100 Participants Needed

CC-486 + Pembrolizumab for Lung Cancer

Recruiting at 56 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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

BS

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

You have visible signs of disease in medical imaging tests according to specific guidelines.
I can carry out all my usual activities without help.
I have stage IIIB or IV lung cancer and had one platinum-based treatment.
See 8 more

Exclusion Criteria

I have been diagnosed with HIV.
My non-squamous lung cancer may have EGFR or ALK mutations.
You are allergic to azacitidine or mannitol, or any other ingredients used to make CC-486.
See 25 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CC-486 plus pembrolizumab or placebo plus pembrolizumab in 21-day cycles

60-61 weeks
Every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, with anticancer treatment and survival followed every 8 weeks

Until death, withdrawal of consent, or lost-to follow-up
Every 8 weeks

Treatment Details

Interventions

  • CC-486
  • Pembrolizumab
Trial OverviewThe study tests if combining CC-486 (oral azacitidine) with pembrolizumab improves outcomes in NSCLC compared to pembrolizumab alone. Participants previously treated for advanced NSCLC will either receive the combination therapy or just pembrolizumab.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Pembrolizumab plus PlaceboExperimental Treatment2 Interventions
In this control arm, participants will receive pembrolizumab as a 30 minute IV infusion on day 1 of each 21-day cycle and placebo will be administered by mouth daily on days 1 to 14 of each 21 day cycle. Placebo will also be administered in order to allow blinding of the study.
Group II: CC-486 plus PembrolizumabExperimental Treatment2 Interventions
In the experimental arm, participants will receive a combination of two investigational drugs, CC-486 and pembrolizumab every 21-days.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸
Approved in United States as KEYTRUDA for:
  • 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
🇪🇺
Approved in European Union as KEYTRUDA for:
  • 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
🇬🇧
Approved in United Kingdom as KEYTRUDA for:
  • Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

Find a Clinic Near You

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials
649
Recruited
130,000+
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Jay Backstrom profile image

Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles profile image

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Findings from Research

Pembrolizumab (Keytruda) was approved by the FDA for treating metastatic non-small cell lung cancer (mNSCLC) in patients with tumors expressing PD-L1, showing significant improvements in overall survival (OS) and progression-free survival (PFS) in two major clinical trials with thousands of participants.
In the KEYNOTE-024 trial, pembrolizumab demonstrated a 40% reduction in the risk of death compared to chemotherapy, while in the KEYNOTE-010 trial, it also showed a significant survival advantage over chemotherapy in patients who had previously progressed on treatment.
FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond.Pai-Scherf, L., Blumenthal, GM., Li, H., et al.[2022]
The KEYNOTE-001 trial demonstrated that pembrolizumab significantly improves clinical outcomes for patients with advanced non-small cell lung cancer, indicating its efficacy as a treatment option.
Patients whose tumors express PD-L1 in at least 50% of cells showed better responses to pembrolizumab, suggesting that PD-L1 expression is a key factor in predicting treatment effectiveness.
Pembrolizumab Shows Promise for NSCLC.[2015]
In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.
The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience.Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]

References

FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond. [2022]
Pembrolizumab Shows Promise for NSCLC. [2015]
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
Use of archival versus newly collected tumor samples for assessing PD-L1 expression and overall survival: an updated analysis of KEYNOTE-010 trial. [2023]
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]
Perioperative outcomes of pulmonary resection after neoadjuvant pembrolizumab in patients with non-small cell lung cancer. [2022]
Pembrolizumab monotherapy for non-small cell lung cancer (NSCLC): can patient stratification be improved in the UK Tayside population? A retrospective cohort study. [2023]