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PD-1 Inhibitor
CC-486 + Pembrolizumab for Lung Cancer
Loewenstein, Germany
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.
Must not have
Participant has a known history or current diagnosis of HIV infection.
Participants with non-squamous histology has known or unknown sensitizing EGFR and/or ALK mutation.
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
Summary
This trial will test whether adding CC-486 to pembrolizumab improves outcomes for patients with NSCLC that has progressed after prior treatment.
See full description
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.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with HIV.
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My non-squamous lung cancer may have EGFR or ALK mutations.
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I've had lung radiation therapy of more than 30 Gy in the last 6 months.
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I have been treated with drugs like azacitidine or decitabine before.
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Select...
I had radiotherapy less than 4 weeks ago or only to relieve symptoms.
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Select...
I have undergone multiple treatments for my advanced stage cancer.
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Select...
I have been treated with drugs targeting the immune system for cancer.
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Select...
I have ongoing severe diarrhea or problems absorbing nutrients.
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Select...
I have had serious heart problems in the last 6 months.
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Select...
I have had lung inflammation or pneumonitis treated with steroids.
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Select...
I have an autoimmune disease treated with medication in the last 2 years.
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I have a history of serious gut issues like IBD, celiac, or surgeries like gastrectomy.
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I have trouble swallowing pills.
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I do not have uncontrolled brain metastases or carcinomatous meningitis.
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I have active Hepatitis B, Hepatitis C, or tuberculosis.
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I am currently being treated for an infection.
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I have received a transplant from another person.
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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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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%
Paraesthesia
13%
Pyrexia
11%
Weight decreased
11%
Headache
11%
Myalgia
11%
Insomnia
10%
Stomatitis
10%
Dizziness
9%
Abdominal pain
9%
Musculoskeletal pain
9%
Pulmonary embolism
8%
Pleural effusion
8%
Dry skin
8%
Pain in extremity
6%
Leukopenia
6%
Dyspepsia
6%
Nasopharyngitis
6%
Neutrophil count decreased
6%
Muscle spasms
6%
Pneumonia
6%
Oral candidiasis
6%
Anxiety
5%
Vertigo
5%
Vision blurred
5%
Haemorrhoids
5%
General physical health deterioration
5%
Back pain
5%
Haemoptysis
5%
Muscular weakness
4%
Productive cough
4%
Abdominal pain upper
4%
Non-cardiac chest pain
4%
Upper respiratory tract infection
4%
Musculoskeletal chest pain
4%
Epistaxis
4%
Hypophosphataemia
3%
Bronchitis
3%
Hypotension
3%
Urinary tract infection
3%
Alanine aminotransferase increased
3%
Hypomagnesaemia
3%
Performance status decreased
3%
Respiratory tract infection
3%
Rhinorrhoea
3%
Pruritus
3%
Pruritus generalised
3%
Cancer pain
1%
Hyponatraemia
1%
Influenza
1%
Lower respiratory tract infection
1%
Flatulence
1%
Febrile neutropenia
1%
Pneumonitis
1%
Intestinal obstruction
1%
Sudden death
1%
Abdominal wall abscess
1%
Pneumonia pneumococcal
1%
Blood glucose increased
1%
Metastases to meninges
1%
Generalised tonic-clonic seizure
1%
Hemiparesis
1%
Paraparesis
1%
Confusional state
1%
Acute kidney injury
1%
Haematuria
1%
Urinary tract obstruction
1%
Acute respiratory distress syndrome
1%
Interstitial lung disease
1%
Respiratory distress
1%
Circulatory collapse
1%
Flushing
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nab-Paclitaxel + CC-486
Nab-Paclitaxel + Durvalumab
Nab-Paclitaxel
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
Placebo
1995
Completed Phase 3
~2670
CC-486
2015
Completed Phase 2
~670
Pembrolizumab
2017
Completed Phase 3
~2630
Find a Location
Closest Location:Georgetown University Medical Center· Washington, United States· 328 miles
Who is running the clinical trial?
CelgeneLead Sponsor
648 Previous Clinical Trials
129,683 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,599 Previous Clinical Trials
3,391,009 Total Patients Enrolled
Abderrahim (Rahim) Fandi, MD, PhDStudy DirectorCelgene
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.