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A..J. De Langen
Poster Display Session (ID 63)
- Event: ELCC 2017
- Type: Poster Display Session
- Presentations: 1
- Coordinates: 5/07/2017, 12:30 - 13:00, Hall 1
80TiP - A feasibility trial evaluating the addition of nivolumab to standard first-line chemo-radiotherapy in locally advanced stage IIIA/B NSCLC: The ETOP 6-14 NICOLAS trial (ID 455)
12:30 - 13:00 | Author(s): A..J. De Langen
Sequential or concomitant chemo-radiotherapy is the treatment of choice for stage III NSCLC. One attempt to improve the long-term survival is an immunotherapeutic strategy. The monoclonal antibody nivolumab targets and inhibits PD-1, an immune receptor on activated T-cells and responsible for abrogating anti-cancer immune response. The role of immune-checkpoint inhibitors is currently being evaluated in this indication as monotherapy or in combination with chemotherapy as well as after completion of chemo-radiotherapy but it has not yet been assessed in combination with radiotherapy. While anecdotal data of concurrent therapy suggests an acceptable toxicity profile, a formal prospective assessment is required before embarking on trials comparing concurrent versus sequential checkpoint inhibitors and radiotherapy.
NICOLAS is a phase II feasibility trial evaluating the administration of nivolumab concomitantly with standard first-line chemo-radiotherapy for locally advanced stage IIIA/B NSCLC. Additional inclusion criteria include adequate organ function and performance status 0-1. Chemotherapy consists of three cycles of cisplatin plus vinorelbine, etoposide or pemetrexed. Radiotherapy to the chest will be delivered either sequentially to or concurrently with chemotherapy. The initial nivolumab dose is 240 mg Q2W for eight cycles in the sequential, and 360 mg Q3W for four cycles in the concurrent chemo-radiotherapy schedule, followed by 480 mg Q4W for maximum one year for both regimens. A total of 43 patients will be recruited into the trial. The primary endpoint is grade > =3 pneumonitis observed up to 6 months after radiotherapy. The goal is to reject a 6-month pneumonitis-free rate of < =67%, tested at a rate of 85%, with 85% power and 5% one-sided alpha. An interim analysis will be performed after 21 patients have completed a 3-month follow-up on nivolumab treatment. Safety is closely monitored by the ETOP IDMC at their regular meetings every three months. NICOLAS is sponsored by ETOP with financial support of Bristol-Meyers Squibb. Accrual is ongoing and as of January 2017, 18 patients have been enrolled.
Clinical trial identification:
Legal entity responsible for the study:
European Thoracic Oncology Platform (ETOP)
R.A. Stahel: Honoraria as consultant at advisory boards from Abbvie, Astra Zeneca, BMS, Boehringer Ingelheim, Eli Lilly, MSD, Pfizer and Roche and as speaker from Astellas, Astra Zeneca, Lilly, MSD, Novartis and Roche. R.M. Huber: Honoraria as consultant at advisory boards from BMS. All other authors have declared no conflicts of interest.