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)
Phase 1NCT04886804
- Population
- Advanced or metastatic HER2-mutant NSCLC; cohorts defined by prior therapy and mutation location
- Design
- Multicohort, open-label phase 1a-1b trial of oral zongertinib in advanced or metastatic HER2-mutant NSCLC. Primary endpoint objective response assessed by blinded independent central review (investigator review in the non-tyrosine kinase domain cohort). Results below are for the 120 mg once-daily dose.
- Primary endpoint
- ORR
- Arms
- Zongertinib 120 mg (experimental): Zongertinib 120 mg orally once daily
- People
- Heymach JV
Show the numbers
| Endpoint | Analysis | Zongertinib 120 mg | Control | Effect |
|---|---|---|---|---|
| ORRCohort 1: previously treated, HER2 tyrosine kinase domain mutation, 120 mg (n=75)Confirmed objective response by blinded independent central review | primaryHeymach 2025 | 71% (60–80%) | — | P<0.001P<0.001 is against a benchmark of 30% or less, as stated in the abstract. Grade 3 or higher drug-related adverse events occurred in 17% of patients. |
| DORCohort 1 (n=75) | primaryHeymach 2025 | median 14.1 months | — | 95% CI 6.9 to not evaluable (upper bound not reported). |
| PFSCohort 1 (n=75) | primaryHeymach 2025 | median 12.4 months | — | 95% CI 8.2 to not evaluable (upper bound not reported). |
| ORRCohort 2: previously untreated, nonsquamous, 120 mg (n=74)Confirmed objective response by blinded independent central review | primaryHeymach 2026 | 76% (65–84%) | — | Grade 3 or higher treatment-related adverse events occurred in 19% of patients. Separate cohort and separate publication from cohort 1. Cohort 2 included 74 previously untreated patients. |
| DORCohort 2 (n=74) | primaryHeymach 2026 | median 15.2 months | — | 95% CI 9.8 to not evaluable (upper bound not reported). |
| PFSCohort 2 (n=74) | primaryHeymach 2026 | median 14.4 months | — | 95% CI 11.1 to not evaluable (upper bound not reported). |
| Endpoint | Analysis | Zongertinib 120 mg | Control | Effect |
|---|---|---|---|---|
| ORRCohort 1: previously treated, HER2 tyrosine kinase domain mutation, 120 mg (n=75)Confirmed objective response by blinded independent central review | primaryHeymach 2025 | 71% (60–80%) | — | P<0.001P<0.001 is against a benchmark of 30% or less, as stated in the abstract. Grade 3 or higher drug-related adverse events occurred in 17% of patients. |
| DORCohort 1 (n=75) | primaryHeymach 2025 | median 14.1 months | — | 95% CI 6.9 to not evaluable (upper bound not reported). |
| PFSCohort 1 (n=75) | primaryHeymach 2025 | median 12.4 months | — | 95% CI 8.2 to not evaluable (upper bound not reported). |
| ORRCohort 2: previously untreated, nonsquamous, 120 mg (n=74)Confirmed objective response by blinded independent central review | primaryHeymach 2026 | 76% (65–84%) | — | Grade 3 or higher treatment-related adverse events occurred in 19% of patients. Separate cohort and separate publication from cohort 1. Cohort 2 included 74 previously untreated patients. |
| DORCohort 2 (n=74) | primaryHeymach 2026 | median 15.2 months | — | 95% CI 9.8 to not evaluable (upper bound not reported). |
| PFSCohort 2 (n=74) | primaryHeymach 2026 | median 14.4 months | — | 95% CI 11.1 to not evaluable (upper bound not reported). |
- Zongertinib 120 mg (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Zongertinib 120 mg |
|---|---|
| 0 | 100.0% |
| 9 | 64.2% |
| 18 | 41.3% |
| 26 | 27.9% |
| 35 | 17.9% |
- Zongertinib 120 mg (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Zongertinib 120 mg |
|---|---|
| 0 | 100.0% |
| 8 | 63.9% |
| 16 | 40.9% |
| 23 | 27.6% |
| 31 | 17.7% |
Appears in
Sources
Heymach JV, Ruiter G, Ahn MJ, Girard N, Smit EF, Planchard D, et al. Zongertinib in Previously Treated HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2025;392(23):2321-2333.
Heymach JV, Yamamoto N, Girard N, Ruiter G, Smit EF, Planchard D, et al. First-Line Zongertinib in Advanced HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2026;394(17):1675-1684.