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

NCT ID: NCT04914897

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-23
• Study Completion Date: 2024-10-17

Brief Summary

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.

Detailed Description

The duration of the study for an individual participant started from the signature of the main informed consent and included 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 participant 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

Conditions

Pleural Mesothelioma; Non-small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

THOR-707

Intervention Type: DRUG

Intravenous infusion: solution for infusion

Pembrolizumab

Intervention Type: DRUG

Intravenous infusion: solution for infusion

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.

Group Type: EXPERIMENTAL

THOR-707

Intervention Type: DRUG

Intravenous infusion: solution for infusion

Pembrolizumab

Intervention Type: DRUG

Intravenous infusion: solution for infusion

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.

Group Type: EXPERIMENTAL

THOR-707

Intervention Type: DRUG

Intravenous infusion: solution for infusion

Pembrolizumab

Intervention Type: DRUG

Intravenous infusion: solution for infusion

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.

Group Type: EXPERIMENTAL

THOR-707

Intervention Type: DRUG

Intravenous infusion: solution for infusion

Pembrolizumab

Intervention Type: DRUG

Intravenous infusion: solution for infusion

Interventions

THOR-707

Intravenous infusion: solution for infusion

Intervention Type: DRUG

Pembrolizumab

Intravenous infusion: solution for infusion

Intervention Type: DRUG

Other Intervention Names

Pegenzileukin; KEYTRUDA® or generic

Eligibility Criteria

Inclusion Criteria

• Participant must have been ≥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 had 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 were eligible to participate if they were 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 were 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 were excluded from the study if any of the following criteria applied:

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Thomas Jefferson University Hospital Site Number : 8400009

Philadelphia, Pennsylvania, United States

Thomas Jefferson University - North East Site Number : 8401009

Philadelphia, Pennsylvania, United States

Investigational Site Number : 0320002

CABA, Buenos Aires, Argentina

Investigational Site Number : 0360002

Richmond, Victoria, Australia

Investigational Site Number : 1520005

Santaigo, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520004

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520003

Temuco, , Chile

Investigational Site Number : 2500006

Bordeaux, , France

Investigational Site Number : 2500005

Paris, , France

Investigational Site Number : 2500001

Saint-Herblain, , France

Investigational Site Number : 2500003

Toulouse, , France

Investigational Site Number : 3800005

Aviano (PN), Friuli Venezia Giulia, Italy

Investigational Site Number : 3800001

Rozzano, Milano, Italy

Investigational Site Number : 3800002

Orbassano, Torino, Italy

Investigational Site Number : 3800006

Bologna, , Italy

Investigational Site Number : 3800004

Milan, , Italy

Investigational Site Number : 3800008

Padua, , Italy

Investigational Site Number : 3920001

Sapporo, Hokkaido, Japan

Investigational Site Number : 6160002

Poznan, Greater Poland Voivodeship, Poland

Investigational Site Number : 6160001

Warsaw, Masovian Voivodeship, Poland

Investigational Site Number : 6160003

Gdansk, Pomeranian Voivodeship, Poland

Investigational Site Number : 6160004

Olsztyn, Warmian-Masurian Voivodeship, Poland

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 4100003

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 7240006

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240003

Girona, Girona [Gerona], Spain

Investigational Site Number : 7240004

Madrid, Madrid, Comunidad de, Spain

Investigational Site Number : 7240002

Madrid, , Spain

Investigational Site Number : 7240001

Madrid, , Spain

Investigational Site Number : 1580003

Taichung, , Taiwan

Investigational Site Number : 1580002

Tainan City, , Taiwan

Investigational Site Number : 1580005

Taipei, , Taiwan

Countries

United States; Argentina; Australia; Chile; France; Italy; Japan; Poland; South Korea; Spain; Taiwan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://sanofi.trialsummaries.com/Study/StudyDetails?id=25200&tenant=MT_SNY_9011

ACT16849 Plain Language Results Summary

Other Identifiers

U1111-1254-0107

Identifier Type: REGISTRY

Identifier Source: secondary_id

MK-3475-B71

Identifier Type: OTHER

Identifier Source: secondary_id

KEYNOTE-B71

Identifier Type: OTHER

Identifier Source: secondary_id

2020-005331-78

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ACT16849

Identifier Type: -

Identifier Source: org_study_id