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Lung CancerPhase 1NCT03220477

Pembrolizumab (Immunotherapy Drug) in Combination With Guadecitabine and Mocetinostat (Epigenetic Drugs) for Patients With Advanced Lung Cancer.

A Phase 1 study testing Pembrolizumab, Guadecitabine and Mocetinostat in people with Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to test the safety of a combination of three drugs, pembrolizumab, guadecitabine and mocetinostat. Pembrolizumab is a drug given by vein and all patients will receive the same dose. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Pembrolizumab, Guadecitabine and Mocetinostat
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
3 sitesUnited States
Study dates
4 Aug 2017to Jul 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must be capable, willing, and able to provide written, informed consent
  • Age ≥ 18 years old
  • Histologically-confirmed stage IIIb or IV NSCLC by the enrolling institution
  • Patients must have progressed on treatment with an anti-PD1/PD-L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. PD-1/PD-L1 treatment progression is defined by meeting all of the following criteria:
  • Has received at least 2 doses of an approved anti-PD-1/PD-L1 mAb b. Has demonstrated disease progression after PD-1/PD-L1 as defined by RECIST v1.1 (if treatment received as part of a clinical trial with formal RECIST reads performed) or a combination of clinical AND radiologic evidence of progression, as determined by the treating investigator. The initial evidence of disease progression (PD) should ideally be confirmed by a second assessment no less than 4 weeks from the date of the first documented PD, unless there is rapid clinical progression such that follow up imaging is infeasible.
  • Note: Second imaging for confirmation of PD can be waived in rapidly progressing patients after consultation with the Sponsor/PI. Progressive disease has been documented within 24 weeks from the last dose of anti-PD-1/PD-L1 mAb.
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  • Measurable by RECIST v1.1 (those undergoing pre-treatment resection must have imaging assessment after resection to determine measurability)
  • Previously irradiated sites of tumor may be considered measurable if there is radiographic progression at that site subsequent to the time of completing radiation.
  • Have a safely biopsiable tumor lesion and be willing to undergo a pre-treatment and ontreatment core biopsy
  • Pretreatment tissue should be collected via core biopsy, ideally of a non-target lesion.
  • Patients may not have intervening systemic anti-cancer therapy between the time of pre-treatment biopsy/resection and initiating study treatment.
  • ECOG performance status of 0-1.
  • Adequate hematologic, renal, and/or hepatic function (following criteria must be met within 28 days of C1D1):
  • ANC ≥ 1,500/mm3 (≥ 1. 5 × 10^9/L) b. Hemoglobin ≥ 9.0 g/dL c. Platelet count ≥ 100,000/ul (≥ 100,000 per mm3) d. Serum creatinine ≤ 1.5 x ULN OR, for subjects with creatinine levels >1.5 x ULN, an estimated creatinine clearance of ≥ 40 mL/min calculated using the Cockcroft and Gault formula ((140-Age) • Mass (kg)/(72 • creatinine mg/dL); multiply by 0.85 if female) e. Total bilirubin ≤ 1.5 x ULN OR, for subjected with total bilirubin levels >1.5 x ULN, a direct bilirubin ≤ ULN f. AST and ALT ≤ 3 x UNL (unless elevated transaminases are felt to be directly related to metastatic disease involving the liver, in which case AST and ALT must be ≤ 5x ULN)
  • Women of childbearing potential (WOCBP) † must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 28 days of C1D1.
  • † A woman of childbearing potential is a sexually mature female who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months).
  • Effective contraception:
  • Women of childbearing potential must agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 120 days after the last dose of study therapy, or agree to completely abstain from heterosexual intercourse.
  • Male subjects, even if surgically sterilized (i.e., status post vasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study therapy, or agree to completely abstain from heterosexual intercourse.
  • Willing to comply with clinical trial instructions and requirements, including mandatory biopsies.

