Trials / Unknown
UnknownNCT02852083
A Trial With Metronomic Low-dose Treosulfan, Pioglitazone and Clarithromycin Versus Standard Treatment in NSCLC
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 86 (estimated)
- Sponsor
- University Hospital Regensburg · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase II, multicentre, open-label, randomized, and controlled study, evaluating the efficacy and safety of combined modularized treatment of treosulfan, pioglitazone and clarithromycin in patients with with squamous and non- squamous cell lung cancer, respectively after platin failure.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pioglitazone | Pioglitazone 25 mg once daily, p.o. |
| DRUG | nivolumab | 3 mg per kilogram of body weight every 2 weeks, p.o. (standard treatment) |
| DRUG | Treosulfan | Treosulfan 250 mg twice daily, p.o. |
| DRUG | Clarithromycin | Clarithromycin 250 mg twice daily p.o. |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2019-07-01
- Completion
- 2020-07-01
- First posted
- 2016-08-02
- Last updated
- 2018-01-18
Locations
9 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT02852083. Inclusion in this directory is not an endorsement.