IFCT-2203 TAXIO A phase II study assessing the efficacy of etoposide free chemotherapy plus durvalumab (MEDI4736) in first line extensive disease Small Cell Lung Cancer (SCLC)

Conditions

Extensive disease Small Cell Lung Cancer

Brief summary

Overall Survival (OS) rate at 12 months

Detailed description

Best response rate (RECIST 1.1) which is defined as the percentage of subjects with a complete response (CR) or partial response (PR) determined by Investigator review and by independent reviewer as per RECIST v1.1 criteria, Overall Survival (OS) defined as the time from the date of first dose of study drug to the date of death due to any cause, Overall Survival (OS) at 24 months and at 36 months, Progression free survival (PFS) defined as the time from the date of first dose of study drug to the earliest date of disease progression, as determined by Investigator review and by independent reviewer of radiographic disease assessments per RECIST v1.1, or death due to any cause, Duration of response (DOR) defined as the time from the date of the best documented response (CR or PR) to the earliest date of disease progression, as determined by Investigator review and by independent reviewer of radiographic disease assessments per RECIST v1.1, or death due to any cause, Incidence, nature, and severity of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), Change from baseline of Quality of life assessment using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30 LC13)at all scheduled time points.

Denis Lucien MORO SIBILOT, A. Baranzelli, Etienne Giroux‐Leprieur, Karim Amrane, O. Leleu et al. (13 authors)

Journal of Clinical Oncology2026-05-28

10.1200/jco.2026.44.16_suppl.8091

Study design and rationale for IFCT- 2203 TAXIO: A study that aims to evaluate the effectiveness of a first-line chemotherapy regimen without etoposide, combined with durvalumab, for patients with extensive disease small cell lung cancer

Denis Moro‐Sibilot, L. Falchero, Camille Ardin, Ayoube Zouak, Olivier Molinier et al. (12 authors)

Respiratory Medicine and Research2024-04-30

10.1016/j.resmer.2024.101113

Interventions

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

DRUGCARBOPLATIN

DRUGPACLITAXEL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS) rate at 12 months	—

Secondary

Measure	Time frame
Best response rate (RECIST 1.1) which is defined as the percentage of subjects with a complete response (CR) or partial response (PR) determined by Investigator review and by independent reviewer as per RECIST v1.1 criteria, Overall Survival (OS) defined as the time from the date of first dose of study drug to the date of death due to any cause, Overall Survival (OS) at 24 months and at 36 months, Progression free survival (PFS) defined as the time from the date of first dose of study drug to the earliest date of disease progression, as determined by Investigator review and by independent reviewer of radiographic disease assessments per RECIST v1.1, or death due to any cause, Duration of response (DOR) defined as the time from the date of the best documented response (CR or PR) to the earliest date of disease progression, as determined by Investigator review and by independent reviewer of radiographic disease assessments per RECIST v1.1, or death due to any cause, Incidence, nature, an	—

Measure

Time frame

Best response rate (RECIST 1.1) which is defined as the percentage of subjects with a complete response (CR) or partial response (PR) determined by Investigator review and by independent reviewer as per RECIST v1.1 criteria, Overall Survival (OS) defined as the time from the date of first dose of study drug to the date of death due to any cause, Overall Survival (OS) at 24 months and at 36 months, Progression free survival (PFS) defined as the time from the date of first dose of study drug to the earliest date of disease progression, as determined by Investigator review and by independent reviewer of radiographic disease assessments per RECIST v1.1, or death due to any cause, Duration of response (DOR) defined as the time from the date of the best documented response (CR or PR) to the earliest date of disease progression, as determined by Investigator review and by independent reviewer of radiographic disease assessments per RECIST v1.1, or death due to any cause, Incidence, nature, an

—

Countries

France, Luxembourg

Outcome results

None listed