Trial · NCT04914897
A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Lung Cancer or Mesothelioma (Pegathor Lung 202)
NCT04914897, Phase 2, Terminated, Sanofi; results first posted 2025-10-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Lung Cancer or Mesothelioma (Pegathor Lung 202). Trials, record NCT04914897. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04914897
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Lung Cancer or Mesothelioma (Pegathor Lung 202)
- NCT number
- NCT04914897
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 106 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Pleural Mesothelioma, Non-small Cell Lung Cancer
- Interventions
- THOR-707, Pembrolizumab
- First posted
- 2021-06-07
- Last updated
- 2025-10-02
- Other registries' IDs
- eudract:2020-005331-78
- Results first posted
- 2025-10-02
- Limitations and caveats
- The study was terminated based on strategic sponsor decision not driven by any safety concerns.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cohorts A1 and A2: Objective Response Rate (ORR) | From first dose of study treatment administration (Day 1) up to approximately 21 months | ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. CR. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to \<10 millimeter (mm) (\<1 centimeter \[cm\]). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
| Primary | Cohorts B1: Objective Response Rate | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 14 months | ORR was defined as the percentage of participants who had a confirmed CR or PR as per RECIST v1.1. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to \<10 mm (\<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
| Primary | Cohorts C1: Objective Response Rate | From first dose of study treatment administration (Day 1) up to approximately 21 months | ORR was defined as the percentage of participants who had a confirmed CR or PR assessed by the investigator as per modified RECIST (mRECIST) v1.1. CR. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to \<10 mm (\<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | All Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1) | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any AE that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that developed, worsened (according to the investigator's opinion) or became serious during the TE period. |
| Secondary | All Cohorts: Number of Participants With Dose Limiting Toxicities (DLTs) | From Day 1 to Day 21 of Cycle 1 (each cycle is 21 days) | Selected events that occurred during DLT observation period were considered as DLT unless due to PD or to a cause obviously unrelated to pegenzileukin. Selected events included: grade (G) 4 neutropenia for \>=7 consecutive days, G3 or 4 neutropenia complicated by fever or microbiologically or radiographically documented infection, G3 or 4 thrombocytopenia associated with clinically significant bleeding that required clinical intervention; G3 or above alanine aminotransferase or aspartate aminotransferase in combination with a bilirubin \>2 times upper limit of normal with no evidence of cholestasis or another cause such as viral infection or other drugs;G3 or above vascular leak syndrome, hypotension, and cytokine release syndrome;any other G3; G3 or 4 non-hematologic laboratory value; any death not clearly due to the underlying disease or extraneous causes;any toxicity that required permanent discontinuation of the study treatment(s). |
| Secondary | All Cohorts: Time to Response (TTR) | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 27 months (Cohorts A1 and A2), 14 months (Cohort B1), and 24 months (Cohort C1) | TTR was defined as the time from the date of first study treatment administration to the first tumor assessment at which the overall response was recorded as PR or CR that was subsequently confirmed as per RECIST v 1.1 (NSCLC) and assessed by the investigator as per mRECIST v1.1 (mesothelioma). CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to \<10 mm (\<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | All Cohorts: Duration of Response (DOR) | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 27 months (Cohorts A1 and A2), 14 months (Cohort B1), and 24 months (Cohort C1) | DOR was defined as time from date of first tumor assessment at which overall response was recorded as CR or PR that was subsequently confirmed to date of first documentation of objective PD before initiation of any post-treatment anti-cancer therapy or death due to any cause, whichever occurred first, as per RECIST v 1.1 (NSCLS) and assessed by investigator as per mRECIST v1.1 (mesothelioma). CR: disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to \<10 mm (\<1 cm). PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. PD:at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this included baseline sum if that was smallest on study), in addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm (0.5 cm). |
| Secondary | All Cohorts: Clinical Benefit Rate (CBR) | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 27 months (Cohorts A1 and A2), 14 months (Cohort B1), and 24 months (Cohort C1) | The CBR was defined as the percentage of participants with clinical benefit: confirmed CR or PR as best overall response (BOR), or stable disease (SD) that lasted at least 6 months as per RECIST v 1.1 (NSCLS) and assessed by investigator as per mRECIST v1.1 (mesothelioma). CR: disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to \<10 mm (\<1 cm). PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. BOR was the best response observed from start of the study treatment until PD, death, cut-off date or initiation of post-treatment anticancer therapy, whichever occurred first. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Secondary | All Cohorts: Progression Free Survival (PFS) | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 27 months (Cohorts A1 and A2), 14 months (Cohort B1), and 24 months (Cohort C1) | The PFS was defined as the time from the date of first study treatment to the date of the first documentation of objective PD, or death due to any cause, whichever occurred first as per RECIST v 1.1 (NSCLS) and assessed by investigator as per mRECIST v1.1 (mesothelioma). PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm (0.5 cm). |
| Secondary | All Cohorts: Plasma Concentrations of Pegenzileukin | Days 2 and 3 of Cycle 1 (each cycle is 21 days) | Blood samples were collected at specified timepoints for the assessment of plasma concentrations of pegenzileukin. The pharmacokinetic (PK) parameters were calculated using non-compartmental method. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cohorts A1 and A2: Objective Response Rate (ORR) | From first dose of study treatment administration (Day 1) up to approximately 21 months | The efficacy population consisted of all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment. | percentage of participants | NUMBER |
| PRIMARY | Cohorts B1: Objective Response Rate | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 14 months | The efficacy population consisted of all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment. | percentage of participants | NUMBER |
| PRIMARY | Cohorts C1: Objective Response Rate | From first dose of study treatment administration (Day 1) up to approximately 21 months | The efficacy population consisted of all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment. | percentage of participants | NUMBER |
