Chemotherapy + Bevacizumab for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if adding bevacizumab (also known as Avastin), a drug that may inhibit tumor growth by blocking blood vessels, enhances the effectiveness of chemotherapy for people with non-small cell lung cancer. The trial compares two groups: one receiving chemotherapy alone and the other receiving chemotherapy with bevacizumab. It targets individuals who have undergone surgery to remove their lung cancer and have stage IB, II, or IIIA non-small cell lung cancer. Participants should have fully recovered from surgery and not have certain other health issues, such as recent heart problems or active infections. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you must stop taking certain blood thinners like clopidogrel (Plavix) at least 7 days before joining. If you're on anti-hypertensive therapy, you should be on a stable regimen.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that adding bevacizumab to standard chemotherapy for non-small cell lung cancer (NSCLC) can cause some side effects. Studies have found that patients might experience bleeding, high blood pressure, protein in the urine, and blood clots, which are the main concerns reported in clinical trials.
For chemotherapy drugs like cisplatin, docetaxel, gemcitabine, pemetrexed, and vinorelbine, common side effects often include nausea, tiredness, and a decrease in blood cell counts, potentially leading to infections. These side effects are generally expected with chemotherapy but can vary from person to person.
This trial is in a late phase, indicating that a lot of safety information is already available. The FDA has approved bevacizumab for treating other types of cancer, so its overall safety is well-understood. However, the combination of these treatments is still under study to ensure safety and effectiveness for this specific type of lung cancer.12345Why are researchers excited about this trial's treatments?
Researchers are excited about combining chemotherapy with bevacizumab for treating non-small cell lung cancer because bevacizumab offers a unique approach. Unlike standard chemotherapy, which targets rapidly dividing cancer cells, bevacizumab works by inhibiting the growth of blood vessels that supply the tumor, effectively starving it. This dual-action strategy could potentially enhance the effectiveness of treatment by attacking the cancer from two angles. Additionally, the inclusion of bevacizumab is designed to extend the duration of treatment effectiveness, providing hope for longer-lasting results.
What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?
In this trial, participants will be assigned to one of two treatment arms. Research has shown that using bevacizumab with chemotherapy, as in Arm II, can be more effective than chemotherapy alone, as in Arm I, for treating non-small cell lung cancer (NSCLC). Studies have found that adding bevacizumab to standard chemotherapy helps patients with advanced NSCLC live longer. Bevacizumab stops the growth of new blood vessels that tumors need to grow. Clinical trial data indicate that bevacizumab helps delay cancer progression longer than chemotherapy alone. This combination has been well-studied and is commonly used for treating advanced NSCLC.23678
Who Is on the Research Team?
Heather A Wakelee
Principal Investigator
ECOG-ACRIN Cancer Research Group
Are You a Good Fit for This Trial?
This trial is for adults with stage IB-IIIA non-small cell lung cancer removed by surgery. They must not have had hormonal or radiation therapy within the last 5 years, be recovered from surgery, and have good organ function and blood counts. Pregnant or breastfeeding women can't join, nor can those with recent serious health issues like heart failure or bleeding disorders. Participants need controlled blood pressure and no history of stroke or significant infections.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive adjuvant chemotherapy with or without bevacizumab. Chemotherapy regimens repeat every 21 days for up to 4 courses. Bevacizumab treatment repeats every 21 days for up to 1 year.
Follow-up
Participants are monitored for overall survival and disease-free survival after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- Bevacizumab
- Cisplatin
- Docetaxel
- Gemcitabine Hydrochloride
- Pemetrexed Disodium
- Questionnaire Administration
- Vinorelbine Tartrate
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
SWOG Cancer Research Network
Collaborator
Southwest Oncology Group
Collaborator
Cancer and Leukemia Group B
Collaborator
North Central Cancer Treatment Group
Collaborator
NCIC Clinical Trials Group
Collaborator