Trial · NCT07234058
Trial Assessing Fianlimab Plus Cemiplimab Plus Chemotherapy or Cemiplimab Plus Chemotherapy in Patients With Pleural Mesothelioma
NCT07234058, Phase 2, Recruiting, Intergroupe Francophone de Cancerologie Thoracique
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial Assessing Fianlimab Plus Cemiplimab Plus Chemotherapy or Cemiplimab Plus Chemotherapy in Patients With Pleural Mesothelioma. Trials, record NCT07234058. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07234058
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial Assessing Fianlimab Plus Cemiplimab Plus Chemotherapy or Cemiplimab Plus Chemotherapy in Patients With Pleural Mesothelioma
- NCT number
- NCT07234058
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 126 participants, estimated
- Lead sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Conditions
- Pleural Mesotheliomas
- Interventions
- Cemiplimab, Fianlimab, Pemetrexed (Alimta), Cisplatin, Carboplatin (AUC 5)
- First posted
- 2025-11-18
- Last updated
- 2026-08-11
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To evaluate the activity of the combination of double immunotherapy anti-LAG3+ anti-PD-1 and pemetrexed+platinum chemotherapy | 6 months after randomisation. | The primary endpoint is 6-month disease control rate (DCR). The analysis will be conducted in the FAS population. DCR is defined as the proportion of patients who have achieved at 6 months an overall response of CR, PR or stable disease (SD), as assessed by an independant review committee (IRC) per RECIST v1.1 modified for mesothelioma. |
| Secondary | Tolerance, safety of treatment | From time of informed consent through treatment period and up to 90 days post last dose of study treatment (maximum of 2 years and 3 months). | Incidence, nature, and severity of adverse events (AE), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0). The rate of Hyper-Progressive Disease (HPD) will also be calculated. |
| Secondary | Progression Free Survival (PFS) as assessed by an IRC | At progression, up to 2 years after start of treatment. | PFS is defined as the time between the date of randomisation and the first date of documented progression, as assessed by investigator and an IRC per RECIST v1.1 modified for mesothelioma, or death due to any cause, whichever occurs first. |
| Secondary | PFS as assessed by the investigator | At progression, up to 2 years after start of treatment. | PFS is defined as the time between the date of randomisation and the first date of documented progression, as assessed by investigator and an IRC per RECIST v1.1 modified for mesothelioma, or death due to any cause, whichever occurs first. |
| Secondary | PFS according to the histological subtype epithelioid vs. non-epithelioid | At progression, up to 2 years after start of treatment. | PFS is defined as the time between the date of randomisation and the first date of documented progression, as assessed by investigator and an IRC per RECIST v1.1 modified for mesothelioma, or death due to any cause, whichever occurs first. PFS will be analysed according to the histological subtype. |
| Secondary | Overall Survival (OS) | Around 42 months. | OS is defined as the time from date of randomisation to the date of death due to any cause. If a death has not been observed by the date of the analysis cut-off, OS will be censored at the date of last contact. |
| Secondary | Best Overall Response Rate (ORR) | At progression, up to 2 years after start of treatment. | ORR is defined as the proportion of patients who have achieved a best overall response of complete response (CR) or partial response (PR) as determined by investigator review of radiographic disease assessments per RECIST v1.1 modified for mesothelioma. |
| Secondary | Time until definitive HRQol score deterioration | At progression, up to 2 years after start of treatment. | Time until definitive HRQol score deterioration will be measured using LCSS-meso questionnaire. |
| Secondary | General health status | At progression, up to 2 years after start of treatment. | General health status will be measured using the EQ-5D-5L questionnaire. |
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/NCT07234058
GET https://conductscience.org/api/trials/v1/NCT07234058/registered