Squamous Cell Lung CancerPhase 2ModuLungNCT02852083
A Trial With Metronomic Low-dose Treosulfan, Pioglitazone and Clarithromycin Versus Standard Treatment in NSCLC
A Phase 2 study testing Pioglitazone, nivolumab and Treosulfan in people with Squamous Cell Lung Cancer and Non-Squamous Cell Lung Cancer, run by University Hospital Regensburg at 9 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Lung Cancer, Non-Squamous Cell Lung Cancer, Non-Small Cell Lung Cancer
- What is being tested?
- Pioglitazone, nivolumab and Treosulfan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 9 sitesGermany
- Study dates
- Jan 2016to Jul 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form
- Ability to comply with protocol
- Age ≥ 18 years
- Measurable disease, as defined by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy ≥ 12 weeks
Show all 19Show fewer
- Histologically or cytologically confirmed locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC (per the Union Internationale Contre le Cancer/American Joint Committee on Cancer [UICC/AJCC] staging system);
- Disease progression during or following treatment with a prior platinum containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum based adjuvant/neoadjuvant regimen
- No more than 2 cytotoxic chemotherapy regimens
- Patients that have progressed during or after treatment with EGFR Tyrosine Kinase Inhibitor (TKI) in first line, or are intolerant to treatment with erlotinib, gefitinib, or another EGFR TKI may be included.
- Patients that have progressed during or after , or intolerant to treatment with crizotinib or another ALK inhibitor
- The last dose of prior systemic anti-cancer therapy must have been administered ≥ 21 days prior to randomization (≥ 14 days for vinorelbine or other vinca alkaloids or gemcitabine.)
- The last dose of treatment with any investigational agent must have ended ≥ 28 days prior to randomization.
- Prior radiation therapy is allowed provided recovery from any toxic effects thereof and ≥ 7 days between the last fraction and randomization.
- Adequate hematologic and end organ function, defined by the following (max 14 days prior study treatment): Absolute Neutrophil Count (ANC) ≥ 1500 cells/μL (without granulocyte colonystimulating factor support within 2 weeks of sampling), White Blood Cell (WBC) counts > 2,500/μL and < 15,000/μL, lymphocyte count ≥ 500/μL, Platelet count ≥ 100,000/μL (without transfusion within 2 weeks of sampling), Hemoglobin ≥ 9.0 g/dL. Transfusion or erythropoietic treatment is allowed.
- Liver function tests meeting one of the following criteria: Aspartate Transaminase (AST) or Alanine Transaminase (ALT) ≤ 2.5 × ULN, with normal alkaline phosphatase or AST and ALT ≤ 1.5 × ULN in conjunction with alkaline phosphatase > 2.5 × ULN; Serum bilirubin ≤ 1.0 × ULN. Patients with known Gilbert's disease must have serum bilirubin level ≤ 3 × ULN.
- Prothrombin Time - International Normalized Ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN, without anticoagulants. Patients receiving therapeutic anticoagulation must be on a stable dose for at least 1 week prior to randomization.
- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form of contraception (e.g., surgical sterilization, a reliable barrier method, birth control pills, or contraceptive hormone implants) and to continue its use for 6 months after the last dose of the combined modularized treatment.
- Patients must have recovered from all acute toxicities from previous therapy, excluding alopecia.
Who cannot join
- Cancer-Specific Exclusion Criteria
- Known active or untreated central nervous system (CNS) metastases.Patients with a history of treated asymptomatic CNS metastases are eligible, if they meet all of the following criteria: No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus. Radiographic demonstration of improvement upon the completion of CNS directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study
- History of intracranial hemorrhage
- Ongoing requirement for dexamethasone for CNS disease
- Stereotactic radiation or whole-brain radiation within 28 days prior to Cycle 1,Day 1
- Screening CNS imaging ≥ 4 weeks since completion of radiotherapy and ≥ 2 weeks since discontinuation of corticosteroids
Show all 35Show fewer
- Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression that has not been clinically stable for ≥ 2 weeks prior to randomization
- Leptomeningeal disease
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Uncontrolled tumor-related pain: patients requiring pain medication must be on a stable regimen at study entry. Symptomatic lesions amenable to palliative radiotherapy should be treated prior to enrolment. Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain should be considered for loco-regional therapy prior to enrolment.
