Study on Adding Cabozantinib to Standard Immune Therapy for Non-Small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04310007
This clinical trial is exploring whether adding the pill chemotherapy drug cabozantinib to the standard immune therapy nivolumab is more effective than standard chemotherapy alone for treating non-small cell lung cancer (NSCLC).
Patient Parameters
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Program Overview
This study is comparing different treatments for non-squamous non-small cell lung cancer (NSCLC). It looks at cabozantinib alone, cabozantinib with nivolumab, and standard chemotherapy. Cabozantinib may help stop tumor growth by blocking certain enzymes. Nivolumab is an immunotherapy that helps the immune system attack cancer. The study aims to see if these treatments can be more effective than standard chemotherapy in controlling cancer growth.
Description
The main goal of this study is to see if cabozantinib alone or combined with nivolumab can help patients with non-squamous NSCLC live longer without their cancer getting worse, compared to standard chemotherapy. The study also looks at overall survival rates and how well the cancer responds to treatment in each group.
Participants are divided into three groups:
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Group A: Takes cabozantinib pills daily. Treatment cycles repeat every 21 days unless the cancer progresses or side effects become too severe.
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Group B: Takes cabozantinib pills daily and receives nivolumab through an IV every 21 days. Treatment continues unless the cancer progresses or side effects become too severe.
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Group C: Receives standard chemotherapy, which may include drugs like docetaxel, gemcitabine, paclitaxel, or nab-paclitaxel, every 21 days. If the cancer progresses, patients may switch to Group Z.
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Group Z: For patients from Group C whose cancer progresses. They receive cabozantinib pills daily and nivolumab through an IV every 21 days.
All participants will have regular heart and CT scans and provide blood samples during the study. After treatment, follow-up visits occur every three months for up to three years.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of non-squamous non-small cell lung cancer (NSCLC).
- Cancer must be at an advanced stage (IVA or IVB) and not treatable with surgery.
- Tumor must not have specific genetic mutations (EGFR or ALK).
- Must have previously received one line of platinum-based chemotherapy and one line of immunotherapy.
- Must have measurable cancer that can be tracked with scans.
- Must have good overall health and organ function.
- Women must not be pregnant or breastfeeding and must agree to use contraception during the study and for six months after.
- Must not have had significant bleeding, lung issues, or other serious health problems recently.
- Must not have had major surgery or certain treatments recently.
- Must not have uncontrolled high blood pressure or heart problems.
- Must not be taking certain medications that could interfere with the study drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Veterans Administration Medical Center - Birmingham | 35233 | Birmingham | Alabama |
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
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