IFCT-2401 SPORADIC A multicenter randomized open label phase II study evaluating the efficacy and the tolerance of Immunochemotherapy and of Sequential hyPOfractionated RADiotherapy in unfit or elderly patients with unresectable stage III non-small cell lung cancer

Conditions

Unresectable stage III Non-Small Cell Lung Cancer

Brief summary

Progression-free survival (PFS)

Detailed description

Objective response (ORR) and disease control (DCR) rates according to RECIST 1.1 criteria., PFS rate at 12 months, 18 months and 3 years by treatment arm., OS curve and OS rate at 12 months, 18 months and 3 years by treatment arm., Grade 3-4 toxicity rates by treatment arm according to CTCAE v5.0 up to 90 days after the end of immunotherapy, Percentage of discontinuation after two cycles of systemic therapy., Toxic death rate., Variation of respiratory function tests before neoadjuvant therapy and after neoadjuvant therapy (just before radiation) and after, at 3, 6 and 12 months., Global and specific quality of life questionnaire QLQ-C30 QLQ-LC29.

S. Thureau, Judith Raimbourg, N. Pourel, Hubert Curcio, Marie Wislez et al. (14 authors)

Journal of Clinical Oncology2026-05-28

10.1200/jco.2026.44.16_suppl.tps8128

Interventions

DRUGLIBTAYO 350 mg concentrate for solution for infusion.

DRUGCARBOPLATIN

DRUGPACLITAXEL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS)	—

Secondary

Measure	Time frame
Objective response (ORR) and disease control (DCR) rates according to RECIST 1.1 criteria., PFS rate at 12 months, 18 months and 3 years by treatment arm., OS curve and OS rate at 12 months, 18 months and 3 years by treatment arm., Grade 3-4 toxicity rates by treatment arm according to CTCAE v5.0 up to 90 days after the end of immunotherapy, Percentage of discontinuation after two cycles of systemic therapy., Toxic death rate., Variation of respiratory function tests before neoadjuvant therapy and after neoadjuvant therapy (just before radiation) and after, at 3, 6 and 12 months., Global and specific quality of life questionnaire QLQ-C30 QLQ-LC29.	—

Measure

Time frame

Objective response (ORR) and disease control (DCR) rates according to RECIST 1.1 criteria., PFS rate at 12 months, 18 months and 3 years by treatment arm., OS curve and OS rate at 12 months, 18 months and 3 years by treatment arm., Grade 3-4 toxicity rates by treatment arm according to CTCAE v5.0 up to 90 days after the end of immunotherapy, Percentage of discontinuation after two cycles of systemic therapy., Toxic death rate., Variation of respiratory function tests before neoadjuvant therapy and after neoadjuvant therapy (just before radiation) and after, at 3, 6 and 12 months., Global and specific quality of life questionnaire QLQ-C30 QLQ-LC29.

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Countries

France

Outcome results

None listed