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AFAMOSI: Prospective, randomized, multicenter Phase IV study to evaluate the efficacy and safety of afatinib followed by osimertinib compared to osimertinib in patients with EGFRmutated/T790M Mutation negative non-squamous NSCLC in the first-line setting

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511625-55-00
Acronym
AFAMOSI
Enrollment
126
Registered
2024-06-21
Start date
2022-11-30
Completion date
Unknown
Last updated
2025-12-12

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

Conditions

EGFRmutated/T790M Mutation negative non-squamous NSCLC

Brief summary

Time to EGFR-TKI failure within 24 months for afatinib followed by osimertinib in T790Mpositive group vs osimertinib

Detailed description

Time to EGFR-TKI failure (afatinib versus osimertinib), Progression-free survival (PFS: afatinib followed by osimertinib or ICT vs osimertinib followed by ICT), Overall Survival (OS), Response Rate (RR) at 12 months and 24 months, Disease Control Rate (DCR) at 12 months and 24 months, Safety and Tolerability, Symptom control assessed by patient-reported quality of life (QoL) with EQ-5D, EORTC QLQ-C30, EORTC QLQ-LC29

Interventions

DRUGGIOTRIF 40 mg film-coated tablets
DRUGTAGRISSO 80 mg film-coated tablets
DRUGTAGRISSO 40 mg film-coated tablets
DRUGGIOTRIF 30 mg film-coated tablets
DRUGGIOTRIF 20 mg film-coated tablets

Sponsors

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Time to EGFR-TKI failure within 24 months for afatinib followed by osimertinib in T790Mpositive group vs osimertinib—

Secondary

MeasureTime frame
Time to EGFR-TKI failure (afatinib versus osimertinib), Progression-free survival (PFS: afatinib followed by osimertinib or ICT vs osimertinib followed by ICT), Overall Survival (OS), Response Rate (RR) at 12 months and 24 months, Disease Control Rate (DCR) at 12 months and 24 months, Safety and Tolerability, Symptom control assessed by patient-reported quality of life (QoL) with EQ-5D, EORTC QLQ-C30, EORTC QLQ-LC29—

Countries

Germany

Outcome results

None listed

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