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BEAMION Lung-2: A Phase III, open-label, randomized, activecontrolled, multi-centre trial evaluating orally administered zongertinib (BI 1810631) compared with standard of care as first-line treatment in patients with unresectable, locally advanced or metastatic nonsquamous non-small cell lung cancer harbouring HER2 tyrosine kinase domain mutations

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504308-27-00
Acronym
1479-0008
Enrollment
121
Registered
2024-03-05
Start date
2024-06-06
Completion date
Unknown
Last updated
2025-11-13

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

The primary endpoint is PFS according to RECIST 1.1 determined by blinded central independent review.

Detailed description

The key secondary endpoints are OR according to RECIST 1.1, determined by blinded central independent review, the change from baseline to Week 25 of NSCLC-SAQ total score, and OS., Duration of response (DoR), determined by blinded central independent review., Progression free survival, determined by blinded central independent review., Bi-compartmental PFS, determined by blinded central independent review., Overall response, determined by blinded central independent review., Further patient reported outcomes (PROs) from NSCLC-SAQ and EORTC QLQ-C30 domain scores, analyzed as change from baseline to Week 25, Occurrence of AEs during the on-treatment period, graded according to CTCAE version 5.0., Occurrence of serious AEs (SAEs) during the on-treatment period, graded according to CTCAE version 5.0.

Interventions

DRUGBI 1810631
DRUGALIMTA 500 mg powder for concentrate for solution for infusion
DRUGCarboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGCisplatin Hikma 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Sponsors

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint is PFS according to RECIST 1.1 determined by blinded central independent review.—

Secondary

MeasureTime frame
The key secondary endpoints are OR according to RECIST 1.1, determined by blinded central independent review, the change from baseline to Week 25 of NSCLC-SAQ total score, and OS., Duration of response (DoR), determined by blinded central independent review., Progression free survival, determined by blinded central independent review., Bi-compartmental PFS, determined by blinded central independent review., Overall response, determined by blinded central independent review., Further patient reported outcomes (PROs) from NSCLC-SAQ and EORTC QLQ-C30 domain scores, analyzed as change from baseline to Week 25, Occurrence of AEs during the on-treatment period, graded according to CTCAE version 5.0., Occurrence of serious AEs (SAEs) during the on-treatment period, graded according to CTCAE version 5.0.—

Countries

Austria, Belgium, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden

Outcome results

None listed

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