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Tyrosine Kinase Inhibitor

Experimental treatment arm for Lung Cancer, Non-squamous, Non-small Cell

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 53 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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

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

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My cancer has a specific HER2 mutation.

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I have at least one tumor that can be measured.

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I can be treated with specific chemotherapy and pembrolizumab.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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 appetite domain score

+12 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental treatment armExperimental Treatment1 Intervention

zongertinib only

Group II: Comparator armActive Control4 Interventions

pembrolizumab plus platinum-pemetrexed chemotherapy

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor

2,507 Previous Clinical Trials

11,340,637 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals receiving medical care as part of this research project?

"True. The details on clinicaltrials.gov specify that this investigation is actively seeking volunteers. Initially registered on January 15, 2024, the trial's most recent update was on February 7, 2024. A total of 270 participants are sought from three designated locations."

Answered by AI

Is this clinical trial currently open for enrollment?

"Affirmative. According to details provided on clinicaltrials.gov, this investigation is presently in search of suitable candidates. Originally listed on January 15th, 2024 and most recently revised on February 7th, 2024, the trial aims to enroll a total of 270 participants distributed among three distinct locations."

Answered by AI

What are the safety considerations for patients receiving treatment in the experimental group?

"Scoring a 3 on the safety scale, our team at Power has evaluated the Experimental treatment arm as part of this Phase 3 trial. This score indicates that there is existing efficacy data and robust evidence supporting its safety profile."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "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. https://clinicaltrials.gov/ct2/show/NCT06151574.

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