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

NCT ID: NCT01656551

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 232 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2024-11-30

Brief 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 patients with non squamous NSCLC.

Conditions

Non-small Cell Lung Cancer Metastatic; Non-small Cell Lung Cancer Stage IIIB

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A: Gemcitabine

Single agent gemcitabine dose 1200 mg/m2 days 1 and 8, every 3 weeks

Group Type: ACTIVE_COMPARATOR

Gemcitabine

Intervention Type: DRUG

B: Gemcitabine + Cisplatin

Gemcitabine dose 1000 mg/m2 days 1 and 8, every 3 weeks

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

Cisplatin

Intervention Type: DRUG

60 mg/m2 day 1 every 3 weeks

C: Pemetrexed

Group Type: ACTIVE_COMPARATOR

Pemetrexed

Intervention Type: DRUG

500 mg/m2 day 1 every 3 weeks

D: Pemetrexed + Cisplatin

Group Type: EXPERIMENTAL

Pemetrexed

Intervention Type: DRUG

500 mg/m2 day 1 every 3 weeks

Cisplatin

Intervention Type: DRUG

60 mg/m2 day 1 every 3 weeks

Interventions

Gemcitabine

Intervention Type: DRUG

Pemetrexed

500 mg/m2 day 1 every 3 weeks

Intervention Type: DRUG

Cisplatin

60 mg/m2 day 1 every 3 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Naples

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cesare Gridelli, M.D.

Role: PRINCIPAL_INVESTIGATOR

S.G. Moscati Hopital, Avellino, Italy, Division of Medical Oncology

Francesco Perrone, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute Naples, Italy; Director Clinical Trials Unit

Ciro Gallo, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Second University of Naples, Italy; Chair of Medical Statistics

Massimo Di Maio, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute, Naples

Locations

Ospedale San Lazzaro

Alba, , Italy

Ospedali Riunit Umberto I-Lancisi-Salesi

Ancona, , Italy

Oncologia Universitaria degli Studi di Roma

Aprilia, , Italy

Ospedale Cardinal Massaia

Asti, , Italy

S. Giuseppe Moscati

Avellino, , Italy

Ospedale Senatore Antonio Perrino

Brindisi, , Italy

Univeristaria Policlinico Monserrato di Cagliari

Cagliari, , Italy

Ospedale A. cardarelli

Campobasso, , Italy

U.L.S.S. 15 Veneto

Camposampiero, , Italy

Ospedale Ramazzini di Carpi

Carpi, , Italy

Azienda Ospedaliera Garibalda Nesimadi Catania

Catania, , Italy

Policlinico vittorio Emanuele

Catania, , Italy

Ospedale della Madonna della Navicella

Chioggia, , Italy

Ospedale Civile di Faenza

Faenza, , Italy

Ospedale Fabrizio Spaziani

Frosinone, , Italy

IRCCS AOU San Martino IST Genova

Genova, , Italy

Ospedale Villa Scassi

Genova, , Italy

Azienda Ospedaliera Vito Fazzi

Lecce, , Italy

Ospedale Civile di Legnano

Legnano, , Italy

Ospedale Umberto I

Lugo, , Italy

IRCCS-Meldola

Meldola, , Italy

Ospedale L. Sacco Polo Universitario

Milan, , Italy

Ospedale S. Paolo

Milan, , Italy

U.L.S.S. 13

Mirano, , Italy

H San Gerardo

Monza, , Italy

A.O.U. Federico II

Napoli, , Italy

Istituto Nazionale dei Tumori

Napoli, , Italy

Ospedale Cardirelli

Napoli, , Italy

Seconda Università di Napoli

Napoli, , Italy

Istituto Sacro Cuore Don Calabria

Negrar, , Italy

Istituto Oncologico Veneto

Padua, , Italy

Ospedale Civile Umberto I

Pagani, , Italy

Azienda Ospedaleira Ospedali Riuniti Villa Sofia Cervello

Palermo, , Italy

Casa di cura La Maddalena

Palermo, , Italy

Fondazione Salvatore Maugeri

Pavia, , Italy

A.O. San Carlo

Potenza, , Italy

Irccs - Crob

Rionero in Vulture, , Italy

AO San Camillo Forlanini

Roma, , Italy

Campus Biomedico

Roma, , Italy

Ospedale S. Giovanni Calibita Fatebenfratelli

Roma, , Italy

Ospedale Guglielmo da Saliceto-USL di Piacenza

Saliceto, , Italy

Oncologia IRCCS - Casa Sollievo Sofferenza

San Giovanni Rotondo, , Italy

A.O. di Busto Arsizio

Saronno, , Italy

Ospedale di Sondrio

Sondrio, , Italy

Ospedale SS. Trinità

Sora, , Italy

Ospedale S. Andrea

Vercelli, , Italy

Ospedale S. Bortolo

Vicenza, , Italy

ASL Viterbo Ospedale Belcolle

Viterbo, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 30028656 (View on PubMed)

Other Identifiers

2012-000164-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MILES-4

Identifier Type: -

Identifier Source: org_study_id