Zongertinib — drug · CancerIndex

Regulatory

Approvals (2)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory2 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2026-02-26 (see label)	approved	Feb 26, 2026	openfda
US FDA	Lung Non-Squamous Non-Small Cell Carcinoma	HERNEXEOS is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test [see Dosage and Administration (2.1) ] . This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. HERNEXEOS is a kinase inhibitor indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test. ( 1 ) This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ( 1 )accelerated	approved	Aug 8, 2025	openfda

Data updated 16 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 3	7	4	2	7	2	US	Aug 8, 2025	Jul 2, 2021
Malignant Lung Neoplasm	Approved	Phase 3	4	2	2	4	1	US	Aug 8, 2025	Jul 2, 2021
Malignant Breast Neoplasm	Phase2	Phase 2	2	1	0	2	0	—	—	Jun 28, 2024
Malignant Esophageal Neoplasm	Phase2	Phase 2	1	1	0	1	0

Curated evidence

Clinical evidence (3)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–3 of 3 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
ERBB2 A775_G776insYVMA1
Zongertinib	Lung Non-Small Cell Carcinoma

Clinical trials

Trials with this intervention (7)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–7 of 7 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT06151574	Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment	active not recruiting	Phase 3	428	Boehringer IngelheimINDUSTRY	26	Sep 22, 2026	clinicaltrials
NCT07195695	Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations