Skip to content

A randomized, double-blind, placebo-controlled, Phase 2 study evaluating efficacy and safety of inupadenant in combination with carboplatin and pemetrexed in adults with nonsquamous non-small cell lung cancer who have progressed on immunotherapy

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515393-27-00
Acronym
A2A-005
Enrollment
131
Registered
2024-09-17
Start date
Unknown
Completion date
2025-10-24
Last updated
2025-06-10

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

Conditions

Nonsquamous non-small cell lung cancer

Brief summary

Part 1 (Dose-Finding): Incidence of adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), AEs leading to dose-modifications or discontinuation, deaths, and clinically significant laboratory abnormalities., Part 2 (Randomized): Progression-free survival (PFS), defined as time from randomization to the date of first documented radiological progression using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria or death due to any cause

Detailed description

Part 1: ORR; DoR; percent CTS from baseline; DCR, PFS, OS., Part 2: Incidence and frequency of AEs, SAEs, and AEs leading to dose modifications or discontinuation, deaths, and clinically significant laboratory abnormalities., Part 2: ORR; DoR; percent CTS from baseline; DCR; OS., Part 2: Time to definitive deterioration in global health status/quality of life (QoL), shortness of breath and pain per EORTC QLQ-C30 questionnaire. Please refer to Protocol for other secondary endpoints.

Interventions

DRUGPlacebo to Inupadenant

Sponsors

iTeos Belgium
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Part 1 (Dose-Finding): Incidence of adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), AEs leading to dose-modifications or discontinuation, deaths, and clinically significant laboratory abnormalities., Part 2 (Randomized): Progression-free survival (PFS), defined as time from randomization to the date of first documented radiological progression using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria or death due to any cause

Secondary

MeasureTime frame
Part 1: ORR; DoR; percent CTS from baseline; DCR, PFS, OS., Part 2: Incidence and frequency of AEs, SAEs, and AEs leading to dose modifications or discontinuation, deaths, and clinically significant laboratory abnormalities., Part 2: ORR; DoR; percent CTS from baseline; DCR; OS., Part 2: Time to definitive deterioration in global health status/quality of life (QoL), shortness of breath and pain per EORTC QLQ-C30 questionnaire. Please refer to Protocol for other secondary endpoints.

Countries

Belgium, Czechia, France, Germany, Italy, Spain

Outcome results

None listed

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