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

Investigating the Effects of an Investigational Medication in Combination with Cancer Treatments

Enrolling By Invitation
18 years or above
All
Phase 1/2
107 participants needed
1 Location

Study Overview

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.

Study Details

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

Eligibility Criteria

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

  • Conditions: Pleural Mesothelioma, Non-small Cell Lung Cancer
  • Age: 18 years or above
  • Gender: All

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.

Updated on 06 Feb 2025. Study ID: NCT04914897

This study investigates the effects of an investigational medication combined with other anticancer therapies for patients with advanced cancer. The main goal is to see how well this combination works against tumors. The study also looks at the safety of using this investigational medication with other treatments and how the body processes it, especially when used with a specific type of cancer treatment called pembrolizumab. Additionally, the study examines how the immune system responds to the investigational medication.

Participants will undergo different procedures as part of the study. They will receive the investigational medication along with other anticancer therapies over several cycles. The study involves regular monitoring of the participants' health through blood tests, imaging scans, and other assessments to track the medication's effects and any side effects. Participants will also have regular check-ups to ensure their safety throughout the study.

  • Who can participate: Adults aged 18 or older with Stage IV non-small cell lung cancer or unresectable malignant pleural mesothelioma may participate. Key eligibility factors include having a measurable disease and prior therapy without active brain metastases or certain other health conditions.
  • Study details: Participants will receive an investigational medication combined with other treatments. They will be monitored for their body's reaction to the treatment and any side effects. A placebo may be used in some parts of the study.
  • Study timelines: The study will last 735 days or until disease progression.
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