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Poster display session

4191 - Neo-adjuvant chemo/immunotherapy for the treatment of resectable stage IIIA non small cell lung cancer (NSCLC): a phase II multicenter exploratory study” NADIM trial

Date

09 Sep 2017

Session

Poster display session

Presenters

Virginia Calvo de Juan

Citation

Annals of Oncology (2017) 28 (suppl_5): v453-v456. 10.1093/annonc/mdx381

Authors

V. Calvo de Juan1, A. Insa Molla2, M. Cobo Dols3, B. Massuti Sureda4, G. Lopez-Vivanco5, J. Casal Rubio6, J. de Castro7, M. Majem Tarruella8, R. Bernabe Caro9, J. Gonzalez-Larriba10, I.C. Barneto Aranda11, E. Nadal12, A. Martinez Marti13, N. Vinolas Segarra14, M. Guillot Morales15, D. Vicente Baz16, C. Camps Herrero17, M. Domine Gomez18, D. Rodriguez Abreu19, M. Provencio Pulla1

Author affiliations

  • 1 Medical Oncology, Hospital Puerta de Hierro Majadahonda, 28221 - Majadahonda/ES
  • 2 Medical Oncology, Hospital Clinico Universitario de Valencia, 46010 - Valencia/ES
  • 3 Medical Oncology, Hospital Universitario Carlos Haya, 29010 - Malaga/ES
  • 4 Medical Oncology, Hospital General Universitario de Alicante, 3010 - Alicante/ES
  • 5 Medical Oncology, Hospital Cruces, 48903 - Bizcaia/ES
  • 6 Medical Oncology, Complejo Hospitalario Universitario de Vigo. Alvaro Cunqueiro, Vigo/ES
  • 7 Department Of Translational Oncology, University Hospital, Madrid/ES
  • 8 Medical Oncology, Hospital de la Santa Creu i Sant Pau, 8026 - Barcelona/ES
  • 9 Medical Oncology, Hospital Universitario Virgen del Rocio, 41013 - Sevilla/ES
  • 10 Medical Oncology, Hospital Clinico Universitario San Carlos, 28040 - Madrid/ES
  • 11 Medical Oncology, University Hospital Reina Sofia, 14004 - Cordoba/ES
  • 12 Medical Oncology, Catalan Institute of Oncology, 08907 - L'Hospitalet/ES
  • 13 Medical Oncology, Vall d´Hebron University Hospital/Vall d´Hebron Institute Oncology, 08035 - Barcelona/ES
  • 14 Medical Oncology, Hospital Clinic y Provincial de Barcelona, 8036 - Barcelona/ES
  • 15 Oncology Department, Hospital Universitario Son Espases, 07010 - Palma de Mallorca/ES
  • 16 Medical Oncology, Hospital Universitario Virgen Macarena, 41003 - Sevilla/ES
  • 17 Medical Oncology, Hospital General Universitario Valencia, 46018 - Valencia/ES
  • 18 Medical Oncology, University Hospital "Fundacion Jimenez Diaz", 28040 - Madrid/ES
  • 19 Medical Oncology, Hospital Universitario Gran Canaria, Las Palmas de Gran Canaria/ES
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Resources

Abstract 4191

Background

Lung cancer is the primary cause of cancer mortality in western countries. The cure is unlikely in patients with NSCLC and locally advanced stage who are not surgical candidates, with a 3-year survival rate of 27% in those patients receiving chemotherapy and concomitant radiotherapy. On the contrary, in localized stages (stage I, II, IIIA) with surgical resection and cytostatic therapy, a survival of 5 years of 51% is achieved. Currently, there is no consensus on the best standard treatment: the surgical management of stage IIIA NSCLC remains highly controversial and most patients with stage IIIB disease are generally considered inoperable. Since distant metastases remain the major site of failure, it is likely that more effective cytotoxic or other anti-tumor agents will be required. Chemotherapy stimulates an immune response against tumors, which may facilitate immunotherapy anticancer activity. Evidence of synergy between chemotherapy and immunotherapy was shown in several studies.

Trial design

Phase II, single-arm, open-label multicenter study that assesses feasibility, safety and efficacy of combined neoadjuvant therapy with Nivolumab 360 mg + Paclitaxel 200mg/m2 + Carboplatin AUC 6 Q3W, three cycles, in resectable stage IIIA NSCLC patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg Q2W for 4 months and Nivolumab 480mg Q4W for 8 months. The primary endpoint will be Progression Free Survival at 24 months from diagnosis and to assess the efficacy of the combination. The secondary endpoints will be time to progression and overall survival at 3 years, response rate, toxicity profile of the combination, the down-staging rate and complete resection rate. Also, surgical outcome and complications will be assessed. Perform correlatives studies with the objectives of exploring the expression of other biomarkers, such as PD-L1, in tumor tissue, free DNA and circulating tumor cells in liquid biopsy. Describe whether PD-L1 expression is a predictive biomarker for ORR, describe PFS in PD-L1 + (≥1%) population and report imaging response versus pathological response rate.

Clinical trial identification

EudraCT Number: 2016-003732-20

Legal entity responsible for the study

Spanish Lung Cancer Group

Funding

Bristol-Myers Squibb

Disclosure

All authors have declared no conflicts of interest.

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