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Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan Compared to Standard of Care in Subjects with Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI - AndroMETa-Lung-713

Status
Not yet recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521124-29-00
Enrollment
25
Registered
2026-02-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-10

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

Brief summary

Phase 2: Objective Response (OR) Assessed by Blinded Independent Central Review (BICR), Phase 3: Progression-Free Survival (PFS) as assessed by BICR

Detailed description

Phase 2 and 3: Overall Survival (OS) as assessed by BICR, Phase 2: PFS as assessed by BICR, Phase 2 and 3: Duration of Response (DoR) as Assessed by the BICR per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, Phase 2 and 3: Disease Control (DC) as Assessed by the BICR per RECIST v1.1, Phase 3: OR Assessed by BICR, Phase 3: Percentage of Participants with Change from Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), Phase 3: Percentage of Participants with Change from Baseline in Key Lung Cancer Symptoms as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQLC13), Phase 3: Percentage of Participants with Change from Baseline in GHS/QoL as measured by the EORTC QLQ-C30, Phase 3: Percentage of Participants with Change from Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)

Interventions

DRUGOSIMERTINIB
DRUGPEMETREXED
DRUGCISPLATIN
DRUGCARBOPLATIN
DRUGAMIVANTAMAB

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) Assessed by Blinded Independent Central Review (BICR), Phase 3: Progression-Free Survival (PFS) as assessed by BICR

Secondary

MeasureTime frame
Phase 2 and 3: Overall Survival (OS) as assessed by BICR, Phase 2: PFS as assessed by BICR, Phase 2 and 3: Duration of Response (DoR) as Assessed by the BICR per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, Phase 2 and 3: Disease Control (DC) as Assessed by the BICR per RECIST v1.1, Phase 3: OR Assessed by BICR, Phase 3: Percentage of Participants with Change from Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), Phase 3: Percentage of Participants with Change from Baseline in Key Lung Cancer Symptoms as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQLC13), Phase 3: Percentage of Participants with Change from Baseline in GHS/QoL as measured by the EORTC QLQ-C30, Phase 3: Percentage of Participants with Change from Baseline in Physical Functioning as Measured by th

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 11, 2026