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A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Lung Cancer or Mesothelioma (Pegathor Lung 202)

Primary Purpose

Pleural Mesothelioma, Non-small Cell Lung Cancer

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
THOR-707
Pembrolizumab
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pleural Mesothelioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participant must be ≥18 years of age (or country's legal age of majority if >18 years), at the time of signing the informed consent.
  • Histologically or cytologically confirmed diagnosis of Stage IV NSCLC (cohorts A1, A2, and B1), or unresectable malignant pleural mesothelioma (cohort C1).
  • Cohort A1: PD-L1 expression TPS ≥ 50%
  • Cohort A2: PD-L1 expression TPS 1 - 49%
  • Prior anticancer therapy
  • Cohorts A1 and A2: No prior systemic therapy for advanced/metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the development of metastatic disease.
  • Cohort B1: One prior anti-PD1/PD-L1 regimen (may include chemotherapy) plus one additional chemotherapy regimen
  • Cohort C1: One or two prior systemic treatments that include pemetrexed-based regimen in combination with platinum agent.
  • All cohorts must have a measurable disease
  • Mandatory baseline biopsy for the first 20 participants to enroll in cohorts A1, A2
  • Cohort B1: Based on the Investigator's judgment, either docetaxel or pemetrexed is not the best treatment option for the participant.
  • Females are eligible to participate if they are not pregnant or breastfeeding, not a woman of childbearing potential (WOCBP) or are a WOCBP that agrees:

    • to use approved contraception method and submit to regular pregnancy testing prior to treatment and for 150 days after discontinuing study treatment
    • to refrain from donating or cryopreserving eggs for 150 days after discontinuing study treatment.
  • Males are eligible to participate if they agree to refrain from donating or cryopreserving sperm, and either abstain from heterosexual intercourse OR use approved contraception during study treatment and for at least 210 days after discontinuing study treatment.
  • Capable of giving signed informed consent.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 2.
  • Poor bone marrow reserve
  • Poor organ function
  • Participants with baseline SpO2 ≤ 92%.
  • Active brain metastases or leptomeningeal disease.
  • History of allogenic tissue/solid organ transplant
  • Last administration of prior antitumor therapy or any investigational treatment within 28 days or less than 5 times the half-life, whichever is shorter; major surgery or local intervention within 28 days.
  • Has received prior IL-2-based anticancer treatment.
  • Comorbidity requiring corticosteroid therapy
  • Antibiotic use (excluding topical antibiotics) ≤14 days prior to first dose of IMP
  • Severe or unstable cardiac condition within 6 months prior to starting study treatment
  • Active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 years
  • Known second malignancy either progressing or requiring active treatment within the last 3 years
  • Cohorts A1, A2, and C1: Prior treatment with an agent (approved or investigational) that blocks the PD1/PD-L1 pathway (participants who joined a study with an anti-PD1/PD-L1 but have written confirmation they were on control arm are allowed).
  • Receipt of a live-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Sites / Locations

  • Hematology Oncology Clinic-Site Number:8400010
  • Mount Sinai Medical Center-Site Number:8400006
  • Cleveland Clinic Foundation-Site Number:8400004
  • Thomas Jefferson University Hospital-Site Number:8400009
  • Thomas Jefferson University - North East-Site Number:8401009
  • The Sarah Cannon Research Institute-Site Number:8400003
  • Investigational Site Number :0320002
  • Investigational Site Number :0320001
  • Investigational Site Number :0360001
  • Investigational Site Number :0360002
  • Investigational Site Number :1520005
  • Investigational Site Number :1520004
  • Investigational Site Number :1520002
  • Investigational Site Number :1520001
  • Investigational Site Number :1520003
  • Investigational Site Number :2500006
  • Investigational Site Number :2500001
  • Investigational Site Number :2500005
  • Investigational Site Number :2500003
  • Investigational Site Number :3800005
  • Investigational Site Number :3800003
  • Investigational Site Number :3800001
  • Investigational Site Number :3800002
  • Investigational Site Number :3800006
  • Investigational Site Number :3800004
  • Investigational Site Number :3800008
  • Investigational Site Number :3920005
  • Investigational Site Number :3920004
  • Investigational Site Number :3920001
  • Investigational Site Number :3920002
  • Investigational Site Number :4100002
  • Investigational Site Number :4100003
  • Investigational Site Number :4100001
  • Investigational Site Number :6160001
  • Investigational Site Number :6160002
  • Oncology Health Group-Site Number:8400001
  • Investigational Site Number :7240006
  • Investigational Site Number :7240005
  • Investigational Site Number :7240003
  • Investigational Site Number :7240001
  • Investigational Site Number :7240004
  • Investigational Site Number :7240002
  • Investigational Site Number :1580003
  • Investigational Site Number :1580002
  • Investigational Site Number :1580005

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort A1: Non-small cell lung cancer 1rst line therapy with Tumor proportion score > 50%

Cohort A2: Non-small cell lung cancer 1rst line therapy with Tumor proportion score 1-49%

Cohort B1: Non-small cell lung cancer 2/3rd line therapy

Cohort C1: :Mesotheloma 2/3rd line therapy

Arm Description

SAR444245 + pembrolizumab, on day 1 of a 21-day treatment cycle (up 35 cycles).

