Study on Cisplatin-based Chemotherapy and Atezolizumab for Certain Stages of Resected Non-small Cell Lung Cancer (NSCLC) and Monitoring Circulating Tumor DNA
Sponsor: Nasser Hanna
ClinicalTrials ID:NCT04367311
This clinical trial is exploring whether combining cisplatin-based chemotherapy with the immunotherapy drug atezolizumab can help prevent cancer recurrence in patients with certain stages of non-small cell lung cancer (NSCLC) after surgery. The study will also monitor circulating tumor DNA (ctDNA) to assess the risk of cancer returning.
Patient Parameters
| Parameter | Options |
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Program Overview
This study aims to find out if using a combination of cisplatin-based chemotherapy and the immunotherapy drug atezolizumab can help reduce the chances of cancer coming back in patients with specific stages of non-small cell lung cancer (NSCLC) after surgery. Researchers will also track circulating tumor DNA (ctDNA) levels, as its presence after surgery is linked to a higher risk of cancer recurrence. The study focuses on patients with stage I (tumors 4cm or larger), IIA, IIB, and select stage III NSCLC who have detectable ctDNA after surgery.
Eligibility Criteria
Inclusion Criteria
- Must provide written consent and agree to share personal health information.
- Be 18 years or older.
- Have a good performance status score of 0 or 1.
- Have had complete surgical removal of stage I (tumors 4cm or larger), IIA, IIB, or select stage III NSCLC with no cancer left behind.
- Have either squamous or non-squamous NSCLC.
- Surgery must have been completed within 60 days before starting treatment.
- Must have tissue samples available for testing.
- Must have adequate organ function based on lab tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during treatment and for 5 months after.
- Men must agree to use condoms or remain abstinent during treatment and for 5 months after.
- Must be able to understand and follow study procedures.
Exclusion Criteria
- Tumors with small cell or large cell neuroendocrine features are not eligible.
- Tumors with specific genetic mutations (EGFR or ALK) are not eligible.
- No prior chemotherapy, radiation, or immunotherapy for this lung cancer.
- No other active cancers.
- No history of certain diseases like leptomeningeal disease.
- No prior treatment with certain immune therapies.
- No recent live vaccines.
- Not currently in another investigational study.
- No immune deficiencies or chronic steroid use.
- No severe allergies to atezolizumab.
- No active autoimmune diseases.
- No significant lung disease or pneumonitis.
- No uncontrolled fluid buildup in the body.
- No uncontrolled high calcium levels.
- No recent significant heart disease.
- No severe infections recently.
- No history of HIV, active hepatitis B or C, or tuberculosis.
- No prior organ transplants.
- No conditions that could interfere with the study.
- Not pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Banner MD Anderson Cancer Center | 85234 | Gilbert | Arizona |
| Northwestern University Feinberg School of Medicine | 60611 | Chicago | Illinois |
| Indiana University Melvin and Bren Simon Cancer Center | 46202 | Indianapolis | Indiana |
| Summit Health | 07922 | Berkeley Heights | New Jersey |
| Rutgers Cancer Institute of New Jersey | 08903 | New Brunswick | New Jersey |
| New York University Clinical Cancer Center | 10016 | New York | New York |
| Ohio State University Comprehensive Cancer Center | 43210 | Columbus | Ohio |
| Penn State Cancer Institute | 17033 | Hershey | Pennsylvania |
| University of Virginia Health System | 22908 | Charlottesville | Virginia |
| University of Wisconsin | 53705 | Madison | Wisconsin |
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