BI 764532 + Topotecan for Small Cell Lung Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you must not be enrolled in another drug trial or have been in one within the last 30 days, and you need to be off steroids and anti-epileptic drugs for at least 7 days if you have brain metastases.
What data supports the effectiveness of the drug combination BI 764532 and Topotecan for treating small cell lung cancer?
Topotecan has shown effectiveness in treating small cell lung cancer (SCLC), especially in patients with recurrent SCLC, providing symptom relief and manageable side effects. It has been used successfully in combination with other drugs for SCLC, suggesting potential benefits when combined with BI 764532.12345
Is the combination of BI 764532 and Topotecan safe for humans?
Topotecan, also known as Hycamtin, has been studied in various cancer treatments and is generally well-tolerated by most patients. The main side effect is myelosuppression (a decrease in bone marrow activity), particularly neutropenia (low levels of a type of white blood cell), but serious side effects are uncommon and manageable.13567
What makes the drug BI 764532 + Topotecan unique for treating small cell lung cancer?
The combination of BI 764532 and Topotecan is unique because it involves a novel drug, BI 764532, paired with Topotecan, a topoisomerase I inhibitor known for its activity in small cell lung cancer. This combination may offer a new approach by potentially enhancing the effectiveness of Topotecan, which is already used in relapsed cases, and exploring new treatment possibilities for this aggressive cancer.12358
What is the purpose of this trial?
This study is open to adults with extensive stage small cell lung cancer. The study is in people with advanced cancer that had previously received platinum-based chemotherapy and are eligible to receive a single agent chemotherapy treatment.The purpose of this study is to find the highest dose of BI 764532 that people can tolerate when taken together with a single agent chemotherapy. BI 764532 is an antibody-like molecule that may help the immune system fight cancer.Participants may continue to take BI 764532 as long as they benefit from treatment and can tolerate it. During this time, participants visit the study site regularly. The visits also depend on the response to the treatment. At the study visits, the doctors check the health of the participants, take necessary laboratory tests, and note any health problems that could have been caused by the study treatment.
Eligibility Criteria
Adults with advanced small cell lung cancer who've had platinum-based chemo can join this trial. They must be eligible for topotecan, have a performance status showing they're mostly active (ECOG 0-1), and provide consent and a tumor sample. People under 18 or those not fit for topotecan cannot participate.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation and Confirmation
Participants receive varying doses of BI 764532 in combination with a single agent chemotherapy to determine the highest tolerable dose
Treatment Continuation
Participants continue to receive BI 764532 as long as they benefit and can tolerate the treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- BI 764532
- Topotecan
BI 764532 is already approved in United States for the following indications:
- None approved; under investigation for extensive-stage small cell lung cancer (ES-SCLC) and extrapulmonary neuroendocrine carcinoma (epNEC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boehringer Ingelheim
Lead Sponsor