Study Comparing Tobemstomig and Pembrolizumab with Chemotherapy for Untreated Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
ClinicalTrials ID:NCT05775289
This clinical trial is testing two different treatment combinations for people with advanced non-small cell lung cancer (NSCLC) who have not received any prior treatment. The study compares the effectiveness and safety of tobemstomig with chemotherapy against pembrolizumab with chemotherapy.
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Program Overview
The aim of this study is to see how well a new drug, tobemstomig, works when combined with chemotherapy in treating advanced non-small cell lung cancer (NSCLC) that cannot be removed by surgery. The study will compare this combination to another treatment using pembrolizumab with chemotherapy. Participants in this study have not received any previous treatment for their advanced lung cancer.
Eligibility Criteria
Inclusion Criteria
- Must be in good general health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have a confirmed diagnosis of advanced non-small cell lung cancer (NSCLC) that cannot be surgically removed.
- Have not received any prior treatment for metastatic NSCLC.
- Must know the PD-L1 status of their tumor.
- Must have tumor samples available for testing.
- Must have measurable cancer that can be tracked.
- Expected to live at least 12 more weeks.
- Must have good blood and organ function.
- Must test negative for HIV, hepatitis B, and hepatitis C.
- Must have a healthy heart.
Exclusion Criteria
- Have NSCLC with specific genetic mutations (EGFR or ALK).
- Have untreated or worsening cancer spread to the brain or spinal cord.
- Have a history of certain brain or spinal cord diseases.
- Have uncontrolled pain or fluid buildup in the body that requires frequent drainage.
- Have high calcium levels in the blood that are not controlled.
- Have a history of autoimmune diseases or immune deficiencies, with some exceptions.
- Have lung diseases like pulmonary fibrosis or pneumonitis.
- Have active or untreated tuberculosis.
- Are currently being treated for hepatitis B or C.
- Have had significant heart problems recently.
- Have had major surgery recently or need major surgery during the study.
- Have had another type of cancer in the last 5 years, with some exceptions.
- Have had a severe infection recently.
- Are currently taking antibiotics or have had a stem cell or organ transplant.
- Have any condition that could interfere with the study or pose a risk.
- Have received a live vaccine recently or need one during the study.
- Have participated in another clinical trial recently.
- Have had certain cancer treatments recently.
- Have allergies to the study drugs or their components.
- Are pregnant or breastfeeding.
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