Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers that Progressed on PD-1/PD-L1 Inhibitors (PRESERVE-003)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505311-20-01

Acronym

PRESERVE-003

Enrollment

100

Registered

2024-10-23

Start date

2025-03-21

Completion date

Unknown

Last updated

2025-11-18

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

Conditions

Metastatic Non-Small Cell Lung Cancer

Brief summary

Overall survival (OS)

Detailed description

Objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1, Progression-free survival (PFS) as assessed by BICR per RECIST 1.1, Incidence of TEAEs, TRAEs, irAEs, and AEs leading to treatment discontinuation.

Interventions

DRUGDOCETAXEL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival (OS)	—

Secondary

Measure	Time frame
Objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1, Progression-free survival (PFS) as assessed by BICR per RECIST 1.1, Incidence of TEAEs, TRAEs, irAEs, and AEs leading to treatment discontinuation.	—

Countries

Belgium, Germany, Italy, Netherlands, Spain

Outcome results

None listed

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