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A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 193 in Subjects with Methylthioadenosine Phosphorylase (MTAP)-deleted Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514459-14-00
Acronym
20230153
Enrollment
107
Registered
2025-03-04
Start date
2025-04-22
Completion date
Unknown
Last updated
2025-11-06

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

Brief summary

Objective response (OR) (complete response [CR] and partial response [PR]) measured by computed tomography (CT) or Magnetic resonance imaging (MRI) and assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), Incidence of treatment-emergent adverse events (TEAEs), grade ≥ 3 TEAEs, Serious Adverse Events (SAEs), and Events of Interest (EOIs), Pharmacokinetic (PK) parameters of AMG 193 including, but not limited to, maximum concentration (Cmax), time to maximum concentration (Tmax), and area under the concentration-time curve (AUC), OR (CR and PR) per RECIST 1.1

Detailed description

Disease control (DC), Duration of response (DOR), Time to response (TTR), Progression free survival (PFS), OR (CR and PR), DC, DOR, TTR, PFS, Overall survival (OS), Incidence and severity of TEAEs, grade ≥ 3 TEAEs, SAEs, and EOIs, PK parameters of AMG 193 including, but not limited to Cmax, Tmax, and AUC, Changes in cancer-specific symptoms, treatment-related symptom and overall health status using subject-reported outcome instruments: o EORTC QLQ-C30 o QLQ LC13 o EQ-5D-5L o PRO-CTCAE o GP5 of FACT-G

Interventions

Sponsors

Amgen Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Objective response (OR) (complete response [CR] and partial response [PR]) measured by computed tomography (CT) or Magnetic resonance imaging (MRI) and assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), Incidence of treatment-emergent adverse events (TEAEs), grade ≥ 3 TEAEs, Serious Adverse Events (SAEs), and Events of Interest (EOIs), Pharmacokinetic (PK) parameters of AMG 193 including, but not limited to, maximum concentration (Cmax), time to maximum concentration (Tmax), and area under the concentration-time curve (AUC), OR (CR and PR) per RECIST 1.1

Secondary

MeasureTime frame
Disease control (DC), Duration of response (DOR), Time to response (TTR), Progression free survival (PFS), OR (CR and PR), DC, DOR, TTR, PFS, Overall survival (OS), Incidence and severity of TEAEs, grade ≥ 3 TEAEs, SAEs, and EOIs, PK parameters of AMG 193 including, but not limited to Cmax, Tmax, and AUC, Changes in cancer-specific symptoms, treatment-related symptom and overall health status using subject-reported outcome instruments: o EORTC QLQ-C30 o QLQ LC13 o EQ-5D-5L o PRO-CTCAE o GP5 of FACT-G

Countries

Belgium, Czechia, France, Germany, Greece, Hungary, Italy, Latvia, Netherlands, Poland, Portugal, Spain

Outcome results

None listed

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