Trial · NCT07509099
Cetuximab Combined With Pembrolizumab or Finotonlimab and Chemotherapy in R/M HNSCC
NCT07509099, Phase 3, Recruiting, Ji Dongmei
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Cetuximab Combined With Pembrolizumab or Finotonlimab and Chemotherapy in R/M HNSCC. Trials, record NCT07509099. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07509099
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cetuximab Combined With Pembrolizumab or Finotonlimab and Chemotherapy in R/M HNSCC
- NCT number
- NCT07509099
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 316 participants, estimated
- Lead sponsor
- Ji Dongmei
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Interventions
- cetuximab+PD-1 mAb(Pembrolizumab/Finotonlimab)+chemotherapy, PD-1 mAb (Pembrolizumab/Finotonlimab) + chemothearpy
- First posted
- 2026-04-03
- Last updated
- 2026-10-02
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Expected 51 months following the First Subject First Visit (FSFV) | PFS assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 |
| Secondary | Objective Response Rate (ORR) | Expected 51 months following the First Subject First Visit (FSFV) | Disease Control Rate (DCR), Duration of Response (DoR), Time to Response (TTR), Overall Survival (OS) |
| Secondary | Disease Control Rate (DCR) | Expected 51 months following the First Subject First Visit (FSFV) | The disease control rate (DCR) is defined as the proportion of subjects in the full analysis set (FAS) whose best overall response is either complete response (CR), partial response (PR), or stable disease (SD) based on investigator assessment using RECIST v1.1. Subjects with SD must have maintained SD for at least 6 weeks from the first dose to be counted as disease control. |
| Secondary | Duration of Response (DoR) | Expected 51 months following the First Subject First Visit (FSFV) | The time from the first documented evidence of objective response (CR or PR) to the first documented disease progression or death from any cause, whichever occurred first. |
| Secondary | Time to Response (TTR) | Expected 51 months following the First Subject First Visit (FSFV) | The time from the date of randomization to the date of the first documented objective response (complete response \[CR\] or partial response \[PR\]) in patients who ultimately achieve a response. |
| Secondary | Overall Survival (OS) | Expected 51 months following the First Subject First Visit (FSFV) | The time from randomization to death from any cause. |
| Secondary | Safety Endpoints | Expected 51 months following the First Subject First Visit (FSFV) | Incidence and severity of adverse events (AEs) and serious adverse events (SAE), including abnormalities in vital signs, electrocardiograms, and laboratory tests. |
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.
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/NCT07509099
GET https://conductscience.org/api/trials/v1/NCT07509099/registered