NCT07486817

Brief Summary

This study is open to adults with a type of lung cancer called HER2-mutant non-squamous non-small cell lung cancer (NSCLC) that is advanced or has spread. People who have a tumor with a HER2 mutation and have not received previous treatment for their lung cancer can participate in the study. The purpose of this study is to find out how well a medicine called zongertinib is tolerated in people with this type of lung cancer, when combined with chemotherapy, with or without pembrolizumab. Zongertinib works by targeting and blocking HER2, a protein involved in cancer cell growth. Participants are put into two groups randomly, which means by chance. One group gets zongertinib tablets combined with platinum-based chemotherapy. The other group gets the same treatment plus an additional medicine called pembrolizumab. Chemotherapy and pembrolizumab are given as an infusion into a vein. Participants take zongertinib by mouth once a day, while chemotherapy is given every 3 weeks for up to 3 months, followed by maintenance treatment for up to 2 years. Pembrolizumab is given every 3 weeks for up to 2 years. This study does not have a fixed duration. Participants can receive some of the study treatments for up to about 2 years and may continue to take zongertinib as long as they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. Doctors regularly check the size of the tumor and whether it has spread. They also monitor participants' health and take note of any unwanted effects.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
39mo left

Started Jun 2026

Typical duration for phase_2

Geographic Reach
7 countries

17 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Jun 2026Aug 2029

First Submitted

Initial submission to the registry

March 12, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 4, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2029

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

1.2 years

First QC Date

March 12, 2026

Last Update Submit

June 11, 2026

Conditions

Lung Cancer, Non-squamous, Non-small Cell

Outcome Measures

Primary Outcomes (1)

  • Occurrence of discontinuation and/or prolonged interruption (>7 days) of zongertinib due to treatment-related adverse events (AEs) in the first 2 cycles of treatment

    up to 6 weeks

Secondary Outcomes (10)

  • Occurrence of serious adverse events (SAE) during the on-treatment period

    up to 1.5 years

  • Occurrence of dose reduction of zongertinib

    up to 1.5 years

  • Occurrence of discontinuation and/or prolonged interruption (>7 days) of zongertinib due to treatment-related AEs during the on-treatment period

    up to 1.5 years

  • Occurrence of Grade ≥3 non-hematological AE during the on-treatment period

    up to 1.5 years

  • Occurrence of combination limiting toxicities (CLTs) during the on-treatment period

    up to 1.5 years

  • +5 more secondary outcomes

Study Arms (2)

Arm A: zongertinib + cisplatin or carboplatin and pemetrexed

EXPERIMENTAL
Drug: ZongertinibDrug: CisplatinDrug: CarboplatinDrug: Pemetrexed

Arm B: zongertinib + cisplatin or carboplatin and pemetrexed with pembrolizumab

EXPERIMENTAL
Drug: ZongertinibDrug: CisplatinDrug: CarboplatinDrug: PemetrexedDrug: Pembrolizumab

Interventions

ZongertinibDRUG

Zongertinib

Also known as: Hernexeos®
Arm A: zongertinib + cisplatin or carboplatin and pemetrexedArm B: zongertinib + cisplatin or carboplatin and pemetrexed with pembrolizumab
CisplatinDRUG

Cisplatin

Arm A: zongertinib + cisplatin or carboplatin and pemetrexedArm B: zongertinib + cisplatin or carboplatin and pemetrexed with pembrolizumab
CarboplatinDRUG

Carboplatin

Arm A: zongertinib + cisplatin or carboplatin and pemetrexedArm B: zongertinib + cisplatin or carboplatin and pemetrexed with pembrolizumab
PembrolizumabDRUG

Pembrolizumab

Arm B: zongertinib + cisplatin or carboplatin and pemetrexed with pembrolizumab
PemetrexedDRUG

Pemetrexed

Arm A: zongertinib + cisplatin or carboplatin and pemetrexedArm B: zongertinib + cisplatin or carboplatin and pemetrexed with pembrolizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the informed consent form (ICF)
  • Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous non-small cell lung cancer (NSCLC)
  • Documented activating human epidermal growth factor receptor 2 (HER2) mutation as per existing local lab result
  • An archival tumor tissue sample must be submitted to the central laboratory after randomization to retrospectively confirm the HER2 status
  • Patients who have not received any systemic treatment for unresectable, locally advanced or metastatic disease
  • Presence of at least one measurable non-Central Nervous System (CNS) lesion according to response evaluation criteria in solid tumors (RECIST) 1.1
  • Eligible to receive treatment with the selected platinum based doublet chemotherapy and pembrolizumab in accordance with the summary of product characteristics (SmPC)/Product Information

You may not qualify if:

  • Tumors with targetable alterations with approved available therapy
  • Presence or history of leptomeningeal disease
  • Radiotherapy within 4 weeks prior to treatment start with exception of palliative radiotherapy to regions other than the chest if completed at least 2 weeks prior to treatment start
  • Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening
  • Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the trial or interfere with the evaluation of the safety and efficacy of the test drug
  • Previous therapy with a HER2-directed agent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

NOT YET RECRUITING

Cabrini Health

Malvern, Victoria, 3144, Australia

NOT YET RECRUITING

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

NOT YET RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, 510080, China

NOT YET RECRUITING

Shanghai Geriatric Medical Center

Shanghai, 201104, China

NOT YET RECRUITING

CTR Leon Berard

Lyon, 69373, France

NOT YET RECRUITING

INS Curie

Paris, 75005, France

NOT YET RECRUITING

Universitätsklinikum Köln (AöR)

Cologne, 50937, Germany

NOT YET RECRUITING

Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

Heidelberg, 69126, Germany

NOT YET RECRUITING

Kindai University Hospital

Osaka, Sakai, 590-0197, Japan

NOT YET RECRUITING

National Cancer Center Hospital

Tokyo, Chuo-ku, 104-0045, Japan

NOT YET RECRUITING

Severance Hospital

Seoul, 03722, South Korea

NOT YET RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

NOT YET RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

NOT YET RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

NOT YET RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Virgen del Rocío

Seville, 41013, Spain

NOT YET RECRUITING

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Interventions

CisplatinCarboplatinPemetrexedpembrolizumab

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCoordination ComplexesOrganic ChemicalsGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Central Study Contacts

Boehringer Ingelheim

CONTACT

18002430127clintriage.rdg@boehringer-ingelheim.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 23, 2026

Study Start

June 4, 2026

Primary Completion (Estimated)

August 12, 2027

Study Completion (Estimated)

August 25, 2029

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Locations

CN(2)JP(2)KR(3)ES(3)AU(3)FR(2)DE(2)