A Trial With Metronomic Low-dose Treosulfan, Pioglitazone and Clarithromycin Versus Standard Treatment in NSCLC (ModuLung)
|ClinicalTrials.gov Identifier: NCT02852083|
Recruitment Status : Unknown
Verified January 2018 by Albrecht Reichle, University Hospital Regensburg.
Recruitment status was: Recruiting
First Posted : August 2, 2016
Last Update Posted : January 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Lung Cancer Non-Squamous Cell Lung Cancer Non-Small Cell Lung Cancer||Drug: Pioglitazone Drug: nivolumab Drug: Treosulfan Drug: Clarithromycin||Phase 2|
Patients will be randomized 1:1, and will be stratified according to histology (squamous cell carcinoma vs adenocarcinoma).
86 patients with platin refractory Non-Small Cell Lung Cancer (NSCLC) will be treated either with metronomic low-dose treosulfan, pioglitazone and clarithromycin (experimental arm) or with nivolumab (squamous cell lung cancer and nonsquamous cell lung cancer).
Patients will undergo tumor assessments at baseline and every 6 weeks (approximately every two cycles) thereafter, until progression. Patients without progression after 36 weeks will undergo tumor assessments every 12 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Phase II, Randomized Multi-center Trial of a Combined Modularized Treatment With Metronomic Low-dose Treosulfan, Pioglitazone and Clarithromycin Versus Nivolumab in Patients With Squamous Cell Lung Cancer and Non- Squamous Cell Lung Cancer, Respectively After Platin Failure|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2020|
Experimental: A: Biomodulatory treatment
treosulfan 250 mg p.o. twice daily, pioglitazone 45 mg p.o. once daily, clarithromycin 250 mg p.o. twice daily until progression or no clinical benefit observed, whichever comes first.
Pioglitazone 25 mg once daily, p.o.
Other Name: Actos
Treosulfan 250 mg twice daily, p.o.
Clarithromycin 250 mg twice daily p.o.
Active Comparator: B: Standard Treatment
Nivolumab, 3 mg per kilogram of body weight every 2 weeks until disease progression according to RECIST 1.1 or unacceptable toxicity
3 mg per kilogram of body weight every 2 weeks, p.o. (standard treatment)
Other Name: Opdivo
- Progression Free Survival [ Time Frame: up to 6 months after study completion ]
- Overall Survival [ Time Frame: up to 6 months after study completion ]
- Duration of Response [ Time Frame: up to 6 months after study completion ]
- Number of participants experiencing adverse events related to the study drugs [ Time Frame: up to 6 months after study completion ]Safety and Tolerability assessments will include the incidence, nature, and severity of adverse events and laboratory abnormalities graded per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.0). Laboratory safety assessments will include, but are not limited to, the regular monitoring of hematology and blood chemistry
- Number of participants experiencing a change in cellular secretome analytics in serum [ Time Frame: at screening, at the beginning of each new treatment cycle (each cycle consists of 28 days) and at the end of treatment visit, which will take place within 3 weeks of the last intake of study drug ]To measure the effect on inflammation, angiogenesis and immune response (proteomics, lipidomics) on serum samples
- proportion of patients who report a considerable degree of impairment in a respective dimension, i.e. a score value <50 [ Time Frame: up to 6 months after study completion ]evaluate and compare patient reported outcomes (PROs) of lung cancer symptoms and patient functioning between treatment arms
- proportion of patients who report a considerable degree of impairment in a respective dimension, i.e. a score value <50 [ Time Frame: up to 6 months after study completion ]evaluate and compare health-related quality of life (HRQoL) between treatment arms
- Comparison of participants tumour response according to (Response Evaluation Criteria in Solid Tumors) RECIST criteria version 1.1 and Peroxisome proliferator-activated receptor gamma (PPAR-γ) expression [ Time Frame: Baseline ]tissue microarray for analysis of PPAR-γ expression for each tumour sample will be performed.
- description of change in predictive and prognostic exploratory biomarkers for each participant [ Time Frame: at screening,at the beginning of each treatment cycle (each treatment cycle consists of 28 days), and at the end of treatment visit, which will take place within 3 weeks of the last intake of study drug ]For patients participating in University Clinic Regensburg only: Secretome analytics (proteomics, lipidomics) will be performed to monitor functions of tumor-associated cellular compartments on serum samples. Serum samples are taken at the beginning of each new treatment cycle. epidermal growth factor receptor (EGFR), K-ras, Anaplastic lymphoma kinase (ALK), and Programmed cell death protein 1 (PD-1) will be analyzed.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852083
|Contact: Albrecht Reichle, MDemail@example.com|
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|Weiden, Bavaria, Germany|
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|Weiden, Bavaria, Germany|
|Contact: Gabriele Schulze 09613033123 firstname.lastname@example.org|
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