Randomised, Multicenter Phase III Clinical Study OfNanoplatin Plus Pemetrexed Versus Cisplatin Plus Pemetrexed As First Line Treatment In Inoperable (Stage III/IV) Non-Small Cell Lung Cancer Of Non-Squamous Type

Phase 1

• Conditions: Patients with Inoperable (Stage III/IV) Non-Small Cell Lung Cancer Of Non-Squamous Type not previously treated with chemotherapy related to the current disease; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-003612-24-GR
• Lead Sponsor: Regulon AE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-01
• Last Update Posted: 10 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 884

Inclusion Criteria

Adult male or female;18-75 years of age; histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC of other than predominantly squamous cell histology; at least one unidimentionally measurable lesion; no prior chemotherapy/other investigational drug treatment for current disease; performance status 0-1; life expectancy >3 months; adequate haematologic/hepatic/renal function; signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 284

Exclusion Criteria

oSquamous or undifferentiated NSCLC.
oEligibility for other curative intent treatment (e.g. surgery).
oOther malignancy within the past 5 years, except malignancies with <5% probability of recurrence, curatively treated squamous or basal cell skin carcinoma, or in situ carcinoma of the cervix.
oKnown allergy to any of the study drug components.
oPrior chemotherapy or investigational drug treatment for current disease.
oMalnutrition (>25% weight loss).
oRecent history of myocardial infarction (within the last 6 months), history of congestive heart failure, congenital heart disease, or ventricular arrhythmias.
oHistory of Hepatitis B or C (HBs Ag or anti-HCV).
oHIV seropositivity.
oKnown underlying immune deficiency or history of autoimmune diseases.
oPregnant or lactating women. For women of childbearing age an initial negative pregnancy test and usage of a reliable contraceptive method during and for 3 months after study participation is a requirement.
oAny medical, psychiatric or social condition that would preclude informed consent (e.g. homeless patients or with dementia).
oPatients for whom compliance with the protocol is doubtful

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified