NCT04886804

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built. Commentary is thin so far, so the report would be short.

Official title

Beamion LUNG-1: An Open Label, Phase I Dose Escalation Trial, With Dose Confirmation and Expansion, of Zongertinib (BI 1810631) as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations

Phase

Phase 1

Status

Active not recruiting

Conditions

Neoplasm Metastasis; Non-Small Cell Lung Cancer

Interventions

zongertinib

Arms

• Phase Ia - Dose escalation part · Experimental
• Phase Ib - Dose expansion part: Cohort 1 · Experimental
• Phase Ib - Dose expansion part: Cohort 2 · Experimental
• Phase Ib - Dose expansion part: Cohort 3 · Experimental
• Phase Ib - Dose expansion part: Cohort 4 · Experimental
• Phase Ib - Dose expansion part: Cohort 5 · Experimental
• Phase Ib - Dose expansion part: Cohort 6 · Experimental
• Phase Ib - Dose expansion part: Cohort 7 · Experimental
• Phase Ib - Dose expansion part: Cohort 8 · Experimental
• Phase Ib - Dose expansion part: Cohort 9 · Experimental

Enrollment

554 (estimated)

Primary outcomes

• Phase Ia: Maximum Tolerated Dose (MTD)
• Phase Ia: Number of patients with Dose Limiting Toxicities (DLTs) in the MTD evaluation period
• Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Objective response (OR) as assessed by central independent review
• Phase Ib - Cohorts 3 (patients prior to CTP v8.0), 6, 7, 8, and 9: Objective response according to RECIST 1.1 by investigator assessment
• Phase Ib: Cohort 4: Objective response according to Response Assessment in Neuro-Oncology for Brain Metastases (RANO-BM) by central independent review

Sponsor

Boehringer Ingelheim

Start

Jul 2, 2021

Primary completion

Dec 30, 2026 (estimated)

Results posted

No

Registry record

NCT04886804 · updated Oct 5, 2026

• Heymach JV, Yamamoto N, Girard N, Ruiter G, Smit EF, Planchard D, Nadal E, Wu YL, Zugazagoitia J, Tu HY, Baik CS, Yoh K, Soo RA, Zhao Y, Sabari JK, Wermke M, Scheffler M, Ahn MJ, Fernamberg K, Schroeter L, Sadrolhefazi B, Thamer C, Eigenbrod-Giese S, Popat S; Beamion LUNG-1 Investigators. First-Line Zongertinib in Advanced HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2026 Apr 30;394(17):1675-1684. doi: 10.1056/NEJMoa2516969. Epub 2026 Apr 15. PubMed 41985129
• Heymach JV, Ruiter G, Ahn MJ, Girard N, Smit EF, Planchard D, Wu YL, Cho BC, Yamamoto N, Sabari JK, Zhao Y, Tu HY, Yoh K, Nadal E, Sadrolhefazi B, Rohrbacher M, von Wangenheim U, Eigenbrod-Giese S, Zugazagoitia J; Beamion LUNG-1 Investigators. Zongertinib in Previously Treated HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2025 Jun 19;392(23):2321-2333. doi: 10.1056/NEJMoa2503704. Epub 2025 Apr 28. PubMed 40293180
• Heymach JV, Opdam F, Barve M, Tu HY, Wu YL, Berz D, Schroter L, Botilde Y, Sadrolhefazi B, Serra J, Yoh K, Yamamoto N. HER2-Selective Tyrosine Kinase Inhibitor, Zongertinib (BI 1810631), in Patients With Advanced/Metastatic Solid Tumors With HER2 Alterations: A Phase Ia Dose-Escalation Study. J Clin Oncol. 2025 Apr 10;43(11):1337-1347. doi: 10.1200/JCO-24-01727. Epub 2025 Mar 3. PubMed 40030100
• Heymach J, Opdam F, Barve M, Gibson N, Sadrolhefazi B, Serra J, Yamamoto N. A Phase I, Open-Label, Dose Confirmation, Escalation, and Expansion Trial of BI 1810631 as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations. Clin Lung Cancer. 2023 Mar;24(2):e65-e68. doi: 10.1016/j.cllc.2022.10.008. Epub 2022 Nov 11. PubMed 36528522