BI 764532 for Small Cell Lung Cancer

Recruiting at 69 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Brain metastases, Pneumonitis, Immunodeficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

174 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have had any other anti-cancer drug within 4 weeks or within 5 half-life periods before starting the trial drug. You also need to be off steroids and anti-epileptic drugs for at least 7 days before starting the trial, unless they are at stable doses.

What is the purpose of this trial?

This study is open to adults with small cell lung cancer and other neuroendocrine tumours. The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find a suitable dose of BI 764532 that people with advanced cancer can tolerate. 2 different doses of BI 764532 are tested in this study. Another purpose is to check whether BI 764532 can make tumours shrink. BI 764532 is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer. The study has 2 parts. In Part 1, participants are put into 2 groups randomly, which means by chance. Participants have an equal chance of being in either group. One group gets dose 1 of BI 764532 and the other group gets dose 2 of BI 764532. In Part 2, all participants receive the same dose of BI 764532. Part 2 is open to people with a certain kind of tumour called extrapulmonary neuroendocrine carcinoma. All participants receive BI 764532 as an infusion into a vein when starting treatment. If there is benefit for the participants and if they can tolerate it, the treatment is given up to the maximum duration of the study. During this time, participants visit the study site regularly. The total number of visits depends on how they respond to and tolerate the treatment. The first study visits include an overnight stay to monitor participants´ safety. Doctors record any unwanted effects and regularly check the general health of the participants.

Eligibility Criteria

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.

Inclusion Criteria

My cancer is primarily neuroendocrine or small cell lung cancer.

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

All my side effects from past cancer treatments are mild, except for hair loss, nerve pain, or menstrual changes.

Exclusion Criteria

I haven't taken immunosuppressive drugs or steroids, except for replacement, in the last 7 days.

Unresolved toxicity from prior anti-tumour therapy, defined as per protocol

I had a severe reaction to immune therapy that stopped my treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants are randomly assigned to receive one of two doses of BI 764532 as an infusion. The first study visits include an overnight stay to monitor participants' safety.

up to 26 months

Regular visits with overnight stay initially

Treatment Part 2

All participants receive the same dose of BI 764532. This phase is open to people with extrapulmonary neuroendocrine carcinoma.

up to 27 months

Regular visits

Follow-up

Participants are monitored for safety and effectiveness after treatment. Doctors record any unwanted effects and regularly check the general health of the participants.

4-8 weeks

Treatment Details

Interventions

• BI 764532

Trial Overview 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.

Participant Groups

Group I: Part 2: Expansion cohort Experimental Treatment 1 Intervention

Group II: Part 1: Dose group 2 Experimental Treatment 1 Intervention

Group III: Part 1: Dose group 1 Experimental Treatment 1 Intervention

BI 764532 is already approved in United States for the following indications:

Approved in United States as BI 764532 for:

• None approved; under investigation for extensive-stage small cell lung cancer (ES-SCLC) and extrapulmonary neuroendocrine carcinoma (epNEC)

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+