← Back to Search

Tyrosine Kinase Inhibitor

Zongertinib for Lung Cancer

Phase 3

Recruiting

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous Non-small cell lung cancer (NSCLC)

Patients who have not received any systemic treatment for locally advanced or metastatic disease

Must not have

Tumors with targetable alterations with approved available therapy

Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 53 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

"This trial is looking for adults with advanced lung cancer who have not yet received chemotherapy. The study aims to see if a new medication called BI 1810631 (zongertinib) can

Who is the study for?

Adults over 18 with advanced non-small cell lung cancer and HER2 mutations, who haven't had systemic therapy for their condition. They must have a tumor that can be measured by scans and be able to receive platinum-based chemotherapy with pembrolizumab.

What is being tested?

The trial is testing if Zongertinib (BI 1810631) is more effective than the standard treatment of pembrolizumab plus platinum-pemetrexed chemotherapy in slowing down advanced lung cancer progression.

What are the potential side effects?

Possible side effects include reactions to infusions, impact on organ functions, fatigue, nausea from chemotherapy, and potential issues related to inhibiting HER2 like diarrhea or skin rashes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My lung cancer is advanced, non-squamous, and not small cell.

Select...

I haven't had any treatment for my advanced or spread cancer.

Select...

My cancer has a specific HER2 mutation.

Select...

I have at least one tumor that can be measured.

Select...

I can be treated with specific chemotherapy and pembrolizumab.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My tumor has changes that can be treated with approved drugs.

Select...

I need to keep taking certain medications that may affect the trial.

Select...

I haven't had, nor plan to have, major surgery like a hip replacement around the trial period.

Select...

I do not have serious heart problems or recent major heart events.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 53 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 53 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 53 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 determined by blinded central independent review

Secondary study objectives

Bi-compartmental PFS, determined by blinded central independent review

Change from baseline to Week 25 in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) physical functioning domain score

Change from baseline to Week 25 in the NSCLC-SAQ pain domain score

+6 more