What is the mechanism of action of this treatment?

The most common treatments for lung cancer include chemotherapy, targeted therapy, immunotherapy, and radiation. Chemotherapy works by killing rapidly dividing cells, including cancer cells. Targeted therapies, such as EGFR inhibitors and ALK inhibitors, block specific molecules involved in cancer cell growth and survival. Immunotherapies, like PD-1/PD-L1 inhibitors, enhance the immune system's ability to recognize and destroy cancer cells. Radiation therapy uses high-energy rays to kill cancer cells. MDM2 inhibitors, like BI 907828, work by blocking the MDM2 protein, which normally inhibits the tumor suppressor p53, thereby allowing p53 to induce cancer cell death. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the cancer's specific characteristics and the patient's overall health.

What side effects are associated with this type of intervention?

Common treatments for lung cancer include chemotherapy, immunotherapy, and targeted therapies. Chemotherapy agents like docetaxel and pemetrexed can cause side effects such as neutropenia, fatigue, nausea, and increased risk of infection. Immunotherapy drugs like pembrolizumab and atezolizumab may lead to immune-related adverse events, including pneumonitis, colitis, and hepatitis. Targeted therapies, such as those inhibiting EGFR or ALK, can cause rash, diarrhea, and liver function abnormalities. While specific side effects of MDM2 inhibitors like BI 907828 are not detailed, they may share similar adverse effects with other targeted therapies, including gastrointestinal disturbances and hematologic toxicities.

What prior FDA approvals exist?

The FDA has approved several treatments for advanced lung cancer, particularly focusing on targeted therapies and immunotherapies. Notable approvals include pembrolizumab and atezolizumab, which are immune checkpoint inhibitors targeting PD-1 and PD-L1, respectively. These drugs have shown significant improvements in overall survival and progression-free survival in various subtypes of non-small cell lung cancer (NSCLC). Additionally, targeted therapies like sotorasib and adagrasib have been approved for KRAS G12C-mutated NSCLC. While MDM2 inhibitors like BI 907828 are still under investigation, these approved treatments highlight the ongoing advancements in targeted and immunotherapy for lung cancer.

What other types of research exist?

Promising novel alternatives to BI 907828 for lung cancer patients include: 1) Triple therapy with trastuzumab, pertuzumab, and docetaxel for HER2-mutated advanced NSCLC, 2) MB02 (bevacizumab biosimilar) in combination with carboplatin and paclitaxel for advanced non-squamous NSCLC, 3) Ganetespib combined with docetaxel for advanced lung adenocarcinoma, and 4) Dacomitinib for NSCLC harboring the rare delE709_T710insD mutation.

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MDM2 Inhibitor

Brigimadlin for Solid Cancers

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

Cohort 3 (lung adenocarcinoma): Locally advanced or metastatic lung adenocarcinoma. Patients must have unresectable disease and have received all available conventional therapies known to confer clinical benefit for their disease based on local approved standards.

Diagnosis of a solid tumour meeting the criteria for an open trial cohort

Must not have

Previous administration of brigimadlin (BI 907828) or any other MDM2-p53 or MDMX-p53 antagonist

Active bleeding, significant risk of haemorrhage, or current bleeding disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 50 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a medicine called BI 907828 for adults with advanced cancer in the biliary tract, pancreas, lung, or bladder who have no other treatment options. The medicine is taken as a tablet periodically and works by blocking a protein that helps cancer cells grow.

Who is the study for?

Adults with advanced biliary tract, pancreatic, lung (adenocarcinoma), or bladder cancer who have tried all other treatments without success or for whom no treatment exists. Participants must have a specific genetic profile (MDM2 amplification and TP53 wild-type) in their tumors, be able to take oral medication every three weeks, and commit to regular health checks at the study site.

What is being tested?

The trial is testing Brigimadlin (BI 907828), an MDM2 inhibitor taken as a tablet once every three weeks by patients with certain advanced cancers. The goal is to see if it can shrink tumors or stop them from spreading. Patients can continue taking the drug as long as they benefit from it and tolerate its effects.

What are the potential side effects?

While not explicitly listed in the provided information, side effects of MDM2 inhibitors like Brigimadlin may include nausea, vomiting, diarrhea, fatigue, blood count changes that could increase infection risk or cause bruising/bleeding easily. Regular monitoring will help identify any unwanted effects.

Eligibility Criteria

Inclusion Criteria

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

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I have advanced lung adenocarcinoma and have tried all standard treatments.

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My solid tumor qualifies for a specific trial group.

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My cancer has MDM2 amplification and normal TP53 according to tests.

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I can provide tissue samples for cancer gene testing.

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I am fully active or can carry out light work.

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All side effects from my previous cancer treatments are mild.

Exclusion Criteria

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

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I have never taken brigimadlin or similar drugs targeting MDM2-p53 or MDMX-p53.

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I am currently experiencing bleeding or have a high risk of bleeding.

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I haven't had major surgery in the last 4 weeks and don't plan any in the next 6 months.

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I do not have any other cancers that could affect this trial's results.

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I am not taking any medications that could affect the trial's safety.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 50 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 50 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 50 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

Objective response (OR)

Secondary study objectives

Change from baseline in EORTC QLQ-BIL21 tiredness domain score

Change from baseline in EORTC QLQ-C30 fatigue domain score

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

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: brigimadlin (BI 907828) treatment armExperimental Treatment1 Intervention

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for lung cancer include chemotherapy, targeted therapy, immunotherapy, and radiation. Chemotherapy works by killing rapidly dividing cells, including cancer cells. Targeted therapies, such as EGFR inhibitors and ALK inhibitors, block specific molecules involved in cancer cell growth and survival. Immunotherapies, like PD-1/PD-L1 inhibitors, enhance the immune system's ability to recognize and destroy cancer cells. Radiation therapy uses high-energy rays to kill cancer cells. MDM2 inhibitors, like BI 907828, work by blocking the MDM2 protein, which normally inhibits the tumor suppressor p53, thereby allowing p53 to induce cancer cell death. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the cancer's specific characteristics and the patient's overall health.

A Review of Recent Advances in the Treatment of Elderly and Poor Performance NSCLC.