# HER2 (NCT05099172)

> First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2)

No report yet. It can be ordered.

## Registry

- Registry record: https://clinicaltrials.gov/study/NCT05099172
- Phase: PHASE1, PHASE2
- Status: RECRUITING
- Sponsor: Bayer
- Conditions: Advanced Non-small Cell Lung Cancer; EGFR Mutation; HER2 Mutation
- Interventions: BAY2927088_formulation A; BAY2927088_formulation B_1; BAY2927088_formulation B_2; BAY2927088_formulation B_3
- Enrollment: 430
- Primary outcome: Number of participants with treatment-emergent adverse events (TEAEs)
- Primary outcome: Number of participants with treatment-emergent serious adverse events (TESAEs)
- Primary outcome: Severity of TEAEs
- Primary outcome: Severity of TESAEs
- Primary outcome: Number of participants who discontinue study treatment due to an AE
- Primary outcome: Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BAY2927088 within the DLT observation period in Dose Escalation (including participants from Backfill qualifying for the MTD population)
- Primary outcome: Number of participants experiencing dose-limiting toxicities (DLTs) at each dose level associated with administration of BAY2927088 in the DLT observation period in Dose Escalation (including participants from Backfill)
- Primary outcome: Cmax of BAY2927088
- Primary outcome: AUC(0-24) of BAY2927088 for QD
- Primary outcome: AUC(0-12) of BAY2927088 for BID
- Primary outcome: Cmax,md of BAY2927088
- Primary outcome: AUC(0-24)md of BAY2927088 for QD
- Primary outcome: AUC(0-12)md of BAY2927088 for BID
- Primary outcome: Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) by blinded independent central review (BICR) in extension part

## Indexed commentary on HER2 so far

Podcasts, YouTube videos and X posts we have indexed that name the trial. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.

- X threads: 10
- Bluesky threads: 1

## Order

Standard, $1,250, price fixed at order: https://www.erudio.com/contact?report=her2-nct05099172

## Free preview

POST https://www.erudio.com/api/trial-requests with {"nct_id": "NCT05099172", "email": "<work email>"}; the inbox owner confirms by the emailed link.