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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 (also called obrixtamig) 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A - Dose escalation: BI 764532 very low dose + carboplatin + etoposide + atezolizumab | Experimental |
| |
| Part A - Dose escalation: BI 764532 low dose + carboplatin + etoposide + atezolizumab | Experimental |
| |
| Part A - Dose escalation: BI 764532 medium dose + carboplatin + etoposide + atezolizumab | Experimental |
| |
| Part A - Dose escalation: BI 764532 high dose + carboplatin + etoposide + atezolizumab | Experimental |
| |
| Part B - Dose expansion: BI 764532 + carboplatin + etoposide + atezolizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 764532 | Drug | BI 764532 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A - Dose escalation: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period | up to 6 weeks | |
| Part B - Dose expansion: Occurrence of dose limiting toxicities (DLTs) during the on-treatment period | up to 23 months |
| Measure | Description | Time Frame |
|---|---|---|
| Part A - Dose escalation: Occurrence of dose limiting toxicities (DLTs) during the on-treatment period | up to 23 months | |
| Part A - Dose escalation: Occurrence of adverse events (AEs) during the on-treatment period | up to 23 months |
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Inclusion Criteria:
Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF)
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 extensive-stage small cell lung carcinoma (ES-SCLC)
Availability of archival tumour tissue
Patients must be eligible for platinum+etoposide+anti-Programmed Cell Death Ligand 1 (PD-L1) regimen as first line standard of care (SoC) treatment:
No prior systemic treatment for ES-SCLC
Prior systematic anti-cancer treatment for limited-stage small cell lung cancer (SCLC) must have been complete at least 6 months prior to the diagnosis of ES-SCLC
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Further inclusion criteria apply.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Health Cancer Institute | Orlando | Florida | 32806 | United States | ||
| Emory University |
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| Label | URL |
|---|---|
| Related Info | View source |
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Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
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|
| Carboplatin | Drug | Carboplatin |
|
| Etoposide | Drug | Etoposide |
|
| Atezolizumab | Drug | Atezolizumab |
|
| Part B - Dose expansion: Objective response (OR) | OR is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 (based on investigator's assessment) from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent | up to 23 months |
| Part B - Dose expansion: Duration of response (DoR) | DoR is defined as the time from first documented confirmed objective response (OR) until the earliest date of disease progression or death among patients with confirmed objective response | up to 23 months |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| INS Bergonie | Bordeaux | 33000 | France |
| Hôpital Louis Pradel | Bron | 69677 | France |
| HOP Civil | Strasbourg | 67091 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Universitätsklinikum Gießen und Marburg GmbH | Giessen | 35392 | Germany |
| Saitama Medical University International Medical Center | Saitama, Hidaka | 350-1298 | Japan |
| Hamamatsu University Hospital | Shizuoka, Hamamatsu | 431-3192 | Japan |
| National Cancer Center Hospital | Tokyo, Chuo-ku | 104-0045 | Japan |
| Japanese Foundation for Cancer Research | Tokyo, Koto-ku | 135-8550 | Japan |
| Medical University Gdansk | Gdansk | 80-214 | Poland |
| Polish Mother's Memorial Hospital - Research Institute | Lodz | 93-338 | Poland |
| MED POLONIA SP Z O O, Clinical Trials Department,Poznan | Poznan | 60-693 | Poland |
| Hospital Universitario Ramon Y Cajal | Madrid | 28034 | Spain |
| Fundación Jiménez Díaz | Madrid | 28040 | Spain |
| Hospital Universitario Virgen De La Macarena | Seville | 41009 | Spain |
| Instituto Valenciano de Oncología | Valencia | 46009 | Spain |
| University Hospital of Lausanne | Lausanne | 1011 | Switzerland |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D005047 | Etoposide |
| C000594389 | atezolizumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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