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Monoclonal Antibodies

BI 764532 for Small Cell Lung Cancer

Phase 2

Recruiting

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

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

Must have

Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Histologically or cytologically confirmed, cancer of the following histologies: Small cell lung cancer (SCLC), Extra-pulmonary neuroendocrine carcinoma (epNEC) (except Merkel cell carcinoma (MCC), Medullary thyroid cancer (MTC) and Neuroendocrine prostate cancer (NEPC)), Large cell neuroendocrine carcinoma (LCNEC) of the lung. Patients with tumours with mixed histologies for any above type are eligible only if the neuroendocrine carcinoma/small tumour cells component is predominant and represents at least 50% of the overall tumour tissue

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 23 months

Awards & highlights

Study Summary

This trial is for adults with advanced small-cell lung cancer & neuroendocrine tumours. It tests 2 doses of BI 764532, an antibody-like molecule, to see if it shrinks tumours & is safe & tolerable. Participants visit the study site regularly to monitor safety & record effects.

Who is the study for?

Adults with advanced small cell lung cancer or neuroendocrine tumors, who have had unsuccessful prior treatments or no standard treatment options. Participants must be over 18, have measurable lesions, provide consent, and agree to use effective birth control. They should not have severe allergies to immuno-oncology agents or certain lung conditions.Check my eligibility

What is being tested?

The trial is testing two different doses of BI 764532, an experimental antibody-like molecule designed to help the immune system fight cancer. Patients are randomly assigned to receive one of the two doses via vein infusion and monitored for tumor response and tolerability.See study design

What are the potential side effects?

While specific side effects are not listed here, participants will be closely monitored for any unwanted effects during their regular visits which include an initial overnight stay. Side effects could range from mild reactions at the infusion site to more serious immune-related issues.

Eligibility Criteria

Inclusion Criteria

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

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I have signed and understand the consent form for this trial.

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My cancer is primarily neuroendocrine or small cell lung cancer.

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My small cell lung cancer has worsened after two treatments, including a platinum-based one.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have a stored sample of my tumor tissue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 23 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 23 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 23 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

Objective response (OR), defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR)

Occurrence of treatment-emergent adverse events (TEAEs) during the on-treatment period

Secondary outcome measures

Change from baseline in EORTC QLQ-C30 physical functioning domain score

Change from baseline in EORTC QLQ-C30 role functioning domain score

Disease control (DC), defined as best overall response of CR or PR or stable disease (SD) based on investigator assessment

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose group 2Experimental Treatment1 Intervention

Group II: Dose group 1Experimental Treatment1 Intervention

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor

2,507 Previous Clinical Trials

11,340,787 Total Patients Enrolled

Frequently Asked Questions

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

How many individuals have joined the research endeavor?

"Affirmative. The information publicly available on clinicaltrials.gov indicates that this medical study, which was made public on September 25th 2023, is currently recruiting patients to join the trial. A total of 120 individuals are expected to be recruited over 19 different sites for the study's duration."

Answered by AI

Is the enrollment period for this medical trial still accepting participants?

"This research project is actively accruing participants, as noted on clinicaltrials.gov - the study was initially advertised to potential patients on September 25th 2023 and has since been updated most recently on November 17th of that same year."

Answered by AI

How numerous are the locations that have been enlisted to conduct this research study in city?

"Currently, 19 trial sites are enrolling patients for this study. These locations range from Los Angeles to Indianapolis to Jinan and other cities spread across the globe. It is critical to select nearby location if you join so that travelling costs can be minimized."

Answered by AI