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Non Small Cell Lung Cancer PatientsPhase 2MP-LALCNCT03379441

Pembrolizumab (MK-3475) as Maintainance in Treated Patients With Unresectable Stage III NSCLC

A Phase 2 study testing Pembrolizumab Injectable Product in people with Non Small Cell Lung Cancer Patients, run by University of Turin, Italy at 14 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Maintainance therapy in patients with unresectable stage III, NSCLC Stage IIIA-B, unresectable, NSCLC, treated with definitive Chemo-Radiotherapy Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non Small Cell Lung Cancer Patients
What is being tested?
Pembrolizumab Injectable Product
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
14 sitesItaly
Study dates
1 Jan 2018to 1 Jan 2023
Phase
Phase 2
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be willing and able to provide written informed consent/assent for the trial.
  • Be > 18 years of age on day of signing informed consent.
  • Have measurable disease based on RECIST 1.1.
  • Be willing to provide tissue from a newly obtained core, trucut biopsy or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the PI.
  • Have a performance status of 0 or 1 on the ECOG Performance Scale.
  • Demonstrate adequate organ function , all screening labs should be performed within 10 days of treatment initiation.
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  • Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication (Section 8.14.2). Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
  • Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy

Who cannot join

  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  • Has a known history of active Bacillus Tuberculosis (TB)
  • Hypersensitivity to pembrolizumab or any of its excipients.
  • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
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  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). 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 a history of (non-infectious) pneumonitis that required steroids or current pneumonitis, or has evidence of interstitial lung disease.
  • Has an active infection requiring systemic therapy.
  • 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 prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Has known active Hepatitis B (e.g., hepatitis B virus surface antigen [HBsAg] reactive) or Hepatitis C (e.g., HCV ribonucleic acid [RNA] qualitative is detected).
  • Has received a live vaccine within 30 days of planned start of study therapy.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Italy14 sites

  • CRO Aviano

    Aviano, Pordenone, 33081

    Alessandra Bearz, MD

  • Istituto Tumori Giovanni Paolo II

    Bari, 70124

    Domenico Galetta, MD

  • Chieti Università degli Studi "G. D'Annunzio"

    Chieti, 66100

    Clara Natoli, MD

  • AOU Careggi

    Florence, 50134

    Lorenzo Livi, MD

  • IRCCS AO San Martino

    Genova, 16132

    Francesco Grossi, MD

  • Azienda Ospedaliera Papardo

    Messina, 98158

    Vincenzo Adamo, MD

  • Istituto Clinico Humanitas

    Milan, 20089

    Armando Santoro, MD

  • Ospedale San Raffaele

    Milan, 20132

    Vanesa Gregorc, MD

  • Policlinico Modena

    Modena

    Stefano Cascinu, MD

  • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

    Naples, 80131

    Alessandro Morabito, MD

  • AOU San Luigi- Department of Oncology

    Orbassano, Turin, 10043

  • Policlinico Universitario Campus Biomedico

    Roma, 00128

    Sara Ramella, MD

  • PO Centrale

    Taranto, 74100

    Salvatore Pisconti, MD

  • Policlinico Verona Borgo Roma

    Verona, 37134

    Emilio Bria, MD

Other trials in Italy

About this study

Official title: A Randomized Phase II Study of Pembrolizumab (MK-3475) as Maintainance Therapy in Patients With Unresectable Stage III Non-small Cell Lung Cancer Treated With Definitive Chemo-radiotherapy

Maintainance therapy in patients with unresectable stage III, NSCLC Stage IIIA-B, unresectable, NSCLC, treated with definitive Chemo-Radiotherapy

Read the detailed description

This is an Italian multi-center randomized phase II trial (randomization 2:1) of intravenous (IV) MK-3475 (Pembrolizumab) versus observation as a maintenance therapy after chemo-radiotherapy (either concomitant or sequential, regardless of the type of chemotherapy used) in unresectable stage IIIA-IIIB non small cell lung cancer (NSCLC) patients.

Being tested
Pembrolizumab Injectable Product

What participants receive

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

  • Pembrolizumab Injectable ProductDrug

    Pembrolizumab Injectable Product 200 mg Q3W Intravenous

Study groups in NCT03379441
Study groupRoleWhat they receive
ExperimentalExperimentalPembrolizumab 200 mg Q3W IV infusion Day 1 of each 3 week cycle until: * PD, * unacceptable toxicity, * investigator choice, * patients IC withdrawal, * up to a maximum of 24 months (35 administrations) Experimental
Receives: Drug: Pembrolizumab Injectable Product
ObservationNo interventionNot described

What is being measured

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

  1. OS

    The primary objective is to evaluate if treatment with chemo-radiotherapy followed by Pembrolizumab (MK-3475) maintenance (up to 24 months) results in superior Overall Survival (OS) in stage IIIA-B, unresectable, NSCLC compared to chemo-radiotherapy (CT-RT) followed by observation

    Measured: up to 24 months per patient

Secondary outcomes (1)

  1. PFS

    To evaluate Rate (%) of patients without disease progression at 12, 18 and 24 months

    Measured: up to 24 months per patient

Timeline

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

  1. First posted20 Dec 2017
  2. Study start1 Jan 2018 (estimated)
  3. Primary completion1 Jan 2023 (estimated)
  4. Study completion1 Jan 2023 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03379441
Sponsor's protocol ID
2016-001252-22
Other IDs
2016
Acronym
MP-LALC
Status last verified
Dec 2017
First submitted
23 Nov 2017
Last updated
22 Dec 2017
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab Injectable Product in people with Non Small Cell Lung Cancer Patients, run by University of Turin, Italy at 14 sites in Italy.

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 9 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Italy. 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 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?

Results are not available in the source record.

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?

OS (time frame: up to 24 months per patient). 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 NCT03379441.

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 22 Dec 2017.

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