Adjuvant Chemotherapy for Non-Small Cell Lung Cancer
Recruiting in Palo Alto (17 mi)
+66 other locations
Overseen byDavid R Spigel, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Razor Genomics
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial uses a test that examines 14 genes to predict if early-stage lung cancer will return or spread after surgery. It targets patients with Stage I or Stage IIA non-small cell lung cancer who are at high risk. The test helps doctors decide if additional treatment like chemotherapy is needed.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for more information.
What data supports the idea that Adjuvant Chemotherapy for Non-Small Cell Lung Cancer is an effective treatment?
The available research shows that adjuvant chemotherapy, which is a treatment given after surgery, can improve survival rates for patients with non-small cell lung cancer. For example, one study found that this treatment increased 5-year survival rates by 4% to 15%. Another analysis showed a 5.4% increase in survival rates when using a specific drug combination. These studies suggest that adjuvant chemotherapy can help patients live longer after their cancer has been surgically removed.
12345What safety data exists for adjuvant chemotherapy in non-small cell lung cancer?
Safety data for adjuvant chemotherapy in non-small cell lung cancer includes information on adverse effects, particularly in early-stage populations and long-term survivors, as well as treatment-related toxicity observed in the general population. Studies have evaluated the safety profile in older patients and the impact of delayed chemotherapy initiation on patient tolerance.
678910Is adjuvant chemotherapy a promising treatment for non-small cell lung cancer?
Yes, adjuvant chemotherapy is a promising treatment for non-small cell lung cancer. It has been shown to improve survival rates for patients who have had surgery to remove the cancer. Studies have found that it can increase the 5-year survival rates by 4% to 15%, making it a standard treatment option for these patients.
14111213Eligibility Criteria
This trial is for adults who've had surgery to remove Stage I or IIA non-squamous NSCLC and are at high risk of the cancer returning. They must be able to undergo chemotherapy, have a life expectancy of over 5 years excluding their lung cancer diagnosis, and be in good physical condition with fully healed surgical incisions.Inclusion Criteria
Excluding my lung cancer, my health suggests I could live 5 more years.
I have provided a tissue sample for a specific genetic test.
I am 18 years old or older.
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Participant Groups
The study is testing if post-operative adjuvant chemotherapy can improve survival compared to just watching patients with radiographic surveillance after surgery. It uses a new tool called the 14-Gene Prognostic Assay to identify those at higher risk of death within five years from lung cancer.
2Treatment groups
Active Control
Group I: ObservationActive Control2 Interventions
Post-operative observation of Stage I or Stage IIA non squamous non-small cell lunger cancer with Radiographic Surveillance is a current standard of care. Patients identified as low risk will be observation. Those patients identified as intermediate or high-risk by the 14-Gene Prognostic Assay will be randomized either to this arm or the Adjuvant Chemotherapy Arm.
Group II: Adjuvant ChemotherapyActive Control2 Interventions
Adjuvant Chemotherapy is a current standard of care for intermediate or high-risk Stage I or Stage IIA non-squamous non-small cell lung cancer. Patients identified as intermediate or high-risk by the 14-Gene Prognostic Assay will be randomized either to this arm or the Observation Arm.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Providence St. John's Health CenterSanta Monica, CA
Baptist Health LexingtonLexington, KY
Sarah Cannon- Messino Cancer CenterAsheville, NC
Sarah Cannon- FCS NorthSaint Petersburg, FL
More Trial Locations
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Who Is Running the Clinical Trial?
Razor GenomicsLead Sponsor
Encore ClinicalCollaborator
References
[Clinical study of post-operative adjuvant chemotherapy in non-small cell lung cancer]. [2010]Post-operative adjuvant chemotherapy in non-small cell lung can- cer (NSCLC) has been a highlight around the world. The aim of this study is to investigate the efficacy of adjuvant chemotherapy on the survival of patients with NSCLC after complete resection.
Phase II trial of adjuvant chemotherapy with bi-weekly carboplatin plus paclitaxel in patients with completely resected non-small cell lung cancer. [2022]Adjuvant chemotherapy improves the prognosis of patients with non-small cell lung cancer (NSCLC) after a complete resection despite unacceptable toxicity and low compliance.
Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE Collaborative Group. [2022]Several recent trials have shown a significant overall survival (OS) benefit from postoperative cisplatin-based chemotherapy in patients with non-small-cell lung cancer (NSCLC). The aim of the Lung Adjuvant Cisplatin Evaluation was to identify treatment options associated with a higher benefit or groups of patients who particularly benefit from postoperative chemotherapy.
Adjuvant chemotherapy in patients with completely resected non-small cell lung cancer. [2022]Adjuvant chemotherapy has been established as a standard for patients with completely resected non-small cell lung cancer (NSCLC). Adjuvant chemotherapy increased the 5-year survival rates by 4% to 15% within randomized trials and, based on a meta-analysis of five cisplatin-based trials, by 5.4%. Adjuvant chemotherapy consists of a cisplatin-based doublet, preferentially cisplatin plus vinorelbine. Future improvements in outcome of adjuvant therapy are expected by customized chemotherapy and the integration of targeted therapies or immunotherapy.
Adjuvant chemotherapy after pulmonary resection for lung cancer. [2018]Adjuvant chemotherapy using a cisplatin-based regimen is currently recommended for patients with stage II and III non-small cell lung cancer (NSCLC) after complete tumor resection and may be considered for patients with stage IB NSCLC. Although adjuvant chemotherapy after complete resection of localized NSCLC is associated with an absolute survival advantage of approximately 5% at 5 years, there is still a relatively high risk of relapse even for early-stage NSCLC. Efforts are ongoing to identify new treatments in the adjuvant setting and to select patients for individualized treatment based on biomarkers.
Comprehensive Assessment of the Clinical Risk Factors of Postoperative Adverse Events and Survival in Patients With Non-small-cell Lung Cancer. [2023]Postoperative adverse events are associated with poor clinical outcomes and survival in patients with non-small-cell lung cancer (NSCLC) treated with curative operation. However, comprehensive evaluation of the clinical characteristics associated with postoperative adverse events and survival outcomes is lacking.
Major clinical benefit from adjuvant chemotherapy for stage II-III non-small cell lung cancer patients aged 75 years or older: a propensity score-matched analysis. [2022]Data are currently insufficient to support the use of adjuvant chemotherapy (ACT) after surgical resection for stage II or III non-small cell lung cancer (NSCLC) in patients aged ≥ 75 years. In this study we evaluated efficacy and safety profile of ACT in this population.
Adjuvant chemotherapy for non-small cell lung cancer: practice patterns and outcomes in the general population of Ontario, Canada. [2018]Adjuvant chemotherapy (ACT) is known to improve survival in patients with early-stage non-small cell lung cancer. Herein, we describe chemotherapy regimens used, dose modifications, survival, and treatment-related toxicity in the general population.
Association of Delayed Adjuvant Chemotherapy With Survival After Lung Cancer Surgery. [2023]Adjuvant chemotherapy offers a survival benefit to a number of staging scenarios in non-small-cell lung cancer. Variable recovery from lung cancer surgery may delay a patient's ability to tolerate adjuvant chemotherapy, yet the urgency of chemotherapy initiation is unclear.
Substantial risk affects the stage-dependent outcomes of cisplatin-based adjuvant chemotherapy for completely resected non-small cell lung cancer. [2021]Effective adjuvant chemotherapy (Adj.C) for completely resected non-small cell lung cancer (NSCLC) was recently established. However, there may be some unresolved adverse effects, as have been observed in early stage populations or long-term survivors after other types of Adj.C. The substantial risk in such patients was examined by a mathematical method.
Role of adjuvant chemotherapy in the treatment of non-small-cell lung cancer. [2019]The role of adjuvant chemotherapy in the treatment of non-small-cell lung cancer (NSCLC) is described.
Adjuvant therapy of operable nonsmall cell lung cancer: an update. [2021]The current status of postoperative adjuvant therapy for nonsmall cell lung cancer (NSCLC) is reviewed.
Randomized phase 2 trial on refinement of early-stage NSCLC adjuvant chemotherapy with cisplatin and pemetrexed versus cisplatin and vinorelbine: the TREAT study. [2020]Adjuvant chemotherapy is beneficial in non-small-cell lung cancer (NSCLC). However, balancing toxicity and efficacy mandates improvement.