Phase II Study of Chemotherapy and Immunotherapy for Stage IV Non-Small Cell Lung Cancer
Sponsor: Fox Chase Cancer Center
ClinicalTrials ID:NCT03786692
This clinical trial is testing a combination of chemotherapy and immunotherapy drugs to see if they can improve treatment outcomes for patients with advanced non-small cell lung cancer (NSCLC). The study focuses on patients with specific genetic profiles or those who have never smoked.
Patient Parameters
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Program Overview
This study aims to evaluate the effectiveness of combining chemotherapy drugs (carboplatin and pemetrexed) with immunotherapy drugs (bevacizumab and atezolizumab) in treating stage IV non-small cell lung cancer (NSCLC). The trial is particularly interested in patients who have specific genetic mutations or have never smoked. Researchers hope to determine if this combination can improve survival rates and reduce side effects compared to other treatments.
Eligibility Criteria
Inclusion Criteria
- Must have stage IV non-squamous non-small cell lung cancer confirmed by lab tests.
- Must have specific genetic mutations (EGFR mutation in exon 19 or 21) or be a never smoker without certain genetic changes. Never smokers must have smoked less than 100 cigarettes in their lifetime.
- Must have measurable cancer that can be tracked by scans.
- Patients with EGFR mutations must have tried certain targeted therapies before.
- Must not have had chemotherapy, anti-VEGF therapy, or immunotherapy before, except for specific cases with prior targeted therapies.
- Patients with treated, symptom-free brain metastases are eligible if they meet certain conditions.
- Must be over 18 years old and in good overall health (ECOG status 0 or 1).
- Must have normal organ and blood function as shown by specific tests.
- Must be able to provide a tumor sample for the study.
- Women of childbearing potential must use effective birth control during and after the study.
- Men with partners who can become pregnant must use effective birth control during and after the study.
Exclusion Criteria
- Currently receiving other investigational or cancer treatments.
- Recent severe gastrointestinal bleeding.
- Untreated brain metastases larger than 1 cm.
- Severe liver disease or certain heart conditions.
- Uncontrolled high blood pressure or recent severe vascular issues.
- Recent major surgery or serious wounds.
- History of smoking more than 100 cigarettes unless specific genetic mutations are present.
- Active autoimmune diseases requiring treatment in the past year.
- Recent significant bleeding or blood vessel issues.
- Pregnant or breastfeeding women.
- Known allergies to study drugs or related products.
- Previous organ transplants or certain other cancers unless in remission for at least 2 years.
- Uncontrolled pain or other serious health conditions that could interfere with the study.
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