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Small-cell Lung CancerPhase 1/2NCT03371979

Pegzilarginase and Pembrolizumab for Extensive Disease Small Cell Lung Cancer

A Phase 1/2 study testing Pegzilarginase and Pembrolizumab in people with Small-cell Lung Cancer, run by Immedica Pharma AB at 22 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The main purpose of this Phase 1/2 study is to determine the safety and efficacy of pegzilarginase in combination with pembrolizumab in patients with ED-SCLC who have relapsed or progressive disease on or within 6 months of platinum-based chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small-cell Lung Cancer
What is being tested?
Pegzilarginase and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
22 sitesin 2 countries
Study dates
21 Dec 2017to 11 Jun 2020
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 is able and willing to provide written informed consent
  • Be > 18 years of age on day of signing informed consent
  • Have histologically or cytologically confirmed SCLC that meets:
  • Extensive disease per criteria of the International Association for the Study of Lung Cancer (IASLC)-American Joint Committee on Cancer (AJCC) TNM staging system
  • Have not tolerated or have progressed or relapsed on or within 6 months of platinum-based chemotherapy
  • Have a performance status of ≤ 1 on the ECOG Performance Scale
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  • Have measurable disease based on RECIST 1.1
  • Willing to undergo core needle or incisional biopsy to obtain fresh tumor tissue specimens
  • Demonstrate adequate organ function as evidenced by laboratory testing with specimens collected within 10 days prior to day 1 of cycle 1
  • Must have recovered from the effects of any prior systemic therapy, radiotherapy or surgery to Grade 1 or less
  • If received major surgery or radiation therapy of > 30 Gy, recovered from the toxicity and/or complications from the intervention is required
  • Female child-bearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication
  • Sexually active male or female must be surgically sterile post-menopausal, or must agree to use a physician-approved method of birth control during the study through a minimum of 120 days after the last study drug administration.

Who cannot join

  • Has received more than 2 platinum-based regimens against SCLC
  • Has received pembrolizumab, or prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody as part of any previous therapy, including trials
  • Has participated in Merck MK-3475 (pembrolizumab) clinical trials
  • Has received pegzilarginase as part of any previous therapy
  • Is currently participating in a study of an investigational agent or received the last dose of an investigational agent within 4 weeks prior to the first dose of treatment in this study (a shorter interval for kinase inhibitors or other short half-life drugs could be considered after approval from the Sponsor). Is currently participating in a study of an investigational device within 4 weeks of the first dose of treatment
  • Has a diagnosis of an immunodeficiency, is receiving systemic steroid therapy (except for physiological dose levels), or immunosuppressive therapies
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  • Has had a prior monoclonal antibody (mAb) within 4 weeks prior to first dose or who has not recovered (i.e., ≤ Grade 1) from adverse reactions due to agents administered more than 4 weeks earlier
  • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose or who has not recovered (i.e., ≤ Grade 1 or at baseline) from treatment-emergent adverse reactions due to a previously administered agent
  • If the patient has undergone major surgery, must have recovered adequately from the toxicity and/or complications prior to starting therapy
  • Has received transfusion of blood products or administration of colony stimulating factors within 14 days prior to first study dose
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer) that has undergone potentially curative therapy
  • Has known central nervous system (CNS) metastases. However, patients with previously treated brain metastases may participate provided neurologic symptoms have stabilized, there is no evidence of new brain metastases or hemorrhage and they are not using steroids for brain metastases or for complications derived from their treatment for at least 7 days prior to the first dose of study treatment
  • Has known carcinomatous meningitis
  • Has an active autoimmune disease requiring systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs) or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo or resolved childhood asthma/atopy are an exception to this rule. Patients that require intermittent use of bronchodilators or local steroid injections will not be excluded from the study. Patients with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study. 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
  • Has evidence of interstitial lung disease, history of non-infectious pneumonitis that required steroids, or current pneumonitis
  • Has an active infection requiring systemic therapy
  • Inadequately controlled hypertension (defined as systolic blood pressure ≥ 200 mmHg and/or diastolic blood pressure ≥ 120 mmHg) on more than one occasion in the month before planned day of infusion
  • Currently taking 3 or more anti-hypertensive medications
  • Prior history of hypertensive crisis or hypertensive encephalopathy
  • History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or cardiac or vascular surgery within 6 months prior to day 1 of study treatment
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient 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 a known history of Human Immunodeficiency Virus (HIV) (positive for HIV p24 antigen or HIV 1/2 antibodies)
  • Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected)
  • Has received a live-virus vaccination within 30 days prior to the planned first dose of study therapy
  • Has a known history of active tuberculosis (Bacillus tuberculosis)
  • Has a history of hypersensitivity to PEG or any component of the pegzilarginase formulation
  • Severe hypersensitivity (≥ Grade 3) to any excipient of pegzilarginase or pembrolizumab
  • Has had an allogenic tissue/solid organ transplant.

Trial locations and contacts

22 sites in 2 countries.

22 sites in 2 countries

United States21 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University

    Atlanta, Georgia, 30307

  • University of Colorado

    Aurora, Colorado, 80045

  • Oncology & Hematology Associates of SW Virginia

    Blacksburg, Virginia, 24060

  • Charleston Hematology Oncology Associates

    Charleston, South Carolina, 29414

  • Oncology Hematology Care Inc.

    Cincinnati, Ohio, 45242

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • West Clinic

    Germantown, Tennessee, 38138

  • Texas Oncology-Memorial City

    Houston, Texas, 77024

  • University of Alabama, Mitchell Cancer Institute

    Mobile, Alabama, 36604

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • Mid Florida Hematology and Oncology Centers

    Orange City, Florida, 32763

  • The Valley Hospital, Luckow Pavilion

    Paramus, New Jersey, 07652

  • Woodlands Medical Specialists, PA

    Pensacola, Florida, 32503

  • UPMC Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Providence Cancer Center

    Portland, Oregon, 97213

  • Washington University

    St Louis, Missouri, 63110

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Texas Oncology-Tyler

    Tyler, Texas, 75702

Other trials in United States

Puerto Rico1 site

  • Fundacion De Investigacion, Hematology/Oncology

    San Juan, Puerto Rico, 00927

Other trials in Puerto Rico

About this study

Official title: A Phase 1/2 Study of Pegzilarginase (AEB1102, Co-ArgI-PEG) in Combination With Pembrolizumab in the Treatment of Patients With Extensive Disease (ED) Small Cell Lung Cancer (SCLC)

The main purpose of this Phase 1/2 study is to determine the safety and efficacy of pegzilarginase in combination with pembrolizumab in patients with ED-SCLC who have relapsed or progressive disease on or within 6 months of platinum-based chemotherapy.

Read the detailed description

Main purpose of this Phase 1/2 study is to determine the safety and efficacy of pegzilarginase in combination with pembrolizumab in patients with ED-SCLC who have relapsed or progressive disease on or within 6 months of platinum-based chemotherapy.

Being tested
Pegzilarginase, Pembrolizumab
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • PegzilarginaseDrug

    Also called AEB1102 (Co-ArgI-PEG)

    Administered IV

  • PembrolizumabDrug

    Also called MK-3475, Keytruda

    Administered IV

Study groups in NCT03371979
Study groupRoleWhat they receive
Pegzilarginase plus PembrolizumabExperimentalPhase 1 \& 2
Receives: Drug: Pegzilarginase; Drug: Pembrolizumab

What is being measured

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

  1. Phase 1: Incidence of Treatment-realted Adverse Events as Assessed by CTCAE v4.0

    Number of participants experiencing treatment-related adverse events as assessed by CTCAE v4.0.

    Measured: Estimated up to 6 months

Secondary outcomes (1)

  1. Phase 2: Incidence of Treatment-related Adverse Events as Assessed by CTCAE v4.0

    Number of participants experiencing treatment-related adverse events as assessed by CTCAE v4.0.

    Measured: From first treatment up to 24 months

Timeline

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

  1. First posted13 Dec 2017
  2. Study start21 Dec 2017
  3. Primary completion11 Jun 2020
  4. Study completion11 Jun 2020

Why it stopped: Study enrollment was halted early based on ongoing data monitoring; no efficacy analyses were performed

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03371979
Sponsor's protocol ID
CAEB1102-101B; KEYNOTE PN758
Status last verified
Oct 2026
First submitted
20 Nov 2017
Last updated
28 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pegzilarginase and Pembrolizumab in people with Small-cell Lung Cancer, run by Immedica Pharma AB at 22 sites in 2 countries.

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 13 inclusion and 30 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: stopped early, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, Puerto Rico. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Phase 1: Incidence of Treatment-realted Adverse Events as Assessed by CTCAE v4.0 (time frame: Estimated up to 6 months). 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 NCT03371979.

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 28 Oct 2026.

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