1286TiP - Neo-adjuvant chemo/immunotherapy for the treatment of resectable stage IIIA non small cell lung cancer (NSCLC): a phase II multicenter exploratory...

Date 09 September 2017
Event ESMO 2017 Congress
Session Poster display session
Topics Anti-Cancer Agents & Biologic Therapy
Cancer in Adolescents
Non-Small-Cell Lung Cancer, Early Stage
Cancer Immunology and Immunotherapy
Lung and other Thoracic Tumours
Presenter 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
  • 1Medical Oncology, Hospital Puerta de Hierro Majadahonda, 28221 - Majadahonda/ES
  • 2Medical Oncology, Hospital Clinico Universitario de Valencia, 46010 - Valencia/ES
  • 3Medical Oncology, Hospital Universitario Carlos Haya, 29010 - Malaga/ES
  • 4Medical Oncology, Hospital General Universitario de Alicante, 3010 - Alicante/ES
  • 5Medical Oncology, Hospital Cruces, 48903 - Bizcaia/ES
  • 6Medical Oncology, Complejo Hospitalario Universitario de Vigo. Alvaro Cunqueiro, Vigo/ES
  • 7Department Of Translational Oncology, University Hospital, Madrid/ES
  • 8Medical Oncology, Hospital de la Santa Creu i Sant Pau, 8026 - Barcelona/ES
  • 9Medical Oncology, Hospital Universitario Virgen del Rocio, 41013 - Sevilla/ES
  • 10Medical Oncology, Hospital Clinico Universitario San Carlos, 28040 - Madrid/ES
  • 11Medical Oncology, University Hospital Reina Sofia, 14004 - Cordoba/ES
  • 12Medical Oncology, Catalan Institute of Oncology, 08907 - L'Hospitalet/ES
  • 13Medical Oncology, Vall d´Hebron University Hospital/Vall d´Hebron Institute Oncology, 08035 - Barcelona/ES
  • 14Medical Oncology, Hospital Clinic y Provincial de Barcelona, 8036 - Barcelona/ES
  • 15Oncology Department, Hospital Universitario Son Espases, 07010 - Palma de Mallorca/ES
  • 16Medical Oncology, Hospital Universitario Virgen Macarena, 41003 - Sevilla/ES
  • 17Medical Oncology, Hospital General Universitario Valencia, 46018 - Valencia/ES
  • 18Medical Oncology, University Hospital "Fundacion Jimenez Diaz", 28040 - Madrid/ES
  • 19Medical Oncology, Hospital Universitario Gran Canaria, Las Palmas de Gran Canaria/ES

Abstract

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.