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C. Duval Fraser
P1.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 206)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
P1.01-077 - First-Line Nivolumab + Nab-Paclitaxel + Carboplatin (C) in Advanced NSCLC (ID 1565)
09:30 - 17:00 | Author(s): C. Duval Fraser
Nivolumab, an anti-PD-1 inhibitor, has demonstrated anti-tumor activity in several solid tumors and is approved for unresectable/metastatic melanoma and disease progression following ipilimumab, and if BRAF V600 mutation positive, a BRAF inhibitor; and for metastatic squamous NSCLC in patients with progression on/after platinum-based chemotherapy. Combining a taxane, which can act as a cytotoxic and an immunomodulator, with an immune checkpoint inhibitor has demonstrated improved outcomes over chemotherapy alone in NSCLC. First-line nivolumab and solvent-based paclitaxel plus C (sb-P/C) resulted in a 43% overall response rate and a median progression-free survival of 31 weeks in an interim analyses from a phase I trial in patients with advanced NSCLC (Antonia et al. Presented at ASCO 2014 [Abstract 8113]). nab-Paclitaxel (nab-P) based therapy has demonstrated improved efficacy over standard treatment in pancreatic and breast cancers, and nab-P plus carboplatin (nab-P/C) significantly improved the primary endpoint (ORR) vs sb-P/C in a phase III trial of patients with advanced NSCLC (Socinski et al. J Clin Oncol. 2012;30:2055-2062) and does not requires immunosuppressive premedication. This phase I, open-label, 6-arm, multicenter trial, will evaluate safety of nivolumab with nab-P in 3 cancer types: advanced NSCLC (+ C), advanced pancreatic cancer (± gemcitabine), and metastatic breast cancer; 2 arms in each disease. The study design for the NSCLC portion is described below.
Eligibility criteria include histologically/cytologically confirmed stage IIIB/IV NSCLC, no prior chemotherapy for metastatic disease, prior adjuvant chemotherapy allowed providing completion >12 months before study entry, ECOG PS 0-1, adequate organ function, and preexisting peripheral neuropathy grade <2. NSCLC patients will be treated in 2 arms: 4 cycles of nab-P 100 mg/m on days 1, 8, and 15 plus C AUC 6 on day 1 of a 21 day cycle with nivolumab 5 mg/kg on day 15 starting at cycle 1 or the same nab-P/C regimen with nivolumab 5 mg/kg on day 15 starting at cycle 3. In both arms, nivolumab monotherapy will begin at cycle 5. Part 1 will assess the dose-limiting toxicities (DLTs) of the nivolumab dose with nab-P/C (≈ 6 patients/arm). If deemed safe, the treatment arms may be expanded using the recommended part 2 dose with an additional ≈ 14 patients/arm (total of 20 nivolumab-treated patients/arm) to further assess safety and tolerability as well as anti-tumor activity. Patients will be allowed to continue nivolumab treatment beyond RECIST 1.1 disease progression (physician discretion). ClinicalTrials.gov number NCT02309177. Figure 1 .
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