Phase I/II Study of Amivantamab and Tepotinib Combination in MET-altered Non-small Cell Lung Cancer
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT06083857
This clinical trial is testing a combination of two drugs, amivantamab and tepotinib, to see if they can help control non-small cell lung cancer (NSCLC) with specific genetic changes. The study will also look at the safety of this drug combination.
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Program Overview
The purpose of this study is to find out if the combination of amivantamab and tepotinib can effectively manage non-small cell lung cancer (NSCLC) that has certain changes in the MET gene. Researchers will also study how safe this combination is for patients.
Description
This study is divided into two main parts: Phase I and Phase II.
In Phase I, researchers will determine the safest dose of the drug combination by monitoring any side effects in patients with advanced NSCLC that has MET gene changes. The goal is to find a dose that patients can tolerate well.
In Phase II, the study will assess how well the drug combination works in shrinking tumors in patients who have not received previous targeted treatments for MET gene changes. Researchers will also evaluate the overall effectiveness of the treatment in different groups of patients.
The study will explore how patients' genetic profiles might influence their response to the treatment and investigate any resistance mechanisms that may develop. This involves analyzing genetic material from tumors and blood samples before and after treatment.
Participants will need to meet specific health criteria and agree to follow certain lifestyle guidelines during the study. Both men and women must use effective birth control methods during the study and for a period after the last dose of treatment to prevent pregnancy.
Eligibility Criteria
Inclusion Criteria
- Be 18 years or older.
- Have a confirmed diagnosis of non-small cell lung cancer (NSCLC) with specific changes in the MET gene.
- Have advanced cancer that cannot be treated with surgery or radiation.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have measurable disease according to standard criteria.
- If there are brain metastases, they must be treated and stable without the need for steroids.
- Be able to swallow pills.
- Previous chemotherapy or immunotherapy is allowed.
- Have adequate blood cell counts and organ function, including:
- Hemoglobin level of at least 10 g/dL.
- Neutrophil count of at least 1.5 x 10^9/L.
- Platelet count of at least 75 x 10^9/L.
- Liver enzymes and bilirubin levels within specified limits.
- Kidney function within specified limits.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
- Men must agree to use condoms during the study and for a period after the last dose of treatment.
- Agree not to donate eggs or sperm during the study and for a period after the last dose of treatment.
- Be willing to follow all study procedures and attend follow-up appointments.
Exclusion Criteria
- For certain groups, previous targeted therapy for MET gene changes is not allowed.
- Have other genetic mutations with previous targeted therapies.
- Have active hepatitis B or C infections.
- Have HIV with certain conditions, such as low CD4 count or recent opportunistic infections.
- Have active heart disease or recent serious cardiovascular events.
- Have uncontrolled medical conditions, such as poorly managed diabetes or active infections.
- Have unstable eye conditions.
- Have a history of lung diseases like pneumonitis.
- Have unresolved side effects from previous treatments.
- Have other active or recent cancers, with some exceptions for certain cured cancers.
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