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A Phase 1b/2, multicenter, open-label platform study of select immunotherapy combinations in adult participants with previously untreated advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508730-34-00
Acronym
SPLFIO-174
Enrollment
93
Registered
2024-06-17
Start date
2024-07-10
Completion date
Unknown
Last updated
2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer (NSCLC): - Locally advanced NSCLC where participants are not candidates for surgical resection and/or definitive chemoradiation, or - Metastatic NSCLC

Brief summary

Part A (combination therapy safety lead-in): Incidence and severity of dose-limiting toxicities (DLTs) during the first 2 cycles of combination treatment, Part A (combination therapy safety lead-in): Incidence and severity of adverse events (AEs), serious adverse events (SAEs), changes from baseline in laboratory values/laboratory abnormalities, electrocardiograms (ECGs) and vital signs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0), Part A (combination therapy safety lead-in): AEs leading to dose interruption, modification, delays, and permanent treatment discontinuation, Part B (Randomized dose expansion): Objective Response (OR) per investigator assessment using RECIST v1.1

Detailed description

Part A (combination therapy safety lead-in): Objective response (OR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune Response Evaluation Criteria in Solid Tumors (iRECIST) as assessed by the investigator, Part B (Randomized dose expansion): Objective response (OR) according to immune Response Evaluation Criteria in Solid Tumors (iRECIST) as assessed by the investigator, Part A (combination therapy safety lead-in) and Part B (Randomized dose expansion): best overall response (BOR), duration of response (DoR), disease control (DC), 6-month durable response (6-month DR) and Progression-Free Survival (PFS), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune RECIST (iRECIST) as assessed by the investigator, Part A (combination therapy safety lead-in) and Part B (Randomized dose expansion): Overall survival (OS), Part A (combination therapy safety lead-in) and Part B (Randomized dose expansion): Plasma or serum concentrations of S095018, S095024 or S095029, Part A (combination therapy safety lead-in) and Part B (Randomized dose expansion): Incidence and titer of anti-drug antiodies (ADA) directed against S095018, S095024 or S095029, Part B (Randomized dose expansion): Incidence and severity of adverse events (AEs), serious adverse events (SAEs), changes in laboratory values/laboratory abnormalities, ECGs and vital signs according to NCI-CTCAE v5.0, Part B (Randomized dose expansion): AEs leading to dose interruption, modification, delays, and permanent treatment discontinuation

Interventions

DRUGLIBTAYO 350 mg concentrate for solution for infusion.
DRUGS095018/Sym023
DRUGS095024/Sym024

Sponsors

Institut De Recherches Internationales Servier IRIS
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Part A (combination therapy safety lead-in): Incidence and severity of dose-limiting toxicities (DLTs) during the first 2 cycles of combination treatment, Part A (combination therapy safety lead-in): Incidence and severity of adverse events (AEs), serious adverse events (SAEs), changes from baseline in laboratory values/laboratory abnormalities, electrocardiograms (ECGs) and vital signs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0), Part A (combination therapy safety lead-in): AEs leading to dose interruption, modification, delays, and permanent treatment discontinuation, Part B (Randomized dose expansion): Objective Response (OR) per investigator assessment using RECIST v1.1

Secondary

MeasureTime frame
Part A (combination therapy safety lead-in): Objective response (OR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune Response Evaluation Criteria in Solid Tumors (iRECIST) as assessed by the investigator, Part B (Randomized dose expansion): Objective response (OR) according to immune Response Evaluation Criteria in Solid Tumors (iRECIST) as assessed by the investigator, Part A (combination therapy safety lead-in) and Part B (Randomized dose expansion): best overall response (BOR), duration of response (DoR), disease control (DC), 6-month durable response (6-month DR) and Progression-Free Survival (PFS), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune RECIST (iRECIST) as assessed by the investigator, Part A (combination therapy safety lead-in) and Part B (Randomized dose expansion): Overall survival (OS), Part A (combination therapy safety lead-in) and Part B (Randomized dose expansion): Plasma or serum concentration

Countries

Austria, Belgium, France, Hungary, Italy, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026