Randomized, open-label, Phase 3 study of SAR408701 versus docetaxel in previously treated, metastatic nonsquamous, non-small-cell lung cancer patients with CEACAM5-positive tumors

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515101-26-00

Acronym

EFC15858

Enrollment

Registered

2024-11-05

Start date

2020-08-21

Completion date

2024-11-14

Last updated

2024-11-05

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 metastatic

Brief summary

Progression free survival (PFS), Overall Survival (OS)

Detailed description

Objective response rate (ORR), Health related quality of life (HRQOL) - disease related symptoms, Health related quality of life (HRQOL) - physical function, Health related quality of life (HRQOL) - role function, Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs), Duration of response (DOR)

Interventions

DRUGDOCETAXEL

DRUGTusamitamab ravtansine

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression free survival (PFS), Overall Survival (OS)	—

Secondary

Measure	Time frame
Objective response rate (ORR), Health related quality of life (HRQOL) - disease related symptoms, Health related quality of life (HRQOL) - physical function, Health related quality of life (HRQOL) - role function, Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs), Duration of response (DOR)	—

Countries

France

Outcome results

None listed

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