| SECONDARY | All Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1) | The exposed population consisted of all participants who had given their informed consent and received at least one dose of study treatment (pegenzileukin or other anticancer therapies). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | All Cohorts: Number of Participants With Dose Limiting Toxicities (DLTs) | From Day 1 to Day 21 of Cycle 1 (each cycle is 21 days) | The DLT-evaluable population consisted of all exposed participants in the safety run-in who had been observed for at least 21 days. Any participants who had experienced a DLT during DLT observation period were also DLT-evaluable. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | All Cohorts: Time to Response (TTR) | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 27 months (Cohorts A1 and A2), 14 months (Cohort B1), and 24 months (Cohort C1) | The efficacy population consisted of all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment. Only participants with confirmed CR or PR were analyzed. | months | MEAN |
| SECONDARY | All Cohorts: Duration of Response (DOR) | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 27 months (Cohorts A1 and A2), 14 months (Cohort B1), and 24 months (Cohort C1) | The efficacy population consisted of all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment. Only participants with confirmed CR or PR were analyzed. | months | MEDIAN |
| SECONDARY | All Cohorts: Clinical Benefit Rate (CBR) | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 27 months (Cohorts A1 and A2), 14 months (Cohort B1), and 24 months (Cohort C1) | The efficacy population consisted of all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment. | percentage of participants | NUMBER |
| SECONDARY | All Cohorts: Progression Free Survival (PFS) | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 27 months (Cohorts A1 and A2), 14 months (Cohort B1), and 24 months (Cohort C1) | The efficacy population consisted of all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment. | months | MEDIAN |
| SECONDARY | All Cohorts: Plasma Concentrations of Pegenzileukin | Days 2 and 3 of Cycle 1 (each cycle is 21 days) | The PK population consisted of all participants from exposed population with at least one PK concentration available after the first dose of study treatment. Only participants with data collected at specified timepoints are reported. Limited or no participants returned on the Cycle 1 Day 3 for sample collection. | nanogram/milliliter (ng/mL) | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group66
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cohorts A1 and A2: Objective Response Rate (ORR) | Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy | 41.2 | 90% Confidence Interval 21.2 to 63.6 | percentage of participants | |
| Cohorts A1 and A2: Objective Response Rate (ORR) | Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy | 15.0 | 90% Confidence Interval 4.2 to 34.4 | percentage of participants | |
| Cohorts B1: Objective Response Rate | Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy | 2.5 | 90% Confidence Interval 0.1 to 11.3 | percentage of participants | |
| Cohorts C1: Objective Response Rate | Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy | 3.4 | 90% Confidence Interval 0.2 to 15.3 | percentage of participants | |
| All Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy | TEAEs | 16 | Participants | |
| All Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy | TEAEs | 20 | Participants | |
| All Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy | TEAEs | 40 | Participants | |
| All Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy | TEAEs | 29 | Participants | |
| All Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy | TESAEs | 6 | Participants | |
| All Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy | TESAEs | 11 | Participants |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy | 17 | |
| Overall Study | STARTED | Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy | 20 | |
| Overall Study | STARTED | Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy | 40 | |
| Overall Study | STARTED | Cohort C1:Mesothelioma: Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy | 29 | |
| Overall Study | COMPLETED | Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy | 5 | |
| Overall Study | COMPLETED | Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy | 1 | |
| Overall Study | COMPLETED | Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy | 1 | |
| Overall Study | COMPLETED | Cohort C1:Mesothelioma: Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy | 0 | |
| Overall Study | NOT COMPLETED | Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy | 12 | |
| Overall Study | NOT COMPLETED | Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy | 19 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events536
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bronchitis | Infections and infestations | Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy | 1 | 17 | 1 |
| other | Bronchitis | Infections and infestations | Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy | 0 | 20 | 0 |
| other | Bronchitis | Infections and infestations | Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy | 0 | 40 | 0 |
| other | Bronchitis | Infections and infestations | Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy | 0 | 29 | 0 |
| other | Covid-19 | Infections and infestations | Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy | 5 | 17 | 5 |
| other | Covid-19 | Infections and infestations | Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy | 1 | 20 | 1 |
| other | Covid-19 | Infections and infestations | Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy | 7 | 40 | 7 |
| other | Covid-19 | Infections and infestations | Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy | 0 | 29 | 0 |
| other | Cystitis | Infections and infestations | Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy | 1 | 17 | 1 |
| other | Cystitis | Infections and infestations | Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy | 0 | 20 | 0 |
1 to 10 of 536Source ClinicalTrials.gov
See all 536 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy | 3 | 17 |
| Total, all-cause mortality | Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy | 13 | 20 |
| Total, all-cause mortality | Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy | 26 | 40 |
| Total, all-cause mortality | Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy | 18 | 29 |
| Total, other adverse events | Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy | 16 | 17 |
| Total, other adverse events | Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy | 18 | 20 |
| Total, other adverse events | Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy | 38 | 40 |
| Total, other adverse events | Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy | 27 | 29 |
| Total, serious adverse events | Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy | 6 | 17 |
| Total, serious adverse events | Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy | 11 | 20 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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.
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GET https://conductscience.org/api/trials/v1/NCT04914897
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