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PD-1 Inhibitor
CC-486 + Pembrolizumab for Lung Cancer
Phase 2
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant has an ECOG performance status of 0 to 1.
Participant is ≥ 18 years of age at the time of signing the informed consent form.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 of study drug treatment to the date of disease progression; up to the clinical cut-off date of 12 april 2017; overall maximum treatment duration was 61 weeks for the cc-486 + pbz arm and 60 weeks for the pbz + placebo arm
Awards & highlights
Study Summary
This trial will test whether adding CC-486 to pembrolizumab improves outcomes for patients with NSCLC that has progressed after prior treatment.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation of organs, infusion-related reactions, fatigue, digestive issues and increased risk of infections due to the immunotherapy nature of pembrolizumab and possible similar effects from CC-486.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can carry out all my usual activities without help.
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I am 18 years old or older.
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My lung cancer is confirmed to be non-small cell type.
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I have stage IIIB or IV lung cancer and had one platinum-based treatment.
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I am a male and will either not have sex or use a condom with women who can get pregnant.
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My liver, kidneys, and bone marrow are functioning well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from day 1 of study drug treatment to the date of disease progression; up to the clinical cut-off date of 12 april 2017; overall maximum treatment duration was 61 weeks for the cc-486 + pbz arm and 60 weeks for the pbz + placebo arm
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 of study drug treatment to the date of disease progression; up to the clinical cut-off date of 12 april 2017; overall maximum treatment duration was 61 weeks for the cc-486 + pbz arm and 60 weeks for the pbz + placebo arm
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Kaplan Meier Estimate of Progression-Free Survival (PFS) Based on European Medicines Agency Methodology
Kaplan Meier Estimate of Progression-Free Survival (PFS) Based on Food and Drug Administration (FDA) Methodology
Secondary outcome measures
Apparent Total Plasma Clearance (CL/F) of CC-486
Apparent Volume of Distribution (Vd/F) of CC-486
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of CC-486
+8 moreSide effects data
From 2023 Phase 2 trial • 240 Patients • NCT0225032657%
Nausea
53%
Vomiting
42%
Diarrhoea
41%
Constipation
34%
Decreased appetite
33%
Asthenia
32%
Alopecia
30%
Fatigue
24%
Peripheral sensory neuropathy
20%
Cough
20%
Dyspnoea
19%
Neutropenia
15%
Anaemia
15%
Oedema peripheral
14%
Arthralgia
13%
Pyrexia
13%
Paraesthesia
11%
Headache
11%
Weight decreased
11%
Myalgia
11%
Insomnia
10%
Stomatitis
10%
Dizziness
9%
Pulmonary embolism
9%
Abdominal pain
9%
Musculoskeletal pain
8%
Pleural effusion
8%
Dry skin
8%
Pain in extremity
6%
Muscle spasms
6%
Neutrophil count decreased
6%
Leukopenia
6%
Dyspepsia
6%
Pneumonia
6%
Nasopharyngitis
6%
Oral candidiasis
6%
Anxiety
5%
Haemorrhoids
5%
Back pain
5%
General physical health deterioration
5%
Vision blurred
5%
Haemoptysis
5%
Vertigo
5%
Muscular weakness
4%
Upper respiratory tract infection
4%
Productive cough
4%
Abdominal pain upper
4%
Non-cardiac chest pain
4%
Epistaxis
4%
Musculoskeletal chest pain
4%
Hypophosphataemia
3%
Urinary tract infection
3%
Rhinorrhoea
3%
Hypomagnesaemia
3%
Alanine aminotransferase increased
3%
Performance status decreased
3%
Respiratory tract infection
3%
Bronchitis
3%
Hypotension
3%
Cancer pain
1%
Lower respiratory tract infection
1%
Abdominal wall abscess
1%
Hemiparesis
1%
Generalised tonic-clonic seizure
1%
Blood glucose increased
1%
Hyponatraemia
1%
Paraparesis
1%
Intestinal obstruction
1%
Confusional state
1%
Acute kidney injury
1%
Haematuria
1%
Acute respiratory distress syndrome
1%
Interstitial lung disease
1%
Flushing
1%
Circulatory collapse
1%
Influenza
1%
Febrile neutropenia
1%
Metastases to meninges
1%
Flatulence
1%
Urinary tract obstruction
1%
Respiratory distress
1%
Pneumonia pneumococcal
1%
Sudden death
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nab-Paclitaxel + CC-486 Combination Arm
Nab-Paclitaxel + Durvalumab Combination Arm
Nab-Paclitaxel Monotherapy Arm
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Placebo
1995
Completed Phase 3
~2670
CC-486
2015
Completed Phase 2
~630
Find a Location
Who is running the clinical trial?
CelgeneLead Sponsor
636 Previous Clinical Trials
128,871 Total Patients Enrolled
Abderrahim (Rahim) Fandi, MD, PhDStudy DirectorCelgene
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,506 Previous Clinical Trials
3,369,430 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You have visible signs of disease in medical imaging tests according to specific guidelines.I've had lung radiation therapy of more than 30 Gy in the last 6 months.I can carry out all my usual activities without help.I have been treated with drugs like azacitidine or decitabine before.I have not been in a clinical trial for a new treatment or device within the last 4 weeks.I had radiotherapy less than 4 weeks ago or only to relieve symptoms.I have undergone multiple treatments for my advanced stage cancer.I have been treated with drugs targeting the immune system for cancer.I have not had a live-virus vaccine in the last 30 days.I have stage IIIB or IV lung cancer and had one platinum-based treatment.I have given a tissue sample from my tumor for PD-L1 testing.I am not pregnant and will use two forms of birth control or practice abstinence.I am a male and will either not have sex or use a condom with women who can get pregnant.I have ongoing severe diarrhea or problems absorbing nutrients.I have had serious heart problems in the last 6 months.I have had lung inflammation or pneumonitis treated with steroids.I have an autoimmune disease treated with medication in the last 2 years.I haven't had cancer in the last 5 years, except for certain skin, cervix, or uterus cancers.I have a history of serious gut issues like IBD, celiac, or surgeries like gastrectomy.I am still experiencing side effects from previous cancer treatments or surgeries.I have trouble swallowing pills.I am 18 years old or older.My lung cancer is confirmed to be non-small cell type.I do not have uncontrolled brain metastases or carcinomatous meningitis.I have active Hepatitis B, Hepatitis C, or tuberculosis.I am currently being treated for an infection.I have received a transplant from another person.My liver, kidneys, and bone marrow are functioning well.I haven't had a monoclonal antibody treatment in the last 4 weeks or have recovered from its side effects.
Research Study Groups:
This trial has the following groups:- Group 1: CC-486 plus Pembrolizumab
- Group 2: Pembrolizumab plus Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial being conducted in numerous hospitals throughout the state?
"Currently, this trial is occurring at 10 different sites. These locations include Saint Louis, Los Angeles and Washington D.C., with other cities hosting the remaining locations. If you are selected for the study, it would be ideal to choose the site nearest you to limit travel as much as possible."
Answered by AI
What are the objectives of this test?
"The primary outcome of this clinical trial, as measured by the sponsor Celgene, is the Kaplan Meier Estimate of Progression-Free Survival (PFS) Based on Food and Drug Administration (FDA) Methodology. This will be evaluated over a period of 61 weeks for the CC-486 + PBZ arm and 60 weeks for the PBZ + Placebo arm. In addition to the primary outcome, this trial will also be assessing secondary outcomes including Time to Maximum Plasma Concentration (Tmax) of CC-486, Maximum Observed Plasma Concentration (Cmax) of CC-486, and Kaplan Meier"
Answered by AI
Does CC-486 have any harmful side effects for people?
"The Power team has assessed CC-486's safety to be a 2. This is because, although there is some data supporting its safety, there is no evidence yet of its efficacy."
Answered by AI
What are the primary maladies that CC-486 is designed to target?
"CC-486 is a medication that oncologists typically prescribe to patients with relapsed or refractory mediastinal large b-cell lymphoma. Additionally, this drug can also be used as part of treatment for conditions like complete blood count and induction chemotherapy."
Answered by AI
How many people are volunteering to test this new treatment?
"This clinical trial is no longer recruiting patients. It was first posted on 10/9/2015 and the most recent edit was on 9/6/2022. If you are looking for other studies, there are currently 1959 clinical trials actively recruiting patients with carcinoma, non-small-cell lung and 1174 trials for CC-486 actively enrolling participants."
Answered by AI
Could you provide more context on CC-486's medical research history?
"Currently, 155 phase 3 trials and 1174 active clinical trials are studying CC-486. The global scope of these studies is large, with 41658 locations running experiments related to CC-486."
Answered by AI
Is this research actively looking for new participants?
"This study is not seeking patients at the moment. The date when this information was last updated was September 6th, 2022 and the trial was first posted on October 9th, 2015. For those looking for other studies, 1174 trials involving CC-486 and 1959 trials for carcinoma, non-small-cell lung are actively enrolling patients."
Answered by AI
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