Veliparib + Chemoradiation for Advanced Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how well the drug veliparib works with standard treatments for advanced non-small cell lung cancer that cannot be surgically removed. The researchers aim to find the best dose of veliparib and determine if it enhances the effectiveness of radiation and chemotherapy (carboplatin and paclitaxel) in stopping cancer cell growth. Participants receive either veliparib with radiation and chemotherapy or a placebo with radiation and chemotherapy. Ideal candidates are those newly diagnosed with stage III non-small cell lung cancer that cannot be surgically removed and who have not received previous lung cancer treatment. As a Phase 1/Phase 2 trial, this research focuses on understanding how veliparib works in people and measuring its effectiveness in an initial group, offering participants a chance to contribute to groundbreaking cancer treatment advancements.
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that patients must not have received any prior systemic therapy for lung cancer and may not be planning to receive any other investigational agents.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found that patients who took veliparib with chemotherapy experienced some side effects. Leukopenia, a condition characterized by a lower number of white blood cells, was more common in these patients, with a risk ratio of 2.12. In simpler terms, patients were about twice as likely to experience this side effect compared to those not taking veliparib.
Researchers continue to study veliparib, and these findings contribute to understanding its safety. It is important to consult a doctor before joining a trial to ensure it aligns with individual health needs.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Veliparib combined with chemoradiation for advanced non-small cell lung cancer because it introduces a novel mechanism of action. Unlike standard treatments that primarily rely on chemotherapy and radiation, Veliparib is a PARP inhibitor, which means it targets cancer cells' ability to repair their DNA, potentially making them more susceptible to damage from chemotherapy and radiation. This combination could enhance the effectiveness of traditional treatments like carboplatin and paclitaxel, potentially leading to better outcomes for patients. Additionally, the inclusion of a placebo-controlled arm in the trial helps to rigorously evaluate the true impact of Veliparib, providing clearer insights into its benefits.
What evidence suggests that this trial's treatments could be effective for advanced non-small cell lung cancer?
Research shows that veliparib, a PARP inhibitor, can enhance chemotherapy's effectiveness. Early tests found it boosts the effects of certain chemotherapy drugs, like carboplatin, which damage cancer cell DNA. Initial results in patients with non-small cell lung cancer suggest that adding veliparib to standard chemotherapy might slow cancer growth, though the evidence is not yet conclusive. This indicates potential, but further research is needed to confirm its effectiveness. In this trial, one group of participants will receive veliparib with radiation and chemotherapy, while another group will receive a placebo with radiation and chemotherapy. The study aims to determine whether combining veliparib with both radiation and chemotherapy is more effective than using only chemotherapy and radiation for treating advanced non-small cell lung cancer.36789
Who Is on the Research Team?
Athanassios (Ethan) Argiris
Principal Investigator
SWOG Cancer Research Network
Are You a Good Fit for This Trial?
This trial is for adults with stage III non-small cell lung cancer that can't be surgically removed. They must have certain lung function, not be pregnant or breastfeeding, able to swallow pills, and have no history of seizures or other cancers (with some exceptions). Participants need normal liver and kidney function tests, a performance status showing they're mostly active and capable, and cannot have had prior treatments for lung cancer.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Therapy
Patients undergo 3-dimensional conformal radiation therapy once daily, 5 days a week, for 6 weeks. They also receive veliparib orally twice daily and carboplatin and paclitaxel intravenously on specified days.
Consolidation Therapy
Patients receive veliparib orally and carboplatin and paclitaxel intravenously. Treatment repeats every 21 days for 2 courses.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs every 4 months for the first 2 years, then every 6 months until 5 years.
What Are the Treatments Tested in This Trial?
Interventions
- 3-Dimensional Conformal Radiation Therapy
- Carboplatin
- Paclitaxel
- Veliparib
3-Dimensional Conformal Radiation Therapy is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:
- Various types of cancer, including gynecologic cancers
- Various types of cancer, including gynecologic cancers
- Various types of cancer, including gynecologic cancers
- Various types of cancer, including gynecologic cancers
- Various types of cancer, including gynecologic cancers
- Various types of cancer, including gynecologic cancers
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor