Trial · NCT07355205
First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer
NCT07355205, Phase 1, Phase 2, Recruiting, Washington University School of Medicine
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer. Trials, record NCT07355205. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07355205
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer
- NCT number
- NCT07355205
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 26 participants, estimated
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Non-small Cell Lung Cancer Stage IV, Non-small Cell Lung Cancer Recurrent
- Interventions
- Ipilimumab, Nivolumab, Nogapendekin alfa inbakicept
- First posted
- 2026-01-21
- Last updated
- 2026-07-10
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Secondary | Adverse event effect rate (All participants) | Start of treatment through 100 days after discontinuation of therapy (up to 2 years and 100 days) | 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. |
| Secondary | Disease control rate (DCR) (Phase Ib acceptable dose participants and Phase II participants) | Start of treatment through 2 years after end of treatment (up to 4 years) | 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. |
| Secondary | Duration of response (DoR) (Phase Ib acceptable dose participants and Phase II participants) (Phase Ib acceptable dose participants and Phase II participants) | Start of treatment through 2 years after end of treatment (up to 4 years) | 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. |
| Secondary | Objective response rate (ORR) (Phase Ib acceptable dose participants and Phase II participants) | Start of treatment through completion of treatment or progression (up to 2 years) | 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. |
| Secondary | Immune-related best overall response (iBOR) (Phase Ib acceptable dose participants and Phase II participants) | Start of study treatment to up to 2 years after the end of treatment (up to 4 years) | 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. |
| Secondary | Immune-related progression-free survival (iPFS) (Phase Ib acceptable dose participants and Phase II participants) | Start of study treatment up to 2 years after treatment is completed (up to 4 years) | 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. |
| Secondary | Overall survival (OS) (Phase Ib acceptable dose participants and Phase II participants) | Start of study treatment up to 2 years after treatment is completed (total 4 years) | OS is defined as the duration of time from the start date of study treatment to death from any cause. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07355205
GET https://conductscience.org/api/trials/v1/NCT07355205/registered