This study is open to adults with extensive-stage small cell lung cancer. The purpose of this study is to find out how well people with this type of cancer tolerate taking study medicines called obrixtamig and pumitamig. Another purpose is to check whether the combination study treatment can make tumours shrink. Obrixtamig and pumitamig are being developed to help the immune system fight cancer.
Participants are put into 2 groups. One group gets obrixtamig and pumitamig. The other group gets obrixtamig and pumitamig with standard chemotherapy (carboplatin and etoposide). All study treatments are given as infusions into a vein.
This study does not have a fixed duration. Participants can receive obrixtamig and pumitamig for up to 2 years if they benefit from treatment and can tolerate it. Participants visit the study site regularly, with some overnight stays required. During this time, doctors regularly check for health problems that could be caused by the study treatment. They also monitor the size of the tumour(s) and take laboratory tests.
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses.
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).
Willing and able to comply with scheduled visits, treatment schedule, the planned trial assessments, laboratory tests, restrictions regarding prohibited medications, lifestyle restrictions, and other requirements related to the trial. This includes that they are able to understand and follow trial-related instructions.
Histologically or cytologically confirmed Extensive Stage Small Cell Lung Carcinoma (ES-SCLC) [using the AJCC (American Joint Committee on Cancer) tumour node metastasis staging system combined with Veterans Administration Lung Study Group (VALG)'s two stage classification scheme].
Serious concomitant disease or medical condition such as neurologic, psychiatric (including substance use disorder), active ulcers (gastrointestinal tract or skin) or laboratory abnormalities that may negatively impact patient safety during trial participation, affect compliance with trial requirements or invalidate assessments relevant for the investigation of the safety and preliminary efficacy of the investigational drugs.
Histologically or cytologically confirmed SCLC with combined histology, diagnosis of Merkel cell carcinoma, medullary thyroid carcinoma or neuroendocrine prostate cancer.
Presence of leptomeningeal disease and/or carcinomatous meningitis.
Known hypersensitivity to the trial drugs or their excipients, prior severe, life-threatening hypersensitivity reaction(s) to monoclonal antibodies, or significant risk of allergic or anaphylactic reaction(s) to any of the investigated drug products according to the investigator's judgement.
Parallel
Obrixtamig
DrugObrixtamig
Pumitamig
DrugPumitamig
Carboplatin
DrugCarboplatin
Etoposide
DrugEtoposide
Occurrence of treatment-emergent adverse events (AEs) leading to trial medication discontinuation or dose modification
Occurrence of dose-limiting toxicities (DLTs) during the DLT evaluation period
Occurrence of treatment-emergent DLTs
Occurrence of treatment-emergent adverse events of special interest (AESIs)
Occurrence of treatment-emergent adverse events (AEs) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥3
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Boehringer Ingelheim
Lead sponsor
BioNTech SE
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
