UNIVERSITY HOSPITAL BASEL: SAKK 16/14 – Anti-PD-L1 antibody MEDI4736 in addition to neoadjuvant chemotherapy in non-small cell lung cancer (NSCLC) patients with mediastinal lymph node metastases (stage IIIA(N2))

 

Year of Grant: 2015

Location: Switzerland

 

Lung cancer is one the most frequent malignant tumor. Of the estimated 7.4 million males diagnosed with cancer worldwide in 2012, lung cancer was the most common, accounting for almost a fifth (17%) of all cases diagnosed. Non-small cell lung cancer (NSCLC) accounts for 80% of all lung cancer cases. About a quarter of patients are diagnosed with locally advanced stage disease with involvement of lymph nodes in the lung hilus or the mediastinum (UICC stage IIIA). This stage is amendable to a curative treatment approach.

 

The research group has previously established the use of preoperative chemotherapy (3 cycles of cisplatin and docetaxel) followed by tumor resection as standard of care for this patient population. However, more than 50% of patients experience tumor progression or relapse within one year after this intense therapy.

 

Based on results from previous trials by the group and the recent promising results of cancer immunotherapy in the treatment of advanced and metastatic NSCLC, this new clinical trial seeks to further investigate and substantially improve the prognosis of NSCLC patients with stage IIIA combing pre- and post-operative immune checkpoint inhibition with the anti-PD-L1 antibody MEDI4736.

 

Sixty-eight (68) patients will be treated in this study. The primary endpoint of this trial is event-free survival (EFS) at 12 months, with the intention to show promising efficacy results of the tested therapeutic intervention compared to the historical data from previous trials, which are in a similar range and can be used as comparator for the current single arm phase II study. This knowledge is required to optimally implement these new agents, so that lung cancer patients benefitting from this therapeutic option can clearly be identified.

 

NOTE: This project is the top scoring proposal for the 2015 SAKK/RTFCCR/Gateway Research Grant addressing critical challenge #1: Increase the efficacy of cancer diagnostics and therapeutics through targeted and personalized medicine.