Lung Cancer Clinical Trial

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

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.

View Full Description

Full 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

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

160

Study ID:

NCT04914897

Recruitment Status:

Active, not recruiting

Sponsor:

Sanofi

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There are 43 Locations for this study

See Locations Near You

Hematology Oncology Clinic-Site Number:8400010
Baton Rouge Louisiana, 70809, United States
Mount Sinai Medical Center-Site Number:8400006
New York New York, 10021, United States
Cleveland Clinic Foundation-Site Number:8400004
Cleveland Ohio, 44195, United States
Thomas Jefferson University Hospital-Site Number:8400009
Philadelphia Pennsylvania, 19107, United States
Thomas Jefferson University - North East-Site Number:8401009
Philadelphia Pennsylvania, 19114, United States
The Sarah Cannon Research Institute-Site Number:8400003
Nashville Tennessee, 37203, United States
Investigational Site Number :0320002
Caba Buenos Aires, 1430, Argentina
Investigational Site Number :0320001
Caba Buenos Aires, C1019, Argentina
Investigational Site Number :0360001
Macquarie Park New South Wales, 2109, Australia
Investigational Site Number :0360002
Richmond Victoria, 3121, Australia
Investigational Site Number :1520005
Santaigo Reg Metropolitana De Santiago, 82414, Chile
Investigational Site Number :1520004
Santiago Reg Metropolitana De Santiago, 75007, Chile
Investigational Site Number :1520002
Santiago Reg Metropolitana De Santiago, 75009, Chile
Investigational Site Number :1520001
Santiago Reg Metropolitana De Santiago, 84203, Chile
Investigational Site Number :1520003
Temuco , 48008, Chile
Investigational Site Number :2500006
Bordeaux Cedex , , France
Investigational Site Number :2500001
Nantes , 44093, France
Investigational Site Number :2500005
Paris , 75018, France
Investigational Site Number :2500003
Toulouse , 31059, France
Investigational Site Number :3800005
Aviano (PN) Friuli-Venezia Giulia, 33081, Italy
Investigational Site Number :3800003
Roma Lazio, 00144, Italy
Investigational Site Number :3800001
Rozzano Milano, 20089, Italy
Investigational Site Number :3800002
Orbassano Torino, 10043, Italy
Investigational Site Number :3800006
Bologna , 40138, Italy
Investigational Site Number :3800004
Milano , 20133, Italy
Investigational Site Number :3800008
Padova , 35128, Italy
Investigational Site Number :3920005
Nagoya-shi Aichi, 460-0, Japan
Investigational Site Number :3920004
Matsuyama-shi Ehime, 791-0, Japan
Investigational Site Number :3920001
Sapporo-shi Hokkaido, 003-0, Japan
Investigational Site Number :3920002
Ube-shi Yamaguchi, 755-0, Japan
Investigational Site Number :4100002
Seoul Seoul-teukbyeolsi, 03080, Korea, Republic of
Investigational Site Number :4100003
Seoul Seoul-teukbyeolsi, 05505, Korea, Republic of
Investigational Site Number :4100001
Seoul Seoul-teukbyeolsi, 06351, Korea, Republic of
Investigational Site Number :6160001
Warszawa Mazowieckie, 02-78, Poland
Investigational Site Number :6160002
Poznan Wielkopolskie, 60-69, Poland
Oncology Health Group-Site Number:8400001
Hato Rey , 00917, Puerto Rico
Investigational Site Number :7240006
Barcelona Barcelona [Barcelona], 08035, Spain
Investigational Site Number :7240005
Barcelona / Sabadell Catalunya [Cataluña], 08208, Spain
Investigational Site Number :7240003
Girona Girona [Gerona], 17007, Spain
Investigational Site Number :7240001
Madrid Madrid, Comunidad De, 28041, Spain
Investigational Site Number :7240004
Madrid Madrid, Comunidad De, 28046, Spain
Investigational Site Number :7240002
Madrid , 28034, Spain
Investigational Site Number :1580003
Taichung City , 404, Taiwan
Investigational Site Number :1580002
Tainan , 704, Taiwan
Investigational Site Number :1580005
Taipei , , Taiwan

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

160

Study ID:

NCT04914897

Recruitment Status:

Active, not recruiting

Sponsor:


Sanofi

How clear is this clinincal trial information?

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