- Hypercalcemia (Ca > 1.5 mmol/L ionized calcium or Ca > 12 mg/dL or corrected serum calcium > ULN) or symptomatic hypercalcemia requiring continuous bisphosphonate therapy or denosumab. Patients who are receiving bisphosphonate therapy or denosumab specifically to prevent skeletal events and without a history of clinically significant hypercalcemia are eligible.
- Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with curative outcome
- General Exclusion Criteria
- History of idiopathic pulmonary fibrosis (including pneumonitis), history of drug-induced pneumonitis
- Serum albumin < 2.5 g/dL
- Patients with active hepatitis B or hepatitis C. Patients with past Hepatitis B Virus (HBV) infection or resolved HBV are eligible. Patients positive for Hepatitis C Virus (HCV) antibody are eligible only if Polymerase Chain Reaction (PCR) is negative for HCV Ribonucleic Acid (RNA).
- Significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease
- Significant cardiovascular disease, such as myocardial infarction within 3 months prior to randomization, unstable arrhythmias, or unstable angina.
- Known left ventricular ejection fraction (LVEF) < 40%. Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or LVEF < 50% must be on a stable medical regimen.
- Tuberculosis
- Severe infections within 4 weeks prior to randomization
- oral or intravenous antibiotics within 2 weeks prior to randomization
- Major surgical procedure within 4 weeks prior to randomization or expected need for a major surgical procedure during the course of the study other than for diagnosis
- Prior treatment with nivolumab
- Grade ≥ 2 peripheral neuropathy as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTC AE) v4.0 criteria
- Patients undergoing dialysis or creatinine clearance <30 mL per minute,defined according to Modification of Diet in Renal Disease Study Criteria (MDRD)
- Patients with uncontrolled hypertension (Respiratory rate continuously > 140/90 mm Hg)
- Simultaneous treatment with another investigational agent or simultaneous anticancer treatment outside this trial
- Heart failure > New York Heart Association (NYHA) 1, QT prolongation, ventricular arrhythmias, torsade de pointes
- Creatinine > 1.5 mg/dL
- chronic hypopotassemia
- HIV infection requiring virostatic therapy
- past or current bladder cancer , patients with risk factors for bladder cancer (such as exposure to aromatic amines or heavy tobacco smokers), or macrohematuria of unknown origin
- Known gastrointestinal disorder, including malabsorption or active gastric ulcer, that might interfere with oral intake and absorption of study medication
- Autoimmune disease, symptomatic interstitial lung disease, systemic immunosuppression, prior therapy with T-cell costimulation or checkpoint targeted agent
Trial locations and contacts
9 sites in 1 country.
Albrecht Reichle, MD contact
9 sites in 1 country
Germany9 sites, 9 recruiting
- Recruiting
St. Antonius-Hospital
Eschweiler, North Rhine-Westphalia
Susanne Recker, 02403761737, studiensekretariat.onkologie@sah-eschweiler.de
- Recruiting
Onkologische Gemeinschaftspraxis Dres. Wilke/ Wagner/Petzoldt
Fürth, Bavaria
Traudl Gietl-Drescher, 09119792220, info@onkologie-fuerth.de
- Recruiting
Krankenhaus Martha-Maria
Halle, Saxony-Anhalt
Sabine Leysring, 03455591434, studiensekretariat.schuette@nicsys.de
- Recruiting
Klinik für Innere Medizin
Homburg/Saar, Saarland
Thomas Wehler, Thomas.Wehler@uks.eu
- Recruiting
Klinikum Kempten Oberallgäu
Immenstadt im Allgäu, Bavaria
Simone Eberl, 08323-9108968, pneumologie.studien@kv-keoa.de
- Recruiting
MVZ am Klinikum GmbH
Passau, Bavaria
Margit Schicht, 085153002299, studiensekretariat@klinikum-passau.de
- Recruiting
Universitätsklinikum Regensburg
Regensburg, Bavaria
Albrecht Reichle, MD, albrecht.reichle@klinik.uni-regensburg.de
- Recruiting
Kliniken Nordoberpfalz AG, Klinikum
Weiden, Bavaria
Gabriele Schulz
Karola Dorner
- Recruiting
MVZ Weiden GmbH
Weiden, Bavaria
Gabriele Schulze, 09613033123, gabriele.schulze@kliniken-nordoberpfalz.ag
Karola Dorner, 09613033258, karola.dorner@kliniken-nordoberpfalz.ag
About this study
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
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.
Read the 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.
