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T. Tamura
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P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.01-080 - An Open-Label, Multicenter, Phase 1b/2 Study to Evaluate Necitumumab in Combination with Gemcitabine and Cisplatin in the First-Line Treatment of Patients with Advanced (Stage IV) Squamous Non-Small Cell Lung Cancer (NSCLC) (ID 184)
09:30 - 09:30 | Author(s): T. Tamura
- Abstract
Background:
Necitumumab (N) is a human IgG1 anti-epidermal growth factor receptor (EGFR) monoclonal antibody. Squamous (SQ) histology accounts for 25-30% of non-small cell lung cancer (NSCLC) and gemcitabine combