Carcinoma, Non-small-cell Lung Clinical Trial
— IDAOfficial title:
Maintenance Pemetrexed Therapy After Induction Chemotherapy Versus Pemetrexed at Progression in Advanced Non-Small-Cell Lung Cancer: A Randomized Phase III Study
Verified date | June 2020 |
Source | Norwegian University of Science and Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Non-small-cell lung cancer (NSCLC) accounts for a majority (approximately 85%) of lung cancer
cases. Patients with localized disease can be cured through surgery, but only 20 % are
operable.For the majority of patients with advanced disease, palliative cytotoxic
chemotherapy remains the recommended therapy. Chemotherapy prolongs survival and improves
quality of life.
The recommended first-line therapy is 4-6 courses of a platinum in combination with a third
generation compound (e.g. gemcitabine, vinorelbine, docetaxel, pemetrexed, paclitaxel). After
first-line therapy, it has been recommended to observe the patients and offer second-line
chemotherapy at disease progression.
Regimens for second-line therapy include docetaxel or pemetrexed monotherapy. Pemetrexed is
less toxic and superior to gemcitabine in non-squamous NSCLC, whereas docetaxel is the
recommended second-line therapy in squamous cell carcinoma.
The results of the studies of maintenance pemetrexed therapy are encouraging; the observed
survival benefit is clinically relevant and relatively large considering the poor survival in
patients with advanced NSCLC. Furthermore, pemetrexed appears to be well tolerated. There
are, however, several limitations to the studies that have been conducted: Relatively few
elderly patients and no PS 2 patients were enrolled - and not all patients on the
control-arms received pemetrexed at progression.
The overall aim of this study is to investigate whether immediate maintenance pemetrexed
therapy prolongs survival compared to observation and pemetrexed therapy at progression in
patients with advanced NSCLC. Furthermore, it will be explored whether patients with
'performance status' 2 and elderly ≥ 70 years tolerate and benefit from maintenance therapy;
and what characteristics and blood biomarkers are associated with sensitivity and
tolerability of such therapy.
Status | Terminated |
Enrollment | 230 |
Est. completion date | March 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Measureable disease according to the RECIST 1.1 - Previous radiotherapy is acceptable provided there are measurable, previously not irradiated lesions present - Histologically or cytologically confirmed non-squamous non-small cell lung cancer - Stage IIIB ineligible for curative therapy or stage IV disease - ECOG Performance 0-2 - Adequate organ function defined as: 1. 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. 2. Total serum bilirubin = 1.5 x ULN 3. Absolute neutrophil count (ANC) = 1.5 x 109/L 4. Platelets = 100 x 109/L 5. Creatinine clearance > 45 ml/min - Able to discontinue NSAIDs and ASA if reduced renal function - All fertile patients should use safe contraception - Written informed consent Exclusion Criteria: - 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. - activating EGFR-mutation or ALK-translocation detected - 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 - conditions - medical, social, psychological - which could prevent adequate information and follow-up - clinically active cancer other than NSCLC - known hypersensitivity or contraindications for the study drugs (vinorelbine, carboplatin, pemetrexed, B12, folate) - pregnant or lactating women |
Country | Name | City | State |
---|---|---|---|
Norway | St Olavs Hospital | Trondheim |
Lead Sponsor | Collaborator |
---|---|
Norwegian University of Science and Technology | St. Olavs Hospital |
Norway,
Halvorsen TO, Stokke K, Killingberg KT, Raj SX, Sørhaug S, Brustugun OT, Fløtten Ø, Helbekkmo N, Hornslien K, Madebo T, Fluge S, Grønberg BH. Randomized phase III trial comparing switch-maintenance pemetrexed with observation followed by pemetrexed at pro — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Overall survival in elderly and PS 2 patients | All patients will be followed until death of any reason - assessed up to 24 months after inclusion in the study. | 2 years | |
Other | Associations between clinical characteristics and blood biomarkers - and outcomes of therapy | All patients will be followed until death of any reason - assessed up to 24 months after inclusion in the study. | 2 years | |
Other | Toxicity in elderly and PS 2 patients | All patients will be followed for 2 years (or until 1 month after the end of study therapy if study therapy is discontinued before 2 years after study inclusion). | 2 years | |
Other | Health related quality of life in elderly and PS 2 patients | All patients will be followed until discontinuation of study therapy - up to 24 months after inclusion in the study. | 2 years | |
Primary | overall survival | All patients will be followed until death of any reason - assessed up to 24 months after inclusion in the study. | 2 years | |
Secondary | progression free survival | From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months. | 2 years | |
Secondary | Toxicity | All patients will be followed for 2 years (or until 1 month after the end of study therapy if study therapy is discontinued before 2 years after study inclusion). | 2 years | |
Secondary | Health related quality of life | All patients will be followed until discontinuation of study therapy - up to 24 months after inclusion in the study. | 2 years |
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