- Being tested
- Pioglitazone, nivolumab, Treosulfan, Clarithromycin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
Also called Actos
Pioglitazone 25 mg once daily, p.o.
nivolumabDrug
Also called Opdivo
3 mg per kilogram of body weight every 2 weeks, p.o. (standard treatment)
TreosulfanDrug
Treosulfan 250 mg twice daily, p.o.
ClarithromycinDrug
Clarithromycin 250 mg twice daily p.o.
| Study group | Role | What they receive |
|---|---|---|
| A: Biomodulatory treatment | Experimental | 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. Receives: Drug: Pioglitazone; Drug: Treosulfan; Drug: Clarithromycin |
| B: Standard Treatment | Active comparator | Nivolumab, 3 mg per kilogram of body weight every 2 weeks until disease progression according to RECIST 1.1 or unacceptable toxicity Receives: Drug: nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: up to 6 months after study completion
Secondary outcomes (8)
Overall Survival
Measured: up to 6 months after study completion
Duration of Response
Measured: up to 6 months after study completion
Number of participants experiencing adverse events related to the study drugs
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
Measured: up to 6 months after study completion
Number of participants experiencing a change in cellular secretome analytics in serum
To measure the effect on inflammation, angiogenesis and immune response (proteomics, lipidomics) on serum samples
Measured: 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
proportion of patients who report a considerable degree of impairment in a respective dimension, i.e. a score value <50
evaluate and compare patient reported outcomes (PROs) of lung cancer symptoms and patient functioning between treatment arms
Measured: up to 6 months after study completion
proportion of patients who report a considerable degree of impairment in a respective dimension, i.e. a score value <50
evaluate and compare health-related quality of life (HRQoL) between treatment arms
Measured: up to 6 months after study completion
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
tissue microarray for analysis of PPAR-γ expression for each tumour sample will be performed.
Measured: Baseline
description of change in predictive and prognostic exploratory biomarkers for each participant
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2019 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Regensburg
- Sponsor type
- University, hospital or other
- Collaborators
- The Anticancer Fund
- Responsible party
- Principal investigator, Albrecht Reichle, University Hospital Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852083
- Sponsor's protocol ID
- ModuLung
- Acronym
- ModuLung
- Status last verified
- Jan 2018
- First submitted
- 12 Jul 2016
- Last updated
- 18 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02852083
- Acronym / sponsor ID
- ModuLung / ModuLung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- University Hospital RegensburgUniversity, hospital or other
- Collaborators
- The Anticancer Fund
- Study start
- Jan 2016
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Biomodulatory treatment | Experimental | Drug: Pioglitazone, Drug: Treosulfan, Drug: Clarithromycintreosulfan 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. |
| B: Standard Treatment | Active comparator | Drug: nivolumabNivolumab, 3 mg per kilogram of body weight every 2 weeks until disease progression according to RECIST 1.1 or unacceptable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Signed Informed Consent Form
- Ability to comply with protocol
- Age ≥ 18 years
- Measurable disease, as defined by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (35 listed)
- Cancer-Specific Exclusion Criteria
- Known active or untreated central nervous system (CNS) metastases.Patients with a history of treated asymptomatic CNS metastases are eligible, if they meet all of the following criteria: No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus. Radiographic demonstration of improvement upon the completion of CNS directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study
- History of intracranial hemorrhage
- Ongoing requirement for dexamethasone for CNS disease
- Stereotactic radiation or whole-brain radiation within 28 days prior to Cycle 1,Day 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PioglitazoneAlso: ActosPioglitazone 25 mg once daily, p.o. | Drug | A: Biomodulatory treatment |
| nivolumabAlso: Opdivo3 mg per kilogram of body weight every 2 weeks, p.o. (standard treatment) | Drug | B: Standard Treatment |
| TreosulfanTreosulfan 250 mg twice daily, p.o. | Drug | A: Biomodulatory treatment |
| ClarithromycinClarithromycin 250 mg twice daily p.o. | Drug | A: Biomodulatory treatment |
Primary outcome
Progression Free Survival
Time frame: up to 6 months after study completion
8 secondary outcomes
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albrecht Reichle, MD contact
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pioglitazone, nivolumab and Treosulfan in people with Squamous Cell Lung Cancer and Non-Squamous Cell Lung Cancer, run by University Hospital Regensburg at 9 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Albrecht Reichle, MD (albrecht.reichle@klinik.uni-regensburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: up to 6 months after study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.