Trial · NCT07418931
A Multicenter Open-label Phase II Study of Cemiplimab Plus Chemotherapy, Selected on the Basis of Baseline Cytidine Deaminase Activity, in Advanced Squamous Non-small Cell Lung Cancer
NCT07418931, Phase 2, Not yet recruiting, Gruppo Oncologico Italiano di Ricerca Clinica
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Multicenter Open-label Phase II Study of Cemiplimab Plus Chemotherapy, Selected on the Basis of Baseline Cytidine Deaminase Activity, in Advanced Squamous Non-small Cell Lung Cancer. Trials, record NCT07418931. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07418931
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multicenter Open-label Phase II Study of Cemiplimab Plus Chemotherapy, Selected on the Basis of Baseline Cytidine Deaminase Activity, in Advanced Squamous Non-small Cell Lung Cancer
- NCT number
- NCT07418931
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 108 participants, estimated
- Lead sponsor
- Gruppo Oncologico Italiano di Ricerca Clinica
- Conditions
- Advanced Squamous Non-Small Cell Lung Cancer
- Interventions
- Cemiplimab 350 mg IV, Paclitaxel 200 mg/sqm IV, Carboplatin AUC 5 IVa, Cisplatin 80 mg/sqm IV, Gemcitabine 1000 mg/sqm a, Carboplatin AUC 6 IVb, Gemcitabine 1200 mg/sqm b
- First posted
- 2026-02-18
- Last updated
- 2026-02-18
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The primary endpoint is the Overall Survival (OS) | Four years | The OS will be measured from the date of registration to the date of death by any cause and will be analyzed as survival rate at 1 year. |
| Secondary | Secondary outcomes | Four years | Median OS that will be measured from the date of registration to the date of death by any cause. |
| Secondary | Secondary Outcome | Three and five years | Survival rate at 3 year and 5 years will be analysed |
| Secondary | Secondary Outcome | Four years | Progression Free Survival (PFS) that will be measured from the date of registration to the date of disease progression |
| Secondary | Secondary Outcome | Four years | Objective Response Rate (ORR) that will be defined as the sum of complete response (CR)+ partial response (PR), based on the Investigator's assessment according to standard RECIST 1.1 criteria. Patients with no tumor assessment after baseline will be classified as non-responders. |
| Secondary | Secondary Outcome | Four years | Median Duration of Response (DoR) that will be measured from the date of first radiological evidence PR or CR to the date of first evidence of PD, both based on the Investigator's assessment according to standard RECIST 1.1 criteria. Patients with no tumor assessment after baseline will be classified as non-responders |
| Secondary | Secondary Outcome | Four Years | Time to tumor response (TTR) that will be defined as the time from the start of treatment to the first objective of tumor response. |
| Secondary | Secondary Outcome | Four Years | Disease control rate (DCR) that will be defined as the sum of complete response (CR) + partial response (PR) + stable disease (SD), based on the Investigator's assessment according to standard RECIST 1.1 criteria |
| Secondary | Secondary Outcome | Four Years | OS, PFS and ORR will be analysed by PD-L1 levels: \< 1%; 1- 49%, ≥ 50%. |
| Secondary | Secondary Outcome | Four Years | Toxicity that will be based mainly on the frequency and severity of adverse events (all grades and grade 3-4); severity will be measured according to NCI Common terminology Criteria Adverse Event (CTCAE), version 5.0. The worst severity grade adverse event will be considered for each patient. |
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/NCT07418931
GET https://conductscience.org/api/trials/v1/NCT07418931/registered