Who cannot join

  • Presence of targetable EGFR mutations or ALK re-arrangements.
  • All patients with adenocarcinoma histology must be tested for EGFR and ALK status, unless a KRAS mutation is detected in which case EGFR/ALK testing is not required.
  • History of allergy to study drug components or history of severe hypersensitivity reaction of any monoclonal antibody.
  • History of immune-related adverse event wit prior PD-1/PD-L1 therapy that required discontinuation of treatment
  • History of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
  • Any systemic anti-cancer therapy within 3 weeks prior to C1D1 of study therapy, with the following exception:
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  • Any prior investigational anti-cancer therapy is not permitted within 4 weeks of C1D1.
  • Ongoing adverse event from previously administered systemic anti-cancer therapy unless has recovered to ≤ grade 1 or at baseline prior to C1D1.
  • Subjects with any grade alopecia or ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
  • Patients who have not previously been treated with platinum-based based doublet chemotherapy and who, in the judgment of the investigator, have rapidly progressive disease such that serious complications may arise from disease progression within the next 12 weeks will be excluded.
  • Non-CNS radiotherapy within 1 week prior to C1D1 of study therapy
  • Active infection requiring systemic therapy
  • Known history of previous clinical diagnosis of tuberculosis.
  • Prior or current systemic immunosuppressive therapy (> 10 mg/day prednisone equivalents) within 7 days prior to C1D1 of study therapy. Inhaled, ocular, intra-articular, intranasal, and topical corticosteroids are permitted in absence of active autoimmune disease.
  • Adrenal replacement doses are permitted in the absence of active autoimmune disease.
  • Has diagnosis of immunodeficiency
  • History of allogeneic organ transplant.
  • Patients with known or suspected history of autoimmune disease.
  • Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, resolved childhood asthma/atopy, patients with asthma requiring intermittent bronchodilator therapy, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Other active malignancy that is progressing, requires concurrent intervention, and/or could be mistaken for the malignancy under study during disease assessments.
  • Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless definitive therapy has been completed at least 1 year prior to study entry and the patient is now without evidence of disease from that malignancy and no additional therapy is required or anticipated to be required during the study period.
  • Known untreated brain or leptomeningeal metastasis.
  • Patients with brain metastases are eligible if metastases have been adequately treated and neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least two weeks prior to C1D1 and meet requirements related to steroids noted in above Exclusions Criteria 6.2.10.
  • History of stroke or transient ischemic attack within the previous 6 months.
  • Any of the following cardiac abnormalities:
  • Unstable angina pectoris
  • Congestive heart failure ≥ NYHA Class 3
  • QTc ≥470 milliseconds calculated using Frediricia's Correction
  • Current or history of pericardial effusion causing hemodynamic compromise
  • Patients with a >/= small pericardial effusion at baseline will be excluded. Patients with < small pericardial effusion at baseline can continue to proceed onto treatment if other eligibility criteria are met
  • History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
  • Any positive test for HIV 1/2 antibodies and/or RNA.
  • Any positive test for hepatitis B virus(HBV) using HBV surface antigen (HBV sAG) test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  • Has received a live vaccine within 30 days of planned start of study therapy. a. Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • John Hopkins Medical Center

    Baltimore, Maryland, 21287

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111-2497

Other trials in United States

About this study

Official title: Phase I/Ib Study of Combined Pembrolizumab Plus Guadecitabine and Mocetinostat for Patients With Advanced NSCLC (DOSE SELECTION)

The purpose of this study is to test the safety of a combination of three drugs, pembrolizumab, guadecitabine and mocetinostat. Pembrolizumab is a drug given by vein and all patients will receive the same dose. Guadecitabine and mocetinostat will be given at different doses to find out what effects, if any, they have on treating your cancer and side effects.

Conditions
Lung Cancer
Being tested
Pembrolizumab, Guadecitabine, Mocetinostat
Keywords
Pembrolizumab, guadecitabine, mocetinostat, 17-241
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    Pembrolizumab will be administered at 200mg IV on day 1 of each 21 day cycle.

  • GuadecitabineDrug

    Guadecitabine will be administered subcutaneously given daily on days 1-5 of each cycle with escalating doses by cohort.

  • MocetinostatDrug

    Mocetinostat will be administered orally with escalating doses on days 8, 10, 13, 15, 17 and 20 of each cycle with escalating doses by cohort.

Study groups in NCT03220477
Study groupRoleWhat they receive
pembrolizumab plus guadecitabine and mocetinostatExperimentalPembrolizumab given IV; guadecitabine given SQ, mocetinostat given PO.
Receives: Drug: Pembrolizumab; Drug: Guadecitabine; Drug: Mocetinostat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of patients with adverse events

    events occurring on or after treatment on the first day of any study therapy will be summarized by dose cohort, toxicity term, CTCAE v4.0 grade

    Measured: 1 year

  2. response rate (Phase Ib)

    Tumor response will be assessed using RECIST 1.1. All responses must be confirmed on subsequent scan to be considered a true response.

    Measured: within 6 months of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2017
  2. Study start4 Aug 2017
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single-arm, open-label, multi-center, therapeutic study. All patients will be assigned to receive all three study therapies. The phase 1 portion of the study will proceed as a 3+3 dose-escalation with escalating doses of guadecitabine and mocetinostat, along with fixed dose of pembrolizumab.
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03220477
Sponsor's protocol ID
17-241
Status last verified
Aug 2026
First submitted
14 Jul 2017
Last updated
5 Aug 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pembrolizumab, Guadecitabine and Mocetinostat in people with Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of patients with adverse events (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03220477.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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