Advanced non-small cell lung cancer
Conditions
Interventions
Trade Name: Alimta
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Karboplatin
Other descriptive name: CARBOPLATIN
Concentration unit: mg milligram(s)
Concentration typ
Sponsors
Norwegian University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: See principal inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Progression free survival • Toxicity • Health related quality of life ;Timepoint(s) of evaluation of this end point: Evaluation with CT-scan after 6 and 12 weeks after randomization, and thereafter every 9 week. Evaluation of toxicity during each treatment cycle. Evaluation of health related quality of life before every second treatment cycle | — |
Countries
Norway
Contacts
Public ContactSveinung Sørhaug
Norwegian University of Science and Technology
Outcome results
None listed