BI 764532 + Standard Care for Small Cell Lung Cancer

(DAREONᵀᴹ-8 Trial)

Recruiting at 21 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Boehringer Ingelheim

Must be taking: Chemotherapy, Immunotherapy

Must not be taking: Investigational drugs

Disqualifiers: Leptomeningeal carcinomatosis, Recent major surgery, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: up to 23 months

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have had any systemic anti-cancer therapy or investigational drug within 28 days before starting the trial treatment.

How does the drug BI 764532 differ from other treatments for small cell lung cancer?

BI 764532 is a novel treatment being studied in combination with standard care for small cell lung cancer, which typically involves chemotherapy with drugs like cisplatin or carboplatin and etoposide. This new drug may offer a different mechanism of action or improved outcomes compared to the traditional chemotherapy regimens that have been the standard for many years. ^{1 2 3 4 5}

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 are eligible for standard of care including chemotherapy and anti-PD-L1 (Programmed Cell Death Ligand 1) immunotherapy. The purpose of this study is to find out the highest dose of BI 764532 that people can tolerate when taken together with standard of care. BI 764532 is an antibody-like molecule that may help the immune system fight cancer. Participants get BI 764532 and different standard treatments as infusions into a vein. If there is benefit for the participants and if they can tolerate it, the treatment is given for the entire duration of the study. 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 can receive standard chemotherapy and anti-PD-L1 immunotherapy. They must be over 18, able to consent, have a performance status of 0-1 (which means they are fully active or restricted in physically strenuous activity but ambulatory), and have not had prior treatment for extensive-stage SCLC.

Inclusion Criteria

I have signed the consent form for this trial.

I am eligible for treatment with carboplatin, etoposide, and atezolizumab.

I am eligible for treatment with etoposide, carboplatin or cisplatin, and atezolizumab or durvalumab.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BI 764532 combined with standard of care treatments (chemotherapy and anti-PD-L1 immunotherapy) as intravenous infusions. The treatment is given for the entire duration of the study if tolerated.

up to 23 months

Regular visits depending on treatment response

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• BI 764532

Trial Overview The trial is testing the highest tolerable dose of BI 764532, an antibody-like molecule that might boost the immune system's ability to fight cancer. It's given with standard treatments as infusions into a vein. The study measures how well patients tolerate this combination therapy.

Participant Groups

Group I: Part B - Dose expansion: BI 764532 + cisplatin + etoposide + durvalumab Experimental Treatment 4 Interventions

Group II: Part B - Dose expansion: BI 764532 + carboplatin + etoposide + durvalumab Experimental Treatment 4 Interventions

Group III: Part B - Dose expansion: BI 764532 + carboplatin + etoposide + atezolizumab Experimental Treatment 4 Interventions

Group IV: Part A - Dose escalation: BI 764532 very low dose + carboplatin + etoposide + atezolizumab Experimental Treatment 4 Interventions

Group V: Part A - Dose escalation: BI 764532 medium dose + carboplatin + etoposide + atezolizumab Experimental Treatment 4 Interventions

Group VI: Part A - Dose escalation: BI 764532 low dose + carboplatin + etoposide + atezolizumab Experimental Treatment 4 Interventions

Group VII: Part A - Dose escalation: BI 764532 high dose + carboplatin + etoposide + atezolizumab Experimental Treatment 4 Interventions

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Findings from Research

Small cell lung cancer (SCLC) is highly sensitive to chemotherapy and radiation, with the standard treatment being a combination of platinum and etoposide, which is more effective when combined with thoracic radiotherapy (TRT), increasing survival by about 5%.

Prophylactic cranial radiation can prevent central nervous system recurrence and improve survival, while other novel agents like bevacizumab are showing promise and are under further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Small cell lung cancer. Sher, T., Dy, GK., Adjei, AA.[2022]

Recent phase III trials have shown that adding immunotherapy (specifically anti-PD-L1 antibodies like atezolizumab and durvalumab) to standard platinum-doublet chemotherapy significantly improves overall survival for patients with extensive-stage small cell lung cancer (SCLC).

This marks the first significant advancement in survival outcomes for SCLC in over 30 years, establishing new standards of care that offer hope for better treatment results in this aggressive cancer type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dashing Decades of Defeat: Long Anticipated Advances in the First-line Treatment of Extensive-Stage Small Cell Lung Cancer. Armstrong, SA., Liu, SV.[2021]

In a study of 4408 patients with small cell lung cancer (SCLC), cisplatin did not show a survival advantage over carboplatin for either extensive-stage (ES-SCLC) or limited-stage (LS-SCLC) disease, indicating that both treatments are similarly effective.

Carboplatin's favorable toxicity profile makes it a suitable option for both LS-SCLC and ES-SCLC, potentially allowing for better integration with new treatment strategies in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Carboplatin With Cisplatin in Small Cell Lung Cancer in US Veterans. Azar, I., Yazdanpanah, O., Jang, H., et al.[2023]

For limited small-cell lung cancer (SCLC), the best treatment is a combination of platinum-based chemotherapy and early concurrent thoracic radiotherapy using a hyperfractionated regimen.

In Japan, the standard treatment for extensive SCLC involves a combination of irinotecan and cisplatin, with ongoing hopes for new molecular-targeted therapies to improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of small cell lung cancer]. Negoro, S.[2018]

The ECI regimen, which combines irinotecan, cisplatin, and etoposide over three days, demonstrated a high response rate of 77% in advanced-stage small-cell lung cancer patients, indicating its efficacy as a treatment option.

The maximum tolerated dose of irinotecan was established at 140 mg/m², with manageable side effects including febrile neutropenia and grade 3 diarrhea, suggesting that the regimen is well tolerated by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I study of etoposide, cisplatin and irinotecan triplet in patients with advanced-stage small-cell lung cancer. Briasoulis, E., Samantas, E., Kalofonos, H., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Small cell lung cancer. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Dashing Decades of Defeat: Long Anticipated Advances in the First-line Treatment of Extensive-Stage Small Cell Lung Cancer. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Comparison of Carboplatin With Cisplatin in Small Cell Lung Cancer in US Veterans. [2023]

4. Japan pubmed.ncbi.nlm.nih.gov

[Treatment of small cell lung cancer]. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Phase I study of etoposide, cisplatin and irinotecan triplet in patients with advanced-stage small-cell lung cancer. [2018]