SAR444245 + pembrolizumab, on day 1 of a 21-day treatment cycle (up 35 cycles).

SAR444245 + pembrolizumab, on day 1 of a 21-day treatment cycle (up 35 cycles).

SAR444245 + pembrolizumab, on day 1 of a 21-day treatment cycle (up 35 cycles).

Outcomes

Primary Outcome Measures

Objective response rate (ORR)
Objective response rate (ORR), defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR), derived based on Investigator's assessment per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for Cohort A1, Cohort A2, and Cohort B1; per modified RECIST (mRECIST) for Cohort C1.

Secondary Outcome Measures

To confirm the dose
Incidence of Dose-limiting toxicities (DLTs) during DLT observation period
Assessment of SAR444245 safety profile when combined with other anticancer therapies-Treatment Emergent Adverse Events
Incidence of Treatment Emergent Adverse Events (TEAEs) and laboratory abnormalities according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus gradings
Assessment of SAR444245 safety profile when combined with other anticancer therapies-Serious Adverse Events
Incidence of Serious Adverse Events (SAEs) and laboratory abnormalities according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus gradings
Time to response
Time to response (TTR) defined as the time from the first administration of investigational medicinal product (IMP) to the first tumor assessment at which the overall response was recorded as PR or CR that is subsequently confirmed and determined by investigator per RECIST 1.1 (for NSCLC) or mRECIST (for mesothelioma)
Duration of response
Duration of response (DoR), defined as the time from first tumor assessment at which the overall response was recorded as PR or CR that is subsequently confirmed until progressive disease (PD) determined by investigator per RECIST 1.1 (for NSCLC) or mRECIST (for mesothelioma) or death from any cause, whichever occurs first.
Clinical benefit rate
Clinical benefit rate (CBR) including CR or PR at any time plus stable disease (SD) of at least 6 months (per RECIST 1.1 [for NSCLC] or mRECIST [for mesothelioma]).
Progression free survival (PFS)
Progression free survival (PFS), defined as the time from the date of first IMP administration to the date of the first documented disease progression as per RECIST 1.1 for NSCLC) or mRECIST (for mesothelioma) or death due to any cause, whichever occurs first
To assess the plasma concentrations of SAR444245
To assess the incidence of anti-drug antibodies (ADAs) against SAR444245.

Full Information

First Posted
May 28, 2021
Last Updated
August 7, 2023
Sponsor
Sanofi
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04914897
Brief Title
A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Lung Cancer or Mesothelioma (Pegathor Lung 202)
Official Title
A Phase 2 Non-randomized, Open-label, Multi-cohort, Multi-center Study Assessing the Clinical Benefit of SAR444245 (THOR-707) Combined With Other Anticancer Therapies for the Treatment of Participants With Lung Cancer or Pleural Mesothelioma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 23, 2021 (Actual)
Primary Completion Date
July 18, 2023 (Actual)
Study Completion Date
February 9, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary Objective: -To determine the antitumor activity of SAR444245 in combination with other anticancer therapies. Secondary Objectives: To confirm the dose and to assess the safety profile of SAR444245 when combined with other anticancer therapies. To assess other indicators of antitumor activity. To assess the pharmacokinetic (PK) profile of SAR444245 when given in combination with pembrolizumab. To assess the immunogenicity of SAR444245.
Detailed Description
The duration of the study for an individual patient will start from the signature of the main informed consent and include a screening period of up to 28 days, a treatment period [max 35 cycles {cohorts A1, A2, and B1} = 735 days or until PD {cohort C1}], an end-of-treatment visit at least 30 days following the last administration of study drug (or until the patient receives another anticancer therapy, whichever is earlier), and a follow-up visit 3 months after treatment discontinuation and every 3 months following, until disease progression, or initiation of another antitumor treatment, or death, whichever is earlier

