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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04914897
Registration number
NCT04914897
Ethics application status
Date submitted
28/05/2021
Date registered
7/06/2021
Date last updated
28/03/2024
Titles & IDs
Public title
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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Scientific 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
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Secondary ID [1]
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U1111-1254-0107
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Secondary ID [2]
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ACT16849
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pleural Mesothelioma
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Non-small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - THOR-707
Treatment: Drugs - Pembrolizumab
Experimental: Cohort A1: Non-small cell lung cancer 1rst line therapy with Tumor proportion score > 50% - SAR444245 + pembrolizumab, on day 1 of a 21-day treatment cycle (up 35 cycles).
Experimental: Cohort A2: Non-small cell lung cancer 1rst line therapy with Tumor proportion score 1-49% - SAR444245 + pembrolizumab, on day 1 of a 21-day treatment cycle (up 35 cycles).
Experimental: Cohort B1: Non-small cell lung cancer 2/3rd line therapy - SAR444245 + pembrolizumab, on day 1 of a 21-day treatment cycle (up 35 cycles).
Experimental: Cohort C1: :Mesotheloma 2/3rd line therapy - SAR444245 + pembrolizumab, on day 1 of a 21-day treatment cycle (up 35 cycles).
Treatment: Drugs: THOR-707
Intravenous infusion: solution for infusion
Treatment: Drugs: Pembrolizumab
Intravenous infusion: solution for infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective response rate (ORR)
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Assessment method [1]
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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.
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Timepoint [1]
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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
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Secondary outcome [1]
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To confirm the dose
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Assessment method [1]
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Incidence of Dose-limiting toxicities (DLTs) during DLT observation period
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Timepoint [1]
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Observation period is 1 cycle (21 days)
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Secondary outcome [2]
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Assessment of SAR444245 safety profile when combined with other anticancer therapies-Treatment Emergent Adverse Events
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Assessment method [2]
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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
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Timepoint [2]
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From 1st IMP dose up to 30 days after the last dose of IMP
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Secondary outcome [3]
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Assessment of SAR444245 safety profile when combined with other anticancer therapies-Serious Adverse Events
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Assessment method [3]
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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
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Timepoint [3]
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From 1st IMP dose up to 90 days after the last dose of IMP
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Secondary outcome [4]
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Time to response
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Assessment method [4]
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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)
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Timepoint [4]
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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
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Secondary outcome [5]
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Duration of response
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Assessment method [5]
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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.
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Timepoint [5]
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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
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Secondary outcome [6]
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Clinical benefit rate
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Assessment method [6]
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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]).
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Timepoint [6]
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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
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Secondary outcome [7]
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Progression free survival (PFS)
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Assessment method [7]
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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
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Timepoint [7]
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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
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Secondary outcome [8]
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To assess the plasma concentrations of SAR444245
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Assessment method [8]
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Timepoint [8]
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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
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Secondary outcome [9]
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To assess the incidence of anti-drug antibodies (ADAs) against SAR444245.
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Assessment method [9]
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Timepoint [9]
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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
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/09/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
22/01/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
106
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Investigational Site Number : 0360002 - Richmond
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Recruitment postcode(s) [1]
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3121 - Richmond
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Pennsylvania
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Argentina
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State/province [2]
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Buenos Aires
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Chile
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State/province [3]
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Reg Metropolitana De Santiago
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Chile
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Temuco
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France
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Bordeaux Cedex
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Country [6]
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France
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Paris
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Country [7]
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France
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State/province [7]
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Saint Herblain
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France
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State/province [8]
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Toulouse
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Italy
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Friuli-Venezia Giulia
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Italy
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Milano
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Italy
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Torino
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Italy
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Bologna
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Italy
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Padova
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Japan
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Hokkaido
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Korea, Republic of
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Seoul-teukbyeolsi
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Poland
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Mazowieckie
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Pomorskie
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Poland
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Warminsko-mazurskie
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Poland
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Wielkopolskie
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Spain
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Barcelona [Barcelona]
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Spain
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Girona [Gerona]
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Spain
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Madrid, Comunidad De
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Spain
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Madrid
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Taiwan
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Taichung City
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Taiwan
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Tainan
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Taiwan
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State/province [26]
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Merck Sharp & Dohme LLC
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Address [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04914897
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04914897
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