Erudio Healtherudio.com
Clinical trial · no report yet · Phase 1
Beamion LUNG-1
Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)
- NCT04886804 ↗
- Recruiting
- Boehringer Ingelheim
- Deep
We haven't built an HCP commentary report on Beamion LUNG-1 (zongertinib in Neoplasm Metastasis) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on Beamion LUNG-1 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 82 | |
| YouTube | 15 | |
| Podcasts | 12 | |
| Bluesky threads | 5 | |
| X videos | 1 |
The trial
ClinicalTrials.gov- 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
- 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
- Feb 29, 2028 (estimated)
- Results posted
- No
- Registry record
- NCT04886804 · updated Oct 28, 2026
Publications
linked from the registry- 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