Open-label, Phase 2 study of tusamitamab ravtansine (SAR408701) combined with pembrolizumab and tusamitamab ravtansine (SAR408701) combined with pembrolizumab and platinum-based chemotherapy with or without pemetrexed in patients with CEACAM5-positive expression advanced/metastatic nonsquamous non-small-cell lung cancer (NSQ NSCLC)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509115-84-00

Acronym

ACT16146

Enrollment

Registered

2024-10-15

Start date

2021-05-12

Completion date

2024-12-24

Last updated

2024-12-18

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

Conditions

Cancer

Brief summary

Incidence of study drug-related dose-limiting toxicity (DLTs) at Cycle 1 (C1D1 to C1D21), Expansion part (including participants treated at the recommended dose for expansion [RDE] from the Safety Run-in part): Objective response rate (ORR)

Detailed description

Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory abnormalities according to Common Terminology Criteria for Adverse Events (CTCAE) V5.0, Progression-free survival (PFS), Disease control rate (DCR), Duration of response (DOR), ORR, Pharmacokinetic concentrations, Incidence of anti-therapeutic antibodies (ATAs) against tusamitamab ravtansine

Interventions

DRUGPEMETREXED

DRUGTusamitamab ravtansine

DRUGCISPLATIN

DRUGCARBOPLATIN

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of study drug-related dose-limiting toxicity (DLTs) at Cycle 1 (C1D1 to C1D21), Expansion part (including participants treated at the recommended dose for expansion [RDE] from the Safety Run-in part): Objective response rate (ORR)	—

Secondary

Measure	Time frame
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory abnormalities according to Common Terminology Criteria for Adverse Events (CTCAE) V5.0, Progression-free survival (PFS), Disease control rate (DCR), Duration of response (DOR), ORR, Pharmacokinetic concentrations, Incidence of anti-therapeutic antibodies (ATAs) against tusamitamab ravtansine	—

Countries

France

Outcome results

None listed

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