EUCTR2011-003612-24-GRActive, not recruitingPhase 1
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
Regulon AE0 sites884 target enrollmentStarted: February 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 884
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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