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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.

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.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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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I had radiotherapy less than 4 weeks ago or only to relieve symptoms.

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I have undergone multiple treatments for my advanced stage cancer.

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I have been treated with drugs targeting the immune system for cancer.

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I have ongoing severe diarrhea or problems absorbing nutrients.

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I have had serious heart problems in the last 6 months.

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I have had lung inflammation or pneumonitis treated with steroids.

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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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

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 more

Side effects data

From 2023 Phase 2 trial • 240 Patients • NCT02250326

57%

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

Pulmonary embolism

Abdominal pain

Musculoskeletal pain

Pleural effusion

Dry skin

Pain in extremity

Neutrophil count decreased

Dyspepsia

Leukopenia

Muscle spasms

Pneumonia

Nasopharyngitis

Oral candidiasis

Anxiety

General physical health deterioration

Haemorrhoids

Back pain

Vision blurred

Haemoptysis

Vertigo

Muscular weakness

Upper respiratory tract infection

Productive cough

Abdominal pain upper

Non-cardiac chest pain

Epistaxis

Musculoskeletal chest pain

Hypophosphataemia

Pruritus

Urinary tract infection

Rhinorrhoea

Pruritus generalised

Hypomagnesaemia

Alanine aminotransferase increased

Performance status decreased

Respiratory tract infection

Bronchitis

Hypotension

Cancer pain

Pneumonitis

Hemiparesis

Lower respiratory tract infection

Hyponatraemia

Paraparesis

Abdominal wall abscess

Blood glucose increased

Generalised tonic-clonic seizure

Intestinal obstruction

Confusional state

Acute kidney injury

Haematuria

Acute respiratory distress syndrome

Interstitial lung disease

Flushing

Circulatory collapse

Influenza

Febrile neutropenia

Metastases to meninges

Flatulence

Urinary tract obstruction

Respiratory distress

Pneumonia pneumococcal

Sudden death

100%

80%

60%

40%

20%

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