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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Sanofi
Study ID
NCT04914897
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • THOR-707 — DRUG
    Intravenous infusion: solution for infusion
  • Pembrolizumab — DRUG
    Intravenous infusion: solution for infusion

Study Details

The Primary Objective was: -To determine the antitumor activity of SAR444245 in combination with other anticancer therapies. The Secondary Objectives were: * 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.

Key Dates

Start date
Sep 23, 2021
Status verified
Sep 2025
Primary completion
Jul 18, 2023
Completion
Oct 17, 2024

Study Design

Enrollment
106 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A1: NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy
    Participants with previously untreated Stage IV non-small cell lung cancer (NSCLC) and programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) of \>=50% were included in this cohort. Participants received pegenzileukin 24 microgram per kilogram (μg/kg) along with pembrolizumab 200 milligram (mg) via intravenous (IV) infusion over 30 minutes every 3 weeks (q3w) on Day 1 of each cycle (each cycle is 21 days) (as first-line \[1L\] therapy), until disease progression (PD), unacceptable adverse event (AE) or other full permanent discontinuation criteria was met or completion of Cycle 35.
  • Experimental: Cohort A2: NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy
    Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
  • Experimental: Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy
    Participants with NSCLC for whom standard of care (SOC) was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as second-line or third-line \[2/3L\] therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
  • Experimental: Cohort C1: Mesothelioma: Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy
    Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.

Primary Outcome Measure

Cohorts A1 and A2: Objective Response Rate (ORR) [ Time Frame: From first dose of study treatment administration (Day 1) up to approximately 21 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Thomas Jefferson University - North East Site Number : 8401009PhiladelphiaPennsylvania19114-
Thomas Jefferson University Hospital Site Number : 8400009PhiladelphiaPennsylvania19107-

Related coverage on Hipa.ai

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By specialty
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By research site
Thomas Jefferson University - North East· Philadelphia, PAThomas Jefferson University Hospital· Philadelphia, PA

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