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.

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. - MILES-4

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000164-25-IT

Enrollment

550

Registered

2012-03-08

Start date

2012-06-14

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

elderly patients with non squamous advanced, metastatic or recurrent NSCLC MedDRA version: 14.1 Level: PT Classification code 10025038 Term: Lung adenocarcinoma stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10023780 Term: Large cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: ALIMTA*1FL POLV 500MG Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: NA CAS Number: NA Current Sponsor code: na Other descriptive name: NA Concentration unit: m

Eligibility

Sex/Gender

All

Inclusion 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 version 1.1. · Male or female ³ 70 years of age. · ECOG PS 0 or 1. · Life expectancy of > 3 months. · Neutrophils ³ 1.5 x 109/L, platelets ³ 100 x 109/L, and hemoglobin ³ 9 g/dL. · Bilirubin level either normal or =65 years) yes F.1.3.1 Number of subjects for this age range 550

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To test whether the addition of cisplatin to single agent chemotherapy (gemcitabine or pemetrexed) prolongs survival as compared to single agent chemotherapy in elderly patients with non squamous NSCLC. To test whether pemetrexed prolongs survival as compared to gemcitabine in elderly patients with non squamous NSCLC.;Secondary Objective: To compare toxicity within each planned comparison. To compare progression-free survival within each planned comparison. To compare response rate within each planned comparison. To compare quality of life within each planned comparison. To conduct exploratory analyses for the identification of prognostic and predictive factors of the efficacy of pemetrexed and cisplatin;Primary end point(s): overall survival;Timepoint(s) of evaluation of this end point: Every 3 weeks in the treatment; every 12 weeks last treatment	—

Measure

Time frame

Main Objective: To test whether the addition of cisplatin to single agent chemotherapy (gemcitabine or pemetrexed) prolongs survival as compared to single agent chemotherapy in elderly patients with non squamous NSCLC. To test whether pemetrexed prolongs survival as compared to gemcitabine in elderly patients with non squamous NSCLC.;Secondary Objective: To compare toxicity within each planned comparison. To compare progression-free survival within each planned comparison. To compare response rate within each planned comparison. To compare quality of life within each planned comparison. To conduct exploratory analyses for the identification of prognostic and predictive factors of the efficacy of pemetrexed and cisplatin;Primary end point(s): overall survival;Timepoint(s) of evaluation of this end point: Every 3 weeks in the treatment; every 12 weeks last treatment

—

Secondary

Measure	Time frame
Secondary end point(s): toxicity; progression-free survival; response rate; quality of life.;Timepoint(s) of evaluation of this end point: Every 3 weeks in the treatment; every 12 weeks last treatment	—

Countries

Italy

Contacts

Public ContactSC Sperimentazioni Cliniche

Istituto Nazionale per lo studio e la Cura dei Tumori - Napoli

segreteria@usc-intnapoli.net081 5903 571

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026