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A Phase 2/3 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination with Osimertinib as First-Line Treatment in Patients with Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518586-10-00
Acronym
M25-287
Enrollment
44
Registered
2025-08-25
Start date
2025-09-18
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Brief summary

Phase 2: Objective response (OR) based on Blinded independent central review (BICR) assessment per RECIST version 1.1, Phase 3: Progression-free survival (PFS) based on BICR assessment per RECIST version 1.1.

Detailed description

Phase 2: PFS based on BICR assessment per RECIST version 1.1., Phase 2: Duration of response (DoR) based on BICR assessment per RECIST version 1.1., Phase 2: Disease control rate (DC) based on BICR assessment per RECIST version 1.1., Phase 2: Overall Survival, Phase 3: Overall Survival, Phase 3: OR based on BICR assessment per RECIST version 1.1., Phase 3: DoR based on BICR assessment per RECIST version 1.1., Phase 3: DC based on BICR assessment per RECIST version 1.1., Phase 3: Change from baseline at Week 12 in physical functioning as measured by the EORTC QLQ‑C30, Phase 3: Change from baseline at Week 12 in key lung cancer symptoms as measured by the EORTC QLQ-LC13., Phase 3: Change from baseline at Week 12 in GHS/QoL as measured by the EORTC QLQ-C30.

Interventions

DRUGOSIMERTINIB

Sponsors

AbbVie Deutschland GmbH & Co. KG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Phase 2: Objective response (OR) based on Blinded independent central review (BICR) assessment per RECIST version 1.1, Phase 3: Progression-free survival (PFS) based on BICR assessment per RECIST version 1.1.

Secondary

MeasureTime frame
Phase 2: PFS based on BICR assessment per RECIST version 1.1., Phase 2: Duration of response (DoR) based on BICR assessment per RECIST version 1.1., Phase 2: Disease control rate (DC) based on BICR assessment per RECIST version 1.1., Phase 2: Overall Survival, Phase 3: Overall Survival, Phase 3: OR based on BICR assessment per RECIST version 1.1., Phase 3: DoR based on BICR assessment per RECIST version 1.1., Phase 3: DC based on BICR assessment per RECIST version 1.1., Phase 3: Change from baseline at Week 12 in physical functioning as measured by the EORTC QLQ‑C30, Phase 3: Change from baseline at Week 12 in key lung cancer symptoms as measured by the EORTC QLQ-LC13., Phase 3: Change from baseline at Week 12 in GHS/QoL as measured by the EORTC QLQ-C30.

Countries

Belgium, Italy, Portugal, Spain

Outcome results

None listed

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