NCT04914897

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

A Phase 2 Non-randomized, Open-label, Multi-cohort, Multi-center Study Assessing the Clinical Benefit of SAR444245 (THOR-707) Combined With Other Anticancer Therapies for the Treatment of Participants With Lung Cancer or Pleural Mesothelioma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	THOR-707	Intravenous infusion: solution for infusion
DRUG	Pembrolizumab	Intravenous infusion: solution for infusion

Timeline

• Start date: 2021-09-23
• Primary completion: 2023-07-18
• Completion: 2024-10-17
• First posted: 2021-06-07
• Last updated: 2025-10-02
• Results posted: 2025-10-02

Locations

35 sites across 11 countries: United States, Argentina, Australia, Chile, France, Italy, Japan, Poland, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study