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Mesothelioma, Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A1: Non-small cell lung cancer 1rst line therapy with Tumor proportion score > 50%
Arm Type
Experimental
Arm Description
SAR444245 + pembrolizumab, on day 1 of a 21-day treatment cycle (up 35 cycles).
Arm Title
Cohort A2: Non-small cell lung cancer 1rst line therapy with Tumor proportion score 1-49%
Arm Type
Experimental
Arm Description
SAR444245 + pembrolizumab, on day 1 of a 21-day treatment cycle (up 35 cycles).
Arm Title
Cohort B1: Non-small cell lung cancer 2/3rd line therapy
Arm Type
Experimental
Arm Description
SAR444245 + pembrolizumab, on day 1 of a 21-day treatment cycle (up 35 cycles).
Arm Title
Cohort C1: :Mesotheloma 2/3rd line therapy
Arm Type
Experimental
Arm Description
SAR444245 + pembrolizumab, on day 1 of a 21-day treatment cycle (up 35 cycles).
Intervention Type
Drug
Intervention Name(s)
THOR-707
Intervention Description
Intravenous infusion: solution for infusion
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda® or generic
Intervention Description
Intravenous infusion: solution for infusion
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Objective response rate (ORR), defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR), derived based on Investigator's assessment per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for Cohort A1, Cohort A2, and Cohort B1; per modified RECIST (mRECIST) for Cohort C1.
Time Frame
Baseline to the date of first documented progression or initiation of subsequent anticancer therapy or approximatively 9 months after the last participant receive first dose
Secondary Outcome Measure Information:
Title
To confirm the dose
Description
Incidence of Dose-limiting toxicities (DLTs) during DLT observation period
Time Frame
Observation period is 1 cycle (21 days)
Title
Assessment of SAR444245 safety profile when combined with other anticancer therapies-Treatment Emergent Adverse Events
Description
Incidence of Treatment Emergent Adverse Events (TEAEs) and laboratory abnormalities according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus gradings
Time Frame
From 1st IMP dose up to 30 days after the last dose of IMP
Title
Assessment of SAR444245 safety profile when combined with other anticancer therapies-Serious Adverse Events
Description
Incidence of Serious Adverse Events (SAEs) and laboratory abnormalities according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus gradings
Time Frame
From 1st IMP dose up to 90 days after the last dose of IMP
Title
Time to response
Description
Time to response (TTR) defined as the time from the first administration of investigational medicinal product (IMP) to the first tumor assessment at which the overall response was recorded as PR or CR that is subsequently confirmed and determined by investigator per RECIST 1.1 (for NSCLC) or mRECIST (for mesothelioma)
Time Frame
From the date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Title
Duration of response
Description
Duration of response (DoR), defined as the time from first tumor assessment at which the overall response was recorded as PR or CR that is subsequently confirmed until progressive disease (PD) determined by investigator per RECIST 1.1 (for NSCLC) or mRECIST (for mesothelioma) or death from any cause, whichever occurs first.
Time Frame
From the date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Title
Clinical benefit rate
Description
Clinical benefit rate (CBR) including CR or PR at any time plus stable disease (SD) of at least 6 months (per RECIST 1.1 [for NSCLC] or mRECIST [for mesothelioma]).
Time Frame
From the date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Title
Progression free survival (PFS)
Description
Progression free survival (PFS), defined as the time from the date of first IMP administration to the date of the first documented disease progression as per RECIST 1.1 for NSCLC) or mRECIST (for mesothelioma) or death due to any cause, whichever occurs first
Time Frame
From the date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Title
To assess the plasma concentrations of SAR444245
Time Frame
Day 1, Day 2, and Day 3 of Cycle1, at Day 1 of Cycle 2-4-7-10 + every 5th cycle (each cycle is 21 days), maximum is up to approximately 24 months
Title
To assess the incidence of anti-drug antibodies (ADAs) against SAR444245.
Time Frame
Day 1 and Day 8 of Cycle1, Day 1 of Cycle 2-4-7-10 + every 5th cycle (each cycle is 21 days) and 30 days after last IMP administration, maximum is up to approximately 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant must be ≥18 years of age (or country's legal age of majority if >18 years), at the time of signing the informed consent. Histologically or cytologically confirmed diagnosis of Stage IV NSCLC (cohorts A1, A2, and B1), or unresectable malignant pleural mesothelioma (cohort C1). Cohort A1: PD-L1 expression TPS ≥ 50% Cohort A2: PD-L1 expression TPS 1 - 49% Prior anticancer therapy Cohorts A1 and A2: No prior systemic therapy for advanced/metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the development of metastatic disease. Cohort B1: One prior anti-PD1/PD-L1 regimen (may include chemotherapy) plus one additional chemotherapy regimen Cohort C1: One or two prior systemic treatments that include pemetrexed-based regimen in combination with platinum agent. All cohorts must have a measurable disease Mandatory baseline biopsy for the first 20 participants to enroll in cohorts A1, A2 Cohort B1: Based on the Investigator's judgment, either docetaxel or pemetrexed is not the best treatment option for the participant. Females are eligible to participate if they are not pregnant or breastfeeding, not a woman of childbearing potential (WOCBP) or are a WOCBP that agrees: to use approved contraception method and submit to regular pregnancy testing prior to treatment and for 150 days after discontinuing study treatment to refrain from donating or cryopreserving eggs for 150 days after discontinuing study treatment. Males are eligible to participate if they agree to refrain from donating or cryopreserving sperm, and either abstain from heterosexual intercourse OR use approved contraception during study treatment and for at least 210 days after discontinuing study treatment. Capable of giving signed informed consent. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 2. Poor bone marrow reserve Poor organ function Participants with baseline SpO2 ≤ 92%. Active brain metastases or leptomeningeal disease. History of allogenic tissue/solid organ transplant Last administration of prior antitumor therapy or any investigational treatment within 28 days or less than 5 times the half-life, whichever is shorter; major surgery or local intervention within 28 days. Has received prior IL-2-based anticancer treatment. Comorbidity requiring corticosteroid therapy Antibiotic use (excluding topical antibiotics) ≤14 days prior to first dose of IMP Severe or unstable cardiac condition within 6 months prior to starting study treatment Active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 years Known second malignancy either progressing or requiring active treatment within the last 3 years Cohorts A1, A2, and C1: Prior treatment with an agent (approved or investigational) that blocks the PD1/PD-L1 pathway (participants who joined a study with an anti-PD1/PD-L1 but have written confirmation they were on control arm are allowed). Receipt of a live-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted. The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Facility Information:
Facility Name
Hematology Oncology Clinic-Site Number:8400010
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Mount Sinai Medical Center-Site Number:8400006
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Cleveland Clinic Foundation-Site Number:8400004
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Thomas Jefferson University Hospital-Site Number:8400009
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Thomas Jefferson University - North East-Site Number:8401009
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
The Sarah Cannon Research Institute-Site Number:8400003
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Investigational Site Number :0320002
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1430
Country
Argentina
Facility Name
Investigational Site Number :0320001
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1019ABS
Country
Argentina
Facility Name
Investigational Site Number :0360001
City
Macquarie Park
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Investigational Site Number :0360002
City
Richmond
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Facility Name
Investigational Site Number :1520005
City
Santaigo
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
8241470
Country
Chile
Facility Name
Investigational Site Number :1520004
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7500713
Country
Chile
Facility Name
Investigational Site Number :1520002
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Investigational Site Number :1520001
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Investigational Site Number :1520003
City
Temuco
ZIP/Postal Code
4800827
Country
Chile
Facility Name
Investigational Site Number :2500006
City
Bordeaux Cedex
Country
France
Facility Name
Investigational Site Number :2500001
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Investigational Site Number :2500005
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Investigational Site Number :2500003
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Investigational Site Number :3800005
City
Aviano (PN)
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33081
Country
Italy
Facility Name
Investigational Site Number :3800003
City
Roma
State/Province
Lazio
ZIP/Postal Code
00144
Country
Italy
Facility Name
Investigational Site Number :3800001
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Investigational Site Number :3800002
City
Orbassano
State/Province
Torino
ZIP/Postal Code
10043
Country
Italy
Facility Name
Investigational Site Number :3800006
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Investigational Site Number :3800004
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Investigational Site Number :3800008
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Investigational Site Number :3920005
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Investigational Site Number :3920004
City
Matsuyama-shi
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Investigational Site Number :3920001
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Investigational Site Number :3920002
City
Ube-shi
State/Province
Yamaguchi
ZIP/Postal Code
755-0241
Country
Japan
Facility Name
Investigational Site Number :4100002
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Investigational Site Number :4100003
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Investigational Site Number :4100001
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Investigational Site Number :6160001
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Investigational Site Number :6160002
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-693
Country
Poland
Facility Name
Oncology Health Group-Site Number:8400001
City
Hato Rey
ZIP/Postal Code
00917
Country
Puerto Rico
Facility Name
Investigational Site Number :7240006
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08035
Country
Spain
Facility Name
Investigational Site Number :7240005
City
Barcelona / Sabadell
State/Province
Catalunya [Cataluña]
ZIP/Postal Code
08208
Country
Spain
Facility Name
Investigational Site Number :7240003
City
Girona
State/Province
Girona [Gerona]
ZIP/Postal Code
17007
Country
Spain
Facility Name
Investigational Site Number :7240001
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28041
Country
Spain
Facility Name
Investigational Site Number :7240004
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28046
Country
Spain
Facility Name
Investigational Site Number :7240002
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Investigational Site Number :1580003
City
Taichung City
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Investigational Site Number :1580002
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Investigational Site Number :1580005
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Learn more about this trial

A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Lung Cancer or Mesothelioma (Pegathor Lung 202)

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