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

  • STATUS
    Recruiting
  • End date
    Feb 9, 2024
  • participants needed
    160
  • sponsor
    Sanofi
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Updated on 15 October 2022
See if I qualify
paclitaxel
systemic therapy
measurable disease
pemetrexed
carboplatin
pembrolizumab
docetaxel
cancer chemotherapy
lung carcinoma

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.

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

Details
Condition Pleural Mesothelioma, Non-small Cell Lung Cancer
Treatment cisplatin, carboplatin, Pembrolizumab, Pemetrexed, Nab-paclitaxel, THOR-707, SAR444245
Clinical Study IdentifierNCT04914897
SponsorSanofi
Last Modified on15 October 2022

Eligibility

 Yes No Not Sure

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
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
Males are eligible to participate if they agree to refrain from donating or
Capable of giving signed informed consent

Exclusion Criteria

Participants are excluded from the study if any of the following criteria
Poor bone marrow reserve
apply
Poor organ function
Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 2
Participants with baseline SpO2 ≤ 92%
Has received prior IL-2-based anticancer treatment
Active brain metastases or leptomeningeal disease
Comorbidity requiring corticosteroid therapy
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
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
Antibiotic use (excluding topical antibiotics) ≤14 days prior to first dose of IMP
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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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