Study on Biomarkers to Predict Immunotherapy Response and Second-line Treatment in Advanced Non-small Cell Lung Cancer
Sponsor: City of Hope Medical Center
ClinicalTrials ID:NCT07288034
This clinical trial is exploring how certain biomarkers can help predict how well patients with advanced non-small cell lung cancer (NSCLC) respond to initial immunotherapy and guide the choice of second-line treatments.
Patient Parameters
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Program Overview
This study aims to understand how biomarkers can predict the effectiveness of first-line immunotherapy in patients with advanced non-small cell lung cancer (NSCLC). It also explores how these biomarkers can help select the best second-line treatments for patients whose cancer progresses. The trial involves analyzing blood and tissue samples to learn more about how immunotherapy affects cancer cells and to develop personalized treatment strategies. The study also tests the safety and effectiveness of second-line treatments, including tremelimumab, durvalumab, adagrasib, and bevacizumab, in patients with specific genetic mutations.
Description
The main goals of this study are to develop biomarkers that can predict when first-line immunotherapy might not work and to evaluate different treatment strategies for patients who do not experience early treatment failure. The study also aims to assess the effectiveness of second-line treatments based on specific biomarkers.
In the first part of the study, patients receive a PD(L)1-based therapy, with or without chemotherapy, for up to 24 months. Patients who respond well to this treatment are divided into different groups to either continue or stop the therapy, based on their biomarker results.
In the second part, patients whose cancer progresses are assigned to different treatment groups based on their genetic mutations. These treatments include tremelimumab and durvalumab or adagrasib and bevacizumab. The study will monitor patients' responses and any side effects.
Throughout the study, patients will have regular blood tests and imaging scans to track their progress. The study aims to improve understanding of how biomarkers can guide treatment decisions and improve outcomes for patients with advanced NSCLC.
Eligibility Criteria
Inclusion Criteria
- Must provide informed consent to participate.
- Must have recent molecular testing results or available biopsy tissue.
- Agree to blood collection for research purposes.
- Must be 18 years or older.
- Have a performance status score of 0 to 2, indicating good overall health.
- Have stage IIIB or IV non-small cell lung cancer without certain genetic mutations.
- Scheduled to start or have recently started PD1/PDL1-based therapy.
- Have measurable disease according to standard criteria.
- Meet specific blood count and organ function requirements.
- Women of childbearing potential must have a negative pregnancy test and agree to use birth control during the study.
Exclusion Criteria
- Recent major surgery, except minor procedures.
- Need for high-dose steroids or other immunosuppressive medications.
- Recent radiation therapy.
- Significant heart disease or recent heart attack.
- Active autoimmune disease requiring treatment.
- Active brain metastases or certain lung diseases.
- Active infection requiring antibiotics.
- Other active cancers.
- Pregnant or breastfeeding women.
- Any condition that may pose a safety risk during the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| CTCA at Western Regional Medical Center | 85338 | Goodyear | Arizona |
| City of Hope Corona | 92882 | Corona | California |
| City of Hope Medical Center | 91010 | Duarte | California |
| City of Hope Seacliff | 92648 | Huntington Beach | California |
| City of Hope at Irvine Lennar | 92618 | Irvine | California |
| City of Hope Antelope Valley | 93534 | Lancaster | California |
| City of Hope at Long Beach Elm | 90813 | Long Beach | California |
| City of Hope at Newport Beach Fashion Island | 92660 | Newport Beach | California |
| City of Hope South Pasadena | 91030 | South Pasadena | California |
| City of Hope South Bay | 90503 | Torrance | California |
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