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Poster Display session 1

3789 - Pioglitazone and clarithromycin combined with metronomic low-dose chemotherapy versus nivolumab in patients with advanced non–small-cell lung cancer treated in 2nd-line and beyond: Outcomes from a randomized phase II trial (ModuLung)

Date

28 Sep 2019

Session

Poster Display session 1

Topics

Tumour Site

Non-Small Cell Lung Cancer

Presenters

Daniel Heudobler

Citation

Annals of Oncology (2019) 30 (suppl_5): v602-v660. 10.1093/annonc/mdz260

Authors

D. Heudobler1, C. Schulz2, J.R. Fischer3, P. Staib4, T. Wehler5, T. Südhoff6, T. Schichtl7, J. Wilke8, J. Hahn1, F. Lüke1, M. Vogelhuber1, S. Klobuch1, T. Pukrop1, W. Herr1, S. Held9, K. Beckers10, G. Bouche11, A. Reichle1

Author affiliations

  • 1 Department Of Internal Medicine Iii, University Hospital Regensburg, 93042 - Regensburg/DE
  • 2 Department Of Internal Medicine Ii, University Hospital Regensburg, 93042 - Regensburg/DE
  • 3 Med Klinik Ii Onkologie, Klinik Loewenstein GmbH, 74245 - Löwenstein/DE
  • 4 Euregio Cancer Center Eschweiler, St. Antonius Hospital Klinik für Hämatologie/Onkologie, 52249 - Eschweiler/DE
  • 5 Hämatologie, Onkologie, Palliativmedizin, Pneumologie, Evangelisches Krankenhaus Hamm gGmbH, 66421 - Hamm/DE
  • 6 Department Hematology And Oncology, Klinikum Passau, 94032 - Passau/DE
  • 7 Onkologie, Medizinische Versorgungszentrum, 92637 - Weiden/DE
  • 8 Oncology And Hematology, Schwerpunktpraxis für Hämatologie und internistische Onkologie, 90766 - Fürth/DE
  • 9 Klinische Forschungs Gmbh, ClinAssess, 51379 - Leverkusen/DE
  • 10 Clinical Research, The Anticancer Fund, 1853 - Strombeek-Bever/BE
  • 11 Clinical Research, The Anticancer Fund, Strombeek-Bever/BE

Resources

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Abstract 3789

Background

The ModuLung trial addresses the medical need for low-toxic therapies in frequently comorbid patients with relapsed or refractory non-small cell lung cancer (NSCLC). We evaluated safety and efficacy of a biomodulatory approach in > =2nd-line, aiming for induction of anakoinosis i.e. communicative reprogramming of dysregulated cellular and intercellular homeostasis.

Methods

Patients with stage IIIB/IV squamous or non-squamous NSCLC and disease progression during or after at least one platinum-based chemotherapy were stratified according to histology, and randomly assigned 1:1 to treosulfan 250 mg twice daily, pioglitazone 45 mg once daily and clarithromycin 250 mg twice daily (experimental arm) or nivolumab 3 mg/kg every 2 weeks (control arm). The primary endpoint was progression-free survival (PFS).

Results

Due to the approval of checkpoint inhibitors in first-line, the study was prematurely closed after randomization of 40 of the 86 initially planned patients. The main efficacy and safety results are presented in the table and show no statistically significant difference between groups. The two-year survival rate achieved in the biomodulatory arm was 10% (95% CI, 1.2 to 31.7) and 5.9% (95% CI, 0.1 to 28.7) in the nivolumab arm. 75% and 53% of the patients proceeded to a further line of therapy, respectively.Table:

1570P

Results
Biomodulatory Arm (n = 20) 35% > 2nd-lineNivolumab Arm (n = 17) 41.2% > 2nd-lineHR & 95% CI or p-value
PFS, median in months1.62.1HR = 1.17; 95% CI, 0.59--2.34
OS, median in months8.26.9HR = 0.86; 95% CI, 0.38-1.96
ORR, n (%)2 (10%)0 (0%)P = 0.49
Grade 3-5 AE, n (%)2 (10%)6 (35%)P = 0.11

Conclusions

Combination of clarithromycin, pioglitazone and metronomic chemotherapy is active in the > =2nd line treatment of NSCLC and warrants further investigations. Nivolumab did not induce any tumor response and was relatively toxic in this population. Novel treatment approaches are urgently needed for patients who previously received platinum-based chemotherapy for advanced squamous and non-squamous NSCLC (Funded by Anticancer Fund, EudraCT number 2014-004095-31).

Clinical trial identification

EudraCT: 2014-004095-31, Start Date: 2015-07-13.

Editorial acknowledgement

Legal entity responsible for the study

Freistaat Bayern respresented by University of Regensburg represented by Kaufmännischer Direktor.

Funding

Anticancer Fund, Brussels, Belgium.

Disclosure

All authors have declared no conflicts of interest.

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