Lung Cancer, Non Squamous, Non Small Cell / Cisplatin / Carboplatin · Phase 3 Trial

Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

ClinicalTrials.gov · August 20, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 3 randomized trial registration comparing zongertinib to pembrolizumab plus platinum-pemetrexed chemotherapy in treatment-naive adults with advanced non-small cell lung cancer bearing HER2 mutations. The study is actively enrolling with a primary endpoint of progression-free survival by RECIST 1.1 at blinded central review; no results are yet reported in this registry record.

What was studied

Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Lung Cancer, Non-squamous, Non-small Cell; age from 18 Years. Intervention: Experimental treatment arm. Compared with: Comparator arm — Active Comparator. n = 428. 163 sites across 26 countries.

Key findings

Safety

This is a registry record only; no efficacy or safety results are reported

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 3 RCT registration with no results posted; the study is active but not yet recruiting and outcomes have not been reported, making it a planned trial rather than evidence of efficacy.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 determined by blinded central independent review (assessed at up to 4 years and 5 months)

DesignPhase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose

PopulationLung Cancer, Non-squamous, Non-small Cell; age from 18 Years

Sample size428

InterventionExperimental treatment arm

ComparatorComparator arm — Active Comparator

Setting163 sites across 26 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment428

PhasePHASE 3

Primary outcome measureProgression-free survival (PFS) according to RECIST 1.1 determined by blinded central independent review, up to 4 years and 5 months

Maximum study duration70 months

Caveats

This is a registry record only; no efficacy or safety results are reported
Treatment arm is open-label, limiting blinding; control arm received standard chemotherapy
Primary endpoint timeframe extends to 4 years 5 months; interim or final efficacy data are not posted in this record
Generalizability limited to HER2-mutant, treatment-naive non-squamous NSCLC

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Phase 3, randomized, blinded central review of primary endpoint

Directness

strong

Directly compares zongertinib to standard-of-care in target population

Consistency

insufficient

No results reported; consistency cannot be assessed

Risk of bias

moderate

Blinded central review mitigates bias; open-label treatment arm limits blinding

Sample adequacy

strong

Planned enrollment 428 participants; adequate for Phase 3 primary endpoint

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06151574). This is a study registration, not published results. Lead sponsor: Boehringer Ingelheim. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 428 participants (ACTUAL). Conditions: Lung Cancer, Non-squamous, Non-small Cell. Interventions: DRUG: zongertinib; DRUG: pembrolizumab; DRUG: cisplatin; DRUG: carboplatin; DRUG: pemetrexed. Primary outcome measures: Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 determined by blinded central independent review , up to 4 years and 5 months. Brief summary: This study is open to adults 18 years and older with advanced or metastatic non-small cell lung cancer. People can join the study if they have tumours with HER2 mutations and have not yet received any systemic therapy including chemotherapy for advanced or metastatic lung cancer. The purpose of this study is to find out whether a medicine called zongertinib (BI 1810631) can slow down the worsening of advanced non-small cell lung cancer better than the standard treatment available. Zongertinib may slow cancer cell growth by inhibiting HER2. This would prolong cancer re-occurrence and increase survival. Current standard treatment is pembrolizumab plus platinum-pemetrexed chemotherapy. Participants are put into 2 groups by chance. One group receives zongertinib at regular times throughout the study and the other group receives infusions of pembrolizumab, pemetrexed and cisplatin or carboplatin (pembrolizumab plus platinum-pemetrexed chemotherapy) into a vein. Participants may be in the study up to a maximum of 70 months. During this time, they visit the study site about every 3 weeks for study procedures. The doctors regularly check the size of the tumour with a CT or MRI scan, at the beginning of the study and every 6 weeks. After 18 months they check the tumour size every 12 weeks. Doctors regularly check whether the cancer has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects. The time it takes for the cancer to worsen is compared between the 2 groups to see whether the treatment works. The participants also fill in questionnaires about their symptoms and quality of life.

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Lung Cancer, Non Squamous, Non Small CellCisplatinBoehringer IngelheimNCT06151574Carboplatin