Maintenance therapy in advanced Lung Cancer.
- Conditions
- Advanced non-small cell lung cancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-001237-41-NO
- Lead Sponsor
- orwegian University of Science and Technology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1.No prior systemic therapy for advanced non-small-cell lung cancer (including EGFR-TKI). Previous chemotherapy (e.g. adjuvant after surgery or for other cancer) is allowed if = 3 months since the last course was administered.
2.Measureable disease according to the RECIST 1.1
3.Previous radiotherapy is acceptable provided there are measurable, previously not irradiated lesions present.
4.Histologically or cytologically confirmed non-squamous non-small cell lung cancer
5.No activating EGFR-mutation or ALK-translocation detected
6.Stage IIIB ineligible for curative therapy or stage IV disease
7.Age = 18 years
8.ECOG Performance 0-2
9.Adequate organ function defined as:
a.Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) = 3 x upper limit of normal (ULN), or AST and ALT = 5 x ULN if liver function abnormalities are due to underlying malignancy.
b.Total serum bilirubin = 1.5 x ULN
c.Absolute neutrophil count (ANC) = 1.5 x 109/L
d.Platelets = 100 x 109/L
e.Creatinin clearance > 45 ml/min
10.No serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) that in the opinion of the investigator would compromise the patient’s ability to complete the study or interfere with the evaluation of the efficacy and safety of the study treatment
11.No conditions – medical, social, psychological – which could prevent adequate information and follow-up
12.No clinical active cancer other than NSCLC
13.No known hypersensitivity or contraindications for the study drugs (vinorelbine, carboplatin, pemetrexed, B12, folate,)
14.Able to discontinue NSAIDs and ASA if reduced renal function
15.No pregnancy or lactating women
16.All fertile patients should use safe contraception
17.Written 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 465
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300
See principal inclusion criteria
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The overall aim is to investigate whether immediate maintenance pemetrexed therapy prolongs survival compared to observation and pemetrexed therapy at progression in patients with advanced NSCLC. ;Secondary Objective: Furthermore, we will explore whether patients with PS 2 and elderly = 70 years tolerate and benefit from maintenance therapy; and what clinical characteristics and blood biomarkers are associated with sensitivity and tolerability of such therapy.;Primary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: Continuously evaluation during the study. Last follow-up 24 months after last patient included.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Progression free survival<br>•Toxicity<br>•Health related quality of life<br>;Timepoint(s) of evaluation of this end point: Evaluation with CT-scan after 6 and 12 weeks after randomization, and thereafter every 9 week.<br>Evaluation of toxicity during each treatment cycle.<br>Evaluation of health related quality of life before every second treatment cycle