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A Phase 3, Open-label, Randomized Study of Lazertinib with Subcutaneous Amivantamab Compared with Intravenous Amivantamab in Patients with EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512045-16-00
Acronym
61186372NSC3004
Enrollment
76
Registered
2024-07-19
Start date
2022-08-18
Completion date
Unknown
Last updated
2025-12-05

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

Conditions

EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer

Brief summary

Ctrough of amivantamab: at steady state (Cycle 4 Day 1) for all regions other than EU and others accepting Cycle 2 Day 1 and pre-dose on Cycle 2 Day 1 for EU and any other applicable region, AUCD1-D15 in Cycle 2

Interventions

Sponsors

Janssen Cilag International
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Ctrough of amivantamab: at steady state (Cycle 4 Day 1) for all regions other than EU and others accepting Cycle 2 Day 1 and pre-dose on Cycle 2 Day 1 for EU and any other applicable region, AUCD1-D15 in Cycle 2

Countries

France, Germany, Italy, Poland, Portugal, Spain

Outcome results

None listed

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