CC-486 + Pembrolizumab for Lung Cancer
Trial Summary
What is the purpose of this trial?
The purpose of this study is to determine whether the combination therapy of CC-486 (oral azacitidine) and pembrolizumab provides improved patient outcomes compared to pembrolizumab alone in patients with previously treated locally advanced or metastatic non-small cell lung cancer.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on certain treatments like monoclonal antibodies or have had recent radiation therapy, you may need to wait a specific period before starting the trial. It's best to discuss your current medications with the trial team to get a clear answer.
What data supports the effectiveness of the drug pembrolizumab for lung cancer?
Pembrolizumab has been shown to improve survival in patients with advanced non-small cell lung cancer, especially when the cancer cells have high levels of a protein called PD-L1. It is approved for use in certain lung cancer patients and has demonstrated better outcomes compared to traditional chemotherapy.12345
Is the combination of CC-486 and Pembrolizumab safe for humans?
Pembrolizumab (also known as Keytruda) has been used in various cancer treatments and is generally considered safe, but it can cause side effects like fatigue, cough, and nausea. Serious side effects, such as pneumonitis (lung inflammation), have been reported in 1%-5% of patients. Always discuss potential risks with your healthcare provider.13467
How is the drug CC-486 + Pembrolizumab unique for treating lung cancer?
The combination of CC-486 and Pembrolizumab is unique because Pembrolizumab is a PD-1 inhibitor that helps the immune system attack cancer cells, and it has shown effectiveness in treating various cancers, including lung cancer, by improving survival rates compared to traditional chemotherapy. This combination may offer a novel approach by potentially enhancing the immune response against lung cancer.13489
Research Team
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Eligibility Criteria
This trial is for adults with stage IIIB or IV non-small cell lung cancer (NSCLC) who have had only one prior platinum-based chemotherapy. They must not be pregnant, agree to contraception, and have good organ function. Excluded are those with certain medical conditions, previous treatments like azacitidine, or severe allergies to trial drugs.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CC-486 plus pembrolizumab or placebo plus pembrolizumab in 21-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment, with anticancer treatment and survival followed every 8 weeks
Treatment Details
Interventions
- CC-486
- Pembrolizumab
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
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Who Is Running the Clinical Trial?
Celgene
Lead Sponsor
Jay Backstrom
Celgene
Chief Medical Officer since 2016
MD
Mark Alles
Celgene
Chief Executive Officer since 2016
Bachelor's degree from Lock Haven University of Pennsylvania