, whichever comes first, according to iRECIST guideline.
Measured: Start of study treatment to up to 2 years after the end of treatment (up to 4 years)
Immune-related progression-free survival (iPFS) (Phase Ib acceptable dose participants and Phase II participants)
iPFS is defined as the time from the start date of study treatment to date of confirmed immune-related progressive disease by investigator's assessment or death from any cause, whichever occurs first.
Immune unconfirmed progressive disease (iUPD) is defined according to iRECIST guidelines.
Measured: Start of study treatment up to 2 years after treatment is completed (up to 4 years)
Overall survival (OS) (Phase Ib acceptable dose participants and Phase II participants)
OS is defined as the duration of time from the start date of study treatment to death from any cause.
Measured: Start of study treatment up to 2 years after treatment is completed (total 4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start7 Jul 2026
- Primary completion31 Jul 2032 (estimated)
- Study completion31 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer Stage IVStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- ImmunityBio, Inc., The Foundation for Barnes-Jewish Hospital
- Responsible party
- Sponsor
- Investigators
- Giordano Fabricio Cittolin Santos, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355205
- Sponsor's protocol ID
- 202602160
- Acronym
- FLINN
- Status last verified
- Jul 2026
- First submitted
- 19 Jan 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II, Single-Center, Open-Label Study of First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer (FLINN)
- ClinicalTrials.gov ID
- NCT07355205
- Acronym / sponsor ID
- FLINN / 202602160
- Keywords
- Non-small cell lung cancer, Stage IV, Immunotherapy, IL-15 super agnoist
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- ImmunityBio, Inc., The Foundation for Barnes-Jewish Hospital
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- 31 Jul 2032 (estimated)
- Study completion
- 31 Jul 2032 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase Ib Dose Level 1: Ipilimumab plus Nivolumab and Nogapendekin alfa inbakicept (N-803) | Experimental | Drug: Ipilimumab, Drug: Nivolumab, Drug: Nogapendekin alfa inbakiceptConsenting and eligible patients will receive nivolumab intravenously (IV) on Days 1 and 22, ipilimumab IV on Day 1, and the assigned dose of nogapendekin alfa inbakicept subcutaneously (SC) on Days 1 and 22 of each cycle for Cycles 1 through 4; ipilimumab will be discontinued after Cycle 4 and patients will continue to receive nivolumab and nogapendekin alfa inbakicept on the same schedule for up to 2 years. Cycles are 42 days (6 weeks). |
| Phase Ib Dose Level -1: Ipilimumab plus Nivolumab and Nogapendekin alfa inbakicept (N-803) | Experimental | Drug: Ipilimumab, Drug: Nivolumab, Drug: Nogapendekin alfa inbakiceptConsenting and eligible patients will receive nivolumab intravenously (IV) on Days 1 and 22, ipilimumab IV on Day 1, and the assigned dose of nogapendekin alfa inbakicept subcutaneously (SC) on Days 1 and 22 of each cycle for Cycles 1 through 4; ipilimumab will be discontinued after Cycle 4 and patients will continue to receive nivolumab and nogapendekin alfa inbakicept on the same schedule for up to 2 years. Cycles are 42 days (6 weeks). |
| Phase II: Ipilimumab plus Nivolumab and Nogapendekin alfa inbakicept (N-803) | Experimental | Drug: Ipilimumab, Drug: Nivolumab, Drug: Nogapendekin alfa inbakiceptConsenting and eligible patients will receive nivolumab intravenously (IV) on Days 1 and 22, ipilimumab IV on Day 1, and the assigned dose of nogapendekin alfa inbakicept subcutaneously (SC) on Days 1 and 22 of each cycle for Cycles 1 through 4; ipilimumab will be discontinued after Cycle 4 and patients will continue to receive nivolumab and nogapendekin alfa inbakicept on the same schedule for up to 2 years. Cycles are 42 days (6 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (33 listed)
- Mixed histology including small cell lung cancer.
- Tumor harboring any of the following:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IpilimumabAlso: YervoyIpilimumab will be given intravenously at a dose of 1mg/kg. | Drug | Phase II: Ipilimumab plus Nivolumab and Nogapendekin alfa inbakicept (N-803), Phase Ib Dose Level -1: Ipilimumab plus Nivolumab and Nogapendekin alfa inbakicept (N-803), Phase Ib Dose Level 1: Ipilimumab plus Nivolumab and Nogapendekin alfa inbakicept (N-803) |
| NivolumabAlso: OpdivoNivolumab will be given intravenously at a dose of 360mg. | Drug | Phase II: Ipilimumab plus Nivolumab and Nogapendekin alfa inbakicept (N-803), Phase Ib Dose Level -1: Ipilimumab plus Nivolumab and Nogapendekin alfa inbakicept (N-803), Phase Ib Dose Level 1: Ipilimumab plus Nivolumab and Nogapendekin alfa inbakicept (N-803) |
| Nogapendekin alfa inbakiceptAlso: N-803, AnktivaNogapendekin alfa inbakicept will be given subcutaneously at the assigned dose level. | Drug | Phase II: Ipilimumab plus Nivolumab and Nogapendekin alfa inbakicept (N-803), Phase Ib Dose Level -1: Ipilimumab plus Nivolumab and Nogapendekin alfa inbakicept (N-803), Phase Ib Dose Level 1: Ipilimumab plus Nivolumab and Nogapendekin alfa inbakicept (N-803) |
Primary outcome
Progression-free survival (PFS) (Phase Ib acceptable dose participants and Phase II participants)
Time frame: 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)
Time frame: From start of treatment through completion of cycle 1 (each cycle is 42 days)
DLTs are defined in the protocol.
7 secondary outcomes
Adverse event effect rate (All participants)
Time frame: Start of treatment through 100 days after discontinuation of therapy (up to 2 years and 100 days)
Disease control rate (DCR) (Phase Ib acceptable dose participants and Phase II participants)
Time frame: Start of treatment through 2 years after end of treatment (up to 4 years)
Duration of response (DoR) (Phase Ib acceptable dose participants and Phase II participants) (Phase Ib acceptable dose participants and Phase II participants)
Time frame: Start of treatment through 2 years after end of treatment (up to 4 years)
Objective response rate (ORR) (Phase Ib acceptable dose participants and Phase II participants)
Time frame: Start of treatment through completion of treatment or progression (up to 2 years)
Immune-related best overall response (iBOR) (Phase Ib acceptable dose participants and Phase II participants)
Time frame: Start of study treatment to up to 2 years after the end of treatment (up to 4 years)
Immune-related progression-free survival (iPFS) (Phase Ib acceptable dose participants and Phase II participants)
Time frame: Start of study treatment up to 2 years after treatment is completed (up to 4 years)
Overall survival (OS) (Phase Ib acceptable dose participants and Phase II participants)
Time frame: Start of study treatment up to 2 years after treatment is completed (total 4 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giordano Fabricio Cittolin Santos, MD, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ipilimumab, Nivolumab and Nogapendekin alfa inbakicept in people with Non-small Cell Lung Cancer Stage IV and Non-small Cell Lung Cancer Recurrent, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giordano Fabricio Cittolin Santos, MD, PhD (314-273-4731, cgiordano@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (Phase Ib acceptable dose participants and Phase II participants) (time frame: Start of treatment through 2 years after end of treatment (up to 4 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.