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

Non-small Cell Lung Cancer Metastatic Clinical Trial

— MILES-4  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01656551
• Other study ID #: MILES-4
• Secondary ID: 2012-000164-25
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 2012
• Est. completion date: November 2024

Study information

• Verified date: March 2023
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 patients with non squamous NSCLC.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 232
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer Metastatic
• Non-small Cell Lung Cancer Stage IIIB

Intervention

Drug:
• Gemcitabine

• Pemetrexed
500 mg/m2 day 1 every 3 weeks
• Cisplatin
60 mg/m2 day 1 every 3 weeks

Locations

Country	Name	City	State
Italy	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	Milano
Italy	Ospedale S. Paolo	Milano
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	Padova
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

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	identification of patient and lesion specific prognostic factors		2 years
Other	identification of patient and lesion specific factors predictive of chemotherapy efficacy		2 years
Primary	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)	one year
Secondary	worst grade toxicity per patient	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
Secondary	progression free survival		6 months
Secondary	changes in quality of life		baseline and up to 18 weeks
Secondary	objective response		after 9 and 18 weeks of therapy