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

March 23, 2023 updated by: National Cancer Institute, Naples

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

232

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alba, Italy
        • Ospedale San Lazzaro
      • Ancona, Italy
        • Ospedali Riunit Umberto I-Lancisi-Salesi
      • Aprilia, Italy
        • Oncologia Universitaria degli Studi di Roma
      • Asti, Italy
        • Ospedale Cardinal Massaia
      • Avellino, Italy
        • S. Giuseppe Moscati
      • Brindisi, Italy
        • Ospedale Senatore Antonio Perrino
      • Cagliari, Italy
        • Univeristaria Policlinico Monserrato di Cagliari
      • Campobasso, Italy
        • Ospedale A. Cardarelli
      • Camposampiero, Italy
        • U.L.S.S. 15 Veneto
      • Carpi, Italy
        • Ospedale Ramazzini di Carpi
      • Catania, Italy
        • Policlinico Vittorio Emanuele
      • Catania, Italy
        • Azienda Ospedaliera Garibalda Nesimadi Catania
      • Chioggia, Italy
        • Ospedale della Madonna della Navicella
      • Faenza, Italy
        • Ospedale Civile di Faenza
      • Frosinone, Italy
        • Ospedale Fabrizio Spaziani
      • Genova, Italy
        • Ospedale Villa Scassi
      • Genova, Italy
        • IRCCS AOU San Martino IST Genova
      • Lecce, Italy
        • Azienda Ospedaliera Vito Fazzi
      • Legnano, Italy
        • Ospedale Civile di Legnano
      • Lugo, Italy
        • Ospedale Umberto I
      • Meldola, Italy
        • IRCCS-Meldola
      • Milano, Italy
        • Ospedale L. Sacco Polo Universitario
      • Milano, Italy
        • Ospedale S. Paolo
      • Mirano, Italy
        • U.L.S.S. 13
      • Monza, Italy
        • H San Gerardo
      • Napoli, Italy
        • Seconda Universita di Napoli
      • Napoli, Italy
        • Istituto Nazionale dei Tumori
      • Napoli, Italy
        • A.O.U. Federico II
      • Napoli, Italy
        • Ospedale Cardirelli
      • Negrar, Italy
        • Istituto Sacro Cuore Don Calabria
      • Padova, Italy
        • Istituto Oncologico Veneto
      • Pagani, Italy
        • Ospedale Civile Umberto I
      • Palermo, Italy
        • Casa di Cura La Maddalena
      • Palermo, Italy
        • Azienda Ospedaleira Ospedali Riuniti Villa Sofia Cervello
      • Pavia, Italy
        • Fondazione Salvatore Maugeri
      • Potenza, Italy
        • A.O. San Carlo
      • Rionero in Vulture, Italy
        • Irccs - Crob
      • Roma, Italy
        • AO San Camillo Forlanini
      • Roma, Italy
        • Campus Biomedico
      • Roma, Italy
        • Ospedale S. Giovanni Calibita Fatebenfratelli
      • Saliceto, Italy
        • Ospedale Guglielmo da Saliceto-USL di Piacenza
      • San Giovanni Rotondo, Italy
        • Oncologia IRCCS - Casa Sollievo Sofferenza
      • Saronno, Italy
        • A.O. di Busto Arsizio
      • Sondrio, Italy
        • Ospedale di Sondrio
      • Sora, Italy
        • Ospedale SS. Trinità
      • Vercelli, Italy
        • Ospedale S. Andrea
      • Vicenza, Italy
        • Ospedale S. Bortolo
      • Viterbo, Italy
        • ASL Viterbo Ospedale Belcolle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A: Gemcitabine
Single agent gemcitabine dose 1200 mg/m2 days 1 and 8, every 3 weeks
Drug: Gemcitabine
Experimental: B: Gemcitabine + Cisplatin
Gemcitabine dose 1000 mg/m2 days 1 and 8, every 3 weeks
Drug: Gemcitabine
Drug: Cisplatin
60 mg/m2 day 1 every 3 weeks
Active Comparator: C: Pemetrexed
Drug: Pemetrexed
500 mg/m2 day 1 every 3 weeks
Experimental: D: Pemetrexed + Cisplatin
Drug: Cisplatin
60 mg/m2 day 1 every 3 weeks
Drug: Pemetrexed
500 mg/m2 day 1 every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: one year
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)
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: 6 months
6 months
objective response
Time Frame: after 9 and 18 weeks of therapy
after 9 and 18 weeks of therapy
worst grade toxicity per patient
Time Frame: evaluated at end of each 3 week cycle of chemotherapy up to 18 weeks
according to Common Toxicity Criteria for Adverse Events v. 4.03
evaluated at end of each 3 week cycle of chemotherapy up to 18 weeks
changes in quality of life
Time Frame: baseline and up to 18 weeks
baseline and up to 18 weeks

Other Outcome Measures

Outcome Measure
Time Frame
identification of patient and lesion specific prognostic factors
Time Frame: 2 years
2 years
identification of patient and lesion specific factors predictive of chemotherapy efficacy
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Naples

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2012

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

July 23, 2012

First Submitted That Met QC Criteria

July 31, 2012

First Posted (Estimate)

August 3, 2012

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MILES-4
  • 2012-000164-25 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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