Study on Targeted Therapy with CDK4/6 Inhibitors for Lung Cancer That Hasn't Responded to Chemotherapy
Sponsor: Case Comprehensive Cancer Center
ClinicalTrials ID:NCT04010357
This clinical trial is testing a new medicine called Abemaciclib to see if it can help shrink lung cancer tumors that haven't responded to chemotherapy or have returned after treatment. The study focuses on small cell lung cancer and other similar types of lung cancer.
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Program Overview
The purpose of this study is to test how well the medicine Abemaciclib, a CDK4/6 inhibitor, works to shrink lung cancer tumors and to check its safety in patients with certain types of lung cancer. This includes small cell lung cancer (SCLC), large cell neuroendocrine lung cancer, and other high-grade neuroendocrine cancers of the lung that have not responded to treatment or have come back after chemotherapy.
Description
This study is being conducted at multiple centers and involves patients with specific types of lung cancer that have not responded to chemotherapy or have relapsed. The study will test the effectiveness and safety of Abemaciclib, a drug that targets cancer cells by stopping their rapid growth. Cancer cells often grow uncontrollably because they bypass the normal controls that regulate cell division. Abemaciclib works by turning off certain enzymes, CDK4 and CDK6, that are overactive in these cancer cells, thereby stopping their growth.
The study aims to determine:
- How well the tumors respond to the treatment after the first cycle and then every 8 weeks.
- How long patients live without the cancer getting worse and their overall survival.
- The safety of the treatment and any side effects.
- How long the response to the treatment lasts in patients who respond.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of extensive stage small cell lung cancer, large cell neuroendocrine lung cancer, or other high-grade neuroendocrine lung cancer.
- Must have a specific type of cancer cell marker called Retinoblastoma wild type.
- Cancer must not have responded to 1-2 cycles of chemotherapy or must have relapsed after initial response to chemotherapy.
- Must have measurable cancer according to specific medical criteria.
- Must provide a previous tumor sample if available.
- Must be in good overall health with a performance status score of 2 or less.
- Must have recovered from any side effects of previous chemotherapy or radiotherapy.
- Must be able to swallow pills.
- Must have adequate blood cell counts and organ function.
- Women and men must agree to use effective birth control during the study and for 6 months after treatment.
- Must understand and agree to sign a consent form.
Exclusion Criteria
- Unresolved side effects from previous treatments, except for hair loss or mild nerve damage.
- Currently taking other experimental drugs.
- Serious preexisting medical conditions that would prevent participation, such as severe lung disease or certain digestive disorders.
- Pregnant or breastfeeding women.
- History of allergic reactions to similar drugs.
- Uncontrolled illnesses, such as heart problems or psychiatric conditions that would affect study participation.
- Active infections requiring treatment, such as HIV or hepatitis B or C.
- HIV-positive patients on certain medications due to potential drug interactions and increased risk of infections.
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