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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04914897




Registration number
NCT04914897
Ethics application status
Date submitted
28/05/2021
Date registered
7/06/2021

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)
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
Secondary ID [1] 0 0
U1111-1254-0107
Secondary ID [2] 0 0
ACT16849
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pleural Mesothelioma 0 0
Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR)
Timepoint [1] 0 0
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 [1] 0 0
To confirm the dose
Timepoint [1] 0 0
Observation period is 1 cycle (21 days)
Secondary outcome [2] 0 0
Assessment of SAR444245 safety profile when combined with other anticancer therapies-Treatment Emergent Adverse Events
Timepoint [2] 0 0
From 1st IMP dose up to 30 days after the last dose of IMP
Secondary outcome [3] 0 0
Assessment of SAR444245 safety profile when combined with other anticancer therapies-Serious Adverse Events
Timepoint [3] 0 0
From 1st IMP dose up to 90 days after the last dose of IMP
Secondary outcome [4] 0 0
Time to response
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
Duration of response
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
Clinical benefit rate
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
Progression free survival (PFS)
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
To assess the plasma concentrations of SAR444245
Timepoint [8] 0 0
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
Secondary outcome [9] 0 0
To assess the incidence of anti-drug antibodies (ADAs) against SAR444245.
Timepoint [9] 0 0
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

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/10/2024
Sample size
Target
Accrual to date
Final
106
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0360002 - Richmond
Recruitment postcode(s) [1] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Pennsylvania
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Chile
State/province [3] 0 0
Reg Metropolitana De Santiago
Country [4] 0 0
Chile
State/province [4] 0 0
Temuco
Country [5] 0 0
France
State/province [5] 0 0
Bordeaux Cedex
Country [6] 0 0
France
State/province [6] 0 0
Paris
Country [7] 0 0
France
State/province [7] 0 0
Saint Herblain
Country [8] 0 0
France
State/province [8] 0 0
Toulouse
Country [9] 0 0
Italy
State/province [9] 0 0
Friuli-Venezia Giulia
Country [10] 0 0
Italy
State/province [10] 0 0
Milano
Country [11] 0 0
Italy
State/province [11] 0 0
Torino
Country [12] 0 0
Italy
State/province [12] 0 0
Bologna
Country [13] 0 0
Italy
State/province [13] 0 0
Padova
Country [14] 0 0
Japan
State/province [14] 0 0
Hokkaido
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul-teukbyeolsi
Country [16] 0 0
Poland
State/province [16] 0 0
Mazowieckie
Country [17] 0 0
Poland
State/province [17] 0 0
Pomorskie
Country [18] 0 0
Poland
State/province [18] 0 0
Warminsko-mazurskie
Country [19] 0 0
Poland
State/province [19] 0 0
Wielkopolskie
Country [20] 0 0
Spain
State/province [20] 0 0
Barcelona [Barcelona]
Country [21] 0 0
Spain
State/province [21] 0 0
Girona [Gerona]
Country [22] 0 0
Spain
State/province [22] 0 0
Madrid, Comunidad De
Country [23] 0 0
Spain
State/province [23] 0 0
Madrid
Country [24] 0 0
Taiwan
State/province [24] 0 0
Taichung City
Country [25] 0 0
Taiwan
State/province [25] 0 0
Tainan
Country [26] 0 0
Taiwan
State/province [26] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04914897