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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.


Phase 3
70 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer Metastatic, Non-small Cell Lung Cancer Stage IIIB

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Description:

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)

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Cesare Gridelli, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Italy: Ethics Committee

Study ID:

MILES-4

NCT ID:

NCT01656551

Start Date:

July 2012

Completion Date:

July 2014

Related Keywords:

  • Non-small Cell Lung Cancer Metastatic
  • Non-small Cell Lung Cancer Stage IIIB
  • elderly
  • chemotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasms
  • Neoplasms, Second Primary

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