Poziotinib — drug · CancerIndex

Regulatory

Approvals (0)

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

Data not yet available

No regulatory approval recorded. Absence here is not evidence of absence: only ingested jurisdictions are covered.

What CancerIndex knows

Curated evidence below
Sources

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	Phase 3	Trials	Jurisdictions	First approval	First trial
All cancers	Phase3	Phase 3	1	18	—	—	2009-11
Malignant Lung Neoplasm	Phase3	Phase 3	1	8	—	—	2013-03
Malignant Breast Neoplasm	Phase2	Phase 2	0	6	—	—	2015-04

Computedclinicaltrials

Curated evidence

Clinical evidence (4)

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

civicCuratedShowing 1–4 of 4 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
EGFR M766Q1
Poziotinib	Lung Non-Small Cell Carcinoma

Clinical trials

Trials with this intervention (18)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–18 of 18 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
NCT05378763	A Study of Poziotinib in Previously Treated Participants With Locally Advanced or Metastatic NSCLC Harboring HER2 Exon 20 Mutations(PINNACLE)	suspended	Phase 3	268	Spectrum Pharmaceuticals, IncINDUSTRY	1	Sep 1, 2026	clinicaltrials
NCT03744715	A Study to Allow Continued Dosing and/or Follow-up of Patients Who Have Had Previous Exposure to Poziotinib

ERBB2 Exon 20 Insertion2
Poziotinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	submitted	EID12132 Ninety patients (pre-treated with a median of 2 lines of therapy) with Non-Small Cell Lung Cancer harbouring HER2 exon 20 insertion mutations were treated with poziotinib. The ORR was 27.8% (95% CI, 1… (full text at CIViC) PMID 34843401 · Le et al., 2022 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	submitted	EID12133 Eighty pre-treated patients with Non-Small Cell Lung Cancer harbouring HER2 exon 20 insertions were treated with poziotinib. The ORR Was 39% (95% CI, 28%-50%), and 80% of the patients had a tumour red… (full text at CIViC) PMID 36958688 · Cornelissen et al., 2023 · Open in CIViC	civic