Study on Obrixtamig and Pumitamig for Advanced Small Cell Lung Cancer
Sponsor: Boehringer Ingelheim
ClinicalTrials ID:NCT07843940
This clinical trial is testing two new medicines, obrixtamig and pumitamig, to see if they can help treat advanced small cell lung cancer. The study aims to find out how well patients tolerate these medicines and if they can help shrink tumors.
Patient Parameters
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Program Overview
This study is for adults with advanced small cell lung cancer. It aims to test how well patients tolerate two new medicines, obrixtamig and pumitamig, and whether these medicines can help shrink tumors. Participants are divided into two groups: one group receives obrixtamig and pumitamig, while the other group receives these medicines along with standard chemotherapy (carboplatin and etoposide). All treatments are given through a vein. Participants can continue receiving the study medicines for up to two years if they are benefiting and can tolerate them. Regular visits to the study site are required, including some overnight stays, to monitor health and tumor size.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older who can legally consent to participate.
- Willing and able to attend scheduled visits and follow study instructions.
- Diagnosed with advanced small cell lung cancer.
- For Cohort 1: Must have had at least one but no more than two previous treatments with platinum-based chemotherapy.
- For Cohort 2: Must not have had any previous systemic therapy for advanced small cell lung cancer.
- Must have at least one measurable tumor outside the brain.
- Must provide a previous tumor sample (except in China).
- Must have adequate organ function.
Exclusion Criteria
- Serious medical conditions that could affect safety or study participation.
- Diagnosed with certain other types of cancer.
- Cancer that has spread to the brain or spinal cord lining.
- Allergies to study drugs or similar medications.
- Severe immune-related side effects from previous treatments.
- Ongoing side effects from previous treatments that haven't improved.
- Previous organ or tissue transplant.
- Lung diseases that affect breathing.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Miami | 33136 | Miami | Florida |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
| START New Jersey | 08816 | East Brunswick | New Jersey |
| New York University Langone Medical Center | 10016 | New York | New York |
| SCRI Oncology Partners | 37203 | Nashville | Tennessee |
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