A Phase 3 interventional study of maintenance pemetrexed and pemetrexed at progression in Carcinoma, Non-small-cell Lung, sponsored by Norwegian University of Science and Technology. Terminated at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-23.
Sponsored by Norwegian University of Science and Technology · Phase 3, Interventional, and Treatment
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.
In previous studies without maintenance therapy, median overall survival (OS) for performance status (PS) 0-1 patients has been approximately 9 months, corresponding to 6 months from randomization in this study. We consider an improvement in overall survival of two months to be the minimum difference that will lead to routine use of maintenance pemetrexed in Norway. To demonstrate an improvement in median overall survival from 6 to 8 months with an α =0.05 and β =0.20, 198 evaluable patients are required on each arm. We expect a drop-out rate of maximum 10 %, and therefore intend to randomize a total of 436 patients (PS 0-1) - of which we expect 150 to be 70 years or older.
Sample size is calculated on PS 0-1 patients only. In addition, PS 2 patients will be randomized until the required number of PS 0-1 patients have been accrued. We estimate that a total of 100 PS 2 patients will be enrolled - sufficient for hypothesis-generating analyses of the benefit of maintenance therapy in elderly and PS 2 patients.
Based on experience from our previous studies we estimate that approximately 30% of patients will not complete or progress during induction chemotherapy; or be ineligible due deterioration of PS. Consequently, we need to include approximately 765 patients.
6,485 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.
This study's enrollment of 230 is above the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Norwegian University of Science and Technology is the lead sponsor of 486 studies on the registry; 52 are open to participants now.
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Adequate organ function defined as:
Exclusion Criteria:
maintenance pemetrexed immediately after induction chemotherapy
Drug: maintenance pemetrexed
observation and pemetrexed therapy at disease progression
Drug: pemetrexed at progression
500 mg/m2 Body Surface Area is administered intravenously every 3 weeks
Also known as: Alimta
500 mg/m2 Body Surface Area is administered intravenously every 3 weeks
Also known as: Alimta
overall survival
All patients will be followed until death of any reason - assessed up to 24 months after inclusion in the study.
Time frame: 2 years
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.
Time frame: 2 years
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).
Time frame: 2 years
Health related quality of life
All patients will be followed until discontinuation of study therapy - up to 24 months after inclusion in the study.
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2 years
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).
Time frame: 2 years
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.
Time frame: 2 years
This study is terminated, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Norwegian University of Science and Technology