Trial · NCT07524257
Phase 3 Study of Nogapendekin Alfa Inbakicept Plus Standard of Care vs Standard of Care in First-Line Advanced or Metastatic NSCLC
NCT07524257, Phase 3, Withdrawn, ImmunityBio, Inc.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Phase 3 Study of Nogapendekin Alfa Inbakicept Plus Standard of Care vs Standard of Care in First-Line Advanced or Metastatic NSCLC. Trials, record NCT07524257. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07524257
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Study of Nogapendekin Alfa Inbakicept Plus Standard of Care vs Standard of Care in First-Line Advanced or Metastatic NSCLC
- NCT number
- NCT07524257
- Status
- Withdrawn
- Phases
- Phase 3
- Enrollment
- 0 participants, actual
- Lead sponsor
- ImmunityBio, Inc.
- Conditions
- NSCLC (Advanced Non-small Cell Lung Cancer), Metastatic NSCLC
- Interventions
Drug: Nogapendekin alfa inbakicept (NAI), Pembrolizumab, Cisplatin or Carboplatin, Nab-paclitaxel (squamous) OR Pemetrexed (nonsquamous), Nab-paclitaxel OR Paclitaxel OR Docetaxel (squamous), Pemetrexed (nonsquamous)
- First posted
- 2026-04-13
- Last updated
- 2026-06-22
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) by BICR (RECIST v1.1) | Imaging every 9 weeks (±7 days) from first dose (after initial assessments at week 6 and week 12) until treatment discontinuation; final PFS analysis with follow-up through 156 weeks (3 years) from first dose. | PFS is defined as the time from randomization to the first documentation of disease progression per RECIST v1.1 by blinded independent central review (BICR) or death from any cause, whichever occurs first. |
| Secondary | Overall survival (OS) | From first dose until death, with survival follow-up through 156 weeks (3 years) from first dose. | Time from randomization to death from any cause. |
| Secondary | Objective Response Rate (ORR) by BICR (RECIST v1.1) | Imaging every 9 weeks (±7 days) from first dose (after initial assessments at week 6 and week 12) until treatment discontinuation; ORR assessed up to 156 weeks (3 years) from first dose. | ORR is the proportion of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 by BICR. |
| Secondary | Change in Absolute Lymphocyte Count (ALC) Over Time | At scheduled study visits from first dose through 156 weeks (3 years) from first dose or end of treatment, whichever occurs first. | Change from baseline in absolute lymphocyte count over time by treatment group. |
| Secondary | Duration of Immune Competence (ALC ≥1,000 cells/µL) | From first dose until treatment discontinuation; duration of immune competence assessed up to 156 weeks (3 years) from first dose. | Duration of immune competence, defined as the time during treatment that ALC remains ≥1,000 cells/µL. |
| Secondary | Duration of Response (DOR) by BICR (RECIST v1.1) | Tumor imaging at week 6 and week 12 following Cycle 1 Day 1, then every 9 weeks (±7 days) from first dose until treatment discontinuation; DOR assessed up to 156 weeks (3 years) from first dose. | For participants with a confirmed CR or PR per RECIST v1.1 by BICR, DOR is defined as the time from the date of first documented response (CR or PR) to the date of disease progression per RECIST v1.1 by BICR or death from any cause, whichever occurs first. |
| Secondary | Disease Control Rate (DCR) by BICR (RECIST v1.1) | Tumor imaging at week 6 and week 12 following Cycle 1 Day 1, then every 9 weeks (±7 days) from first dose until treatment discontinuation; DCR assessed up to 156 weeks (3 years) from first dose. | DCR is the proportion of participants with CR, PR, or stable disease (SD) lasting at least 2 months per RECIST v1.1 as assessed by BICR. |
| Secondary | PFS, ORR, DOR, and DCR by BICR Using iRECIST | Tumor imaging at week 6 and week 12 following Cycle 1 Day 1, then every 9 weeks (±7 days) from first dose until treatment discontinuation; each endpoint assessed up to 156 weeks (3 years) from first dose. | PFS, ORR, DOR, and DCR assessed per immune RECIST (iRECIST) as determined by BICR, using the same definitions as for RECIST v1.1 but applying iRECIST rules. |
| Secondary | PFS, ORR, DOR, and DCR by Investigator Assessment (RECIST v1.1 and iRECIST) | Tumor imaging at week 6 and week 12 following Cycle 1 Day 1, then every 9 weeks (±7 days) from first dose until treatment discontinuation; each endpoint assessed up to 156 weeks (3 years) from first dose. | PFS, ORR, DOR, and DCR per RECIST v1.1 and iRECIST as assessed by site Investigators, using the same definitions as for BICR. |
| Secondary | Disease-specific survival (DSS) | From first dose until death due to NSCLC, with follow-up through 156 weeks (3 years) from first dose. | DSS is defined as the time from randomization to death due to NSCLC. Deaths from other causes are censored at the date of death. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT07524257
GET https://conductscience.org/api/trials/v1/NCT07524257/registered