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

Brief description of study

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.

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 {cohort A1, A2, B1, B2 and C1} or until PD {cohort A3}], an end-of-treatment visit approximately 30 days following the last administration of study drug (or until the patient receives another anticancer therapy, whichever is earlier), and follow-up visits 3 months after treatment discontinuation and every 3 months thereafter, until disease progression, or initiation of another antitumor treatment, or death, whichever is earlier.

Clinical Study Identifier: NCT04914897

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pleural Mesothelioma, Non-small Cell Lung Cancer
  • Age: 18 Years
  • Gender: Male or Female

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, B1, B2), Stage IV non-squamous NSCLC (cohort A3), 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, A2, A3: 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
  • Cohorts B1, B2: One prior anti-PD1/PD-L1 regimen (given concurrently or sequentially with Platinum based 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 Cohorts B1 and B2: 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 at least 420 days (Cohort A3) or 150 days (Cohorts A1, A2, B1, B2, C1)
        after discontinuing study treatment
        to refrain from donating or cryopreserving eggs for 150 days after discontinuing study
          -  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 330 days (Cohort A3) or 210 days
             (Cohorts A1, A2, B1, B2, C1) and after discontinuing study treatment
          -  Capable of giving signed informed consent
        Exclusion Criteria:
          -  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
          -  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, A3, 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 or live-attenuated 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 a patient's
        potential participation in a clinical trial.

Last updated on 22 Jun 2022

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