Zongertinib with or without pembrolizumab and platinum chemotherapy in HER2-mutant NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 study enrolls adults with advanced or metastatic HER2-mutant non-squamous NSCLC who have not yet received systemic therapy for their unresectable or metastatic disease. Participants are randomized to receive zongertinib plus platinum-based chemotherapy, with or without pembrolizumab, given as an infusion and oral tablets, respectively. The trial aims to assess tolerability and safety of the combination regimens, with treatment cycles occurring every 3 weeks for up to 3 months. Eligibility requires confirmed HER2 mutation, measurable disease, and suitability for the planned chemotherapy and pembrolizumab. Lead sponsor is Boehringer Ingelheim, with sites in Australia including Royal North Shore Hospital, Cabrini Health, and Fiona Stanley Hospital.

Why it matters

Who can join: the full rules

Inclusion criteria:

1. 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)
2. Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous non-small cell lung cancer (NSCLC)
3. Documented activating human epidermal growth factor receptor 2 (HER2) mutation as per existing local lab result
4. An archival tumor tissue sample must be submitted to the central laboratory after randomization to retrospectively confirm the HER2 status
5. Patients who have not received any systemic treatment for unresectable, locally advanced or metastatic disease
6. Presence of at least one measurable non-Central Nervous System (CNS) lesion according to response evaluation criteria in solid tumors (RECIST) 1.1
7. Eligible to receive treatment with the selected platinum based doublet chemotherapy and pembrolizumab in accordance with the summary of product characteristics (SmPC)/Product Information
8. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 Further inclusion criteria apply.

Exclusion criteria:

1. Tumors with targetable alterations with approved available therapy
2. Presence or history of leptomeningeal disease
3. 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
4. Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening
5. 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
6. Previous therapy with a HER2-directed agent
7. History or presence of cardiovascular abnormalities which are considered as clinically relevant by the investigator. Myocardial infarction, stroke, or pulmonary embolism within 6 months prior to randomization Further exclusion criteria apply.

Where it's running

• Cabrini Health
  Malvern, Victoria, Australia Recruiting
• Fiona Stanley Hospital
  Murdoch, Western Australia, Australia Recruiting
• Guangdong Provincial People's Hospital
  Guangzhou, China Recruiting
• Shanghai Geriatric Medical Center
  Shanghai, China Recruiting
• CTR Leon Berard
  Lyon, France Recruiting
• INS Curie
  Paris, France Recruiting

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 18002430127

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.