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Non-small Cell Lung Cancer MetastaticPhase 3MILES-4NCT01656551

MILES-4: Study Comparing Gemcitabine and Pemetrexed, With or Without Cisplatin, in Patients With Nonsquamous Lung Cancer

A Phase 3 study testing Gemcitabine, Pemetrexed and Cisplatin in people with Non-small Cell Lung Cancer Metastatic and Non-small Cell Lung Cancer Stage IIIB, run by National Cancer Institute, Naples at 48 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purposes of this study are to test whether the addition of cisplatin to single agent chemotherapy (either gemcitabine or pemetrexed) prolongs survival in elderly patients with non squamous non small cell lung cancer (NSCLC), and to test whether pemetrexed prolongs survival as compared to gemcitabine in elderly… Read more about this study

Who is it for?
Ages 70 years and older
What is being tested?
Gemcitabine, Pemetrexed and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
232 participants
Where
48 sitesItaly
Study dates
Aug 2012to Nov 2024
Phase
Phase 3
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Diagnosis of cytologically or histologically confirmed non-small cell lung cancer.
  • Non squamous tumor type (including those with a non-specified tumor type).
  • Metastatic (stage IV, both M1A or M1B) or locally advanced (stage IIIB, with metastasis to supraclavicular nodes) according to TNM VII edition.
  • Both patients at first diagnosis or those with disease recurrence after former surgery are eligible.
  • At least one target or non-target lesion according to RECIST revised version 1.1.
  • Male or female > or = 70 years of age.
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  • ECOG PS 0 or 1.
  • Life expectancy > 3 months.
  • Neutrophils > or = 1500 mm3, platelets > or = 100000 mm3, and haemoglobin > or = 9 g/dL.
  • Bilirubin level either normal or < 1.5 x ULN.
  • AST (SGOT) and ALT (SGPT) < or = 2.5 x ULN (< or = 5 x ULN if liver metastasis are present).
  • Serum creatinine < 1.5 x ULN.
  • Signed written informed consent.

Who cannot join

  • Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease. Prior surgery and/or localised irradiation is permitted. Prior adjuvant chemotherapy is permitted if it did not contain gemcitabine and pemetrexed and if at least 6 months elapsed from the end of adjuvant chemotherapy.
  • Any unstable systemic disease (including active infections, significant cardiovascular disease or myocardial infarction within the previous year, any significant hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study medications or render the patient at high risk from treatment complications.
  • Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal PSA).
  • Patients with symptomatic brain metastasis or spinal cord compression that has not yet been treated with surgery and/or radiation; patients with CNS metastases or spinal cord compression previously treated with surgery and/or radiation are eligible if they are asymptomatic and do not require steroids (anti-seizure medications are allowed).
  • Known or suspected hypersensitivity to any of the study drugs

Trial locations and contacts

48 sites in 1 country.

48 sites in 1 country

Italy48 sites

  • Ospedale San Lazzaro

    Alba

  • Ospedali Riunit Umberto I-Lancisi-Salesi

    Ancona

  • Oncologia Universitaria degli Studi di Roma

    Aprilia

  • Ospedale Cardinal Massaia

    Asti

  • S. Giuseppe Moscati

    Avellino

  • Ospedale Senatore Antonio Perrino

    Brindisi

  • Univeristaria Policlinico Monserrato di Cagliari

    Cagliari

  • Ospedale A. cardarelli

    Campobasso

  • U.L.S.S. 15 Veneto

    Camposampiero

  • Ospedale Ramazzini di Carpi

    Carpi

  • Azienda Ospedaliera Garibalda Nesimadi Catania

    Catania

  • Policlinico vittorio Emanuele

    Catania

  • Ospedale della Madonna della Navicella

    Chioggia

  • Ospedale Civile di Faenza

    Faenza

  • Ospedale Fabrizio Spaziani

    Frosinone

  • IRCCS AOU San Martino IST Genova

    Genova

  • Ospedale Villa Scassi

    Genova

  • Azienda Ospedaliera Vito Fazzi

    Lecce

  • Ospedale Civile di Legnano

    Legnano

  • Ospedale Umberto I

    Lugo

  • IRCCS-Meldola

    Meldola

  • Ospedale L. Sacco Polo Universitario

    Milan

  • Ospedale S. Paolo

    Milan

  • U.L.S.S. 13

    Mirano

  • H San Gerardo

    Monza

  • A.O.U. Federico II

    Naples

  • Istituto Nazionale dei Tumori

    Naples

  • Ospedale Cardirelli

    Naples

  • Seconda Università di Napoli

    Naples

  • Istituto Sacro Cuore Don Calabria

    Negrar

  • Istituto Oncologico Veneto

    Padova

  • Ospedale Civile Umberto I

    Pagani

  • Azienda Ospedaleira Ospedali Riuniti Villa Sofia Cervello

    Palermo

  • Casa di cura La Maddalena

    Palermo

  • Fondazione Salvatore Maugeri

    Pavia

  • A.O. San Carlo

    Potenza

  • Irccs - Crob

    Rionero in Vulture

  • AO San Camillo Forlanini

    Roma

  • Campus Biomedico

    Roma

  • Ospedale S. Giovanni Calibita Fatebenfratelli

    Roma

  • Ospedale Guglielmo da Saliceto-USL di Piacenza

    Saliceto

  • Oncologia IRCCS - Casa Sollievo Sofferenza

    San Giovanni Rotondo

  • A.O. di Busto Arsizio

    Saronno

  • Ospedale di Sondrio

    Sondrio

  • Ospedale SS. Trinità

    Sora

  • Ospedale S. Andrea

    Vercelli

  • Ospedale S. Bortolo

    Vicenza

  • ASL Viterbo Ospedale Belcolle

    Viterbo

Other trials in Italy

About this study

Official title: A Factorial Study Comparing Pemetrexed With Gemcitabine and Testing the Efficacy of the Addition of Cisplatin in Elderly Patients With Non Squamous Advanced, Metastatic or Recurrent NSCLC.

The purposes of this study are to test whether the addition of cisplatin to single agent chemotherapy (either gemcitabine or pemetrexed) prolongs survival in elderly patients with non squamous non small cell lung cancer (NSCLC), and to test whether pemetrexed prolongs survival as compared to gemcitabine in elderly patients with non squamous NSCLC.

Keywords
elderly, chemotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

Study groups in NCT01656551
Study groupRoleWhat they receive
A: GemcitabineActive comparatorSingle agent gemcitabine dose 1200 mg/m2 days 1 and 8, every 3 weeks
Receives: Drug: Gemcitabine
B: Gemcitabine + CisplatinExperimentalGemcitabine dose 1000 mg/m2 days 1 and 8, every 3 weeks
Receives: Drug: Gemcitabine; Drug: Cisplatin
C: PemetrexedActive comparatorNot described
Receives: Drug: Pemetrexed
D: Pemetrexed + CisplatinExperimentalNot described
Receives: Drug: Pemetrexed; Drug: Cisplatin

What is being measured

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

  1. overall survival

    factorial design with two comparisons: single agent chemotherapy versus chemotherapy plus cisplatin (Arms A+C versus Arms B + D), and gemcitabine versus pemetrexed (Arms A+B versus Arms C+D)

    Measured: one year

Secondary outcomes (4)

  1. worst grade toxicity per patient

    according to Common Toxicity Criteria for Adverse Events v. 4.03

    Measured: evaluated at end of each 3 week cycle of chemotherapy up to 18 weeks

  2. progression free survival

    Measured: 6 months

  3. changes in quality of life

    Measured: baseline and up to 18 weeks

  4. objective response

    Measured: after 9 and 18 weeks of therapy

Timeline

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

  1. First posted3 Aug 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionNov 2024 (estimated)
  4. Study completionNov 2024 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
232 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01656551
Sponsor's protocol ID
MILES-4
Other IDs
2012-000164-25
Acronym
MILES-4
Status last verified
Mar 2023
First submitted
23 Jul 2012
Last updated
24 Mar 2023
Results posted
No
Data monitoring committee
No

Publications

  • Gridelli C, Morabito A, Cavanna L, Luciani A, Maione P, Bonanno L, Filipazzi V, Leo S, Cinieri S, Ciardiello F, Burgio MA, Bilancia D, Cortinovis D, Rosetti F, Bianco R, Gebbia V, Artioli F, Bordonaro R, Fregoni V, Mencoboni M, Nelli F, Riccardi F, di Isernia G, Costanzo R, Rocco G, Daniele G, Signoriello S, Piccirillo MC, Gallo C, Perrone F. Cisplatin-Based First-Line Treatment of Elderly Patients With Advanced Non-Small-Cell Lung Cancer: Joint Analysis of MILES-3 and MILES-4 Phase III Trials. J Clin Oncol. 2018 Sep 1;36(25):2585-2592. doi: 10.1200/JCO.2017.76.8390. Epub 2018 Jul 20.

    PubMed 30028656

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gemcitabine, Pemetrexed and Cisplatin in people with Non-small Cell Lung Cancer Metastatic and Non-small Cell Lung Cancer Stage IIIB, run by National Cancer Institute, Naples at 48 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 13 inclusion and 5 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 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

overall survival (time frame: one year). 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 NCT01656551, which also lists 1 linked publication.

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 24 Mar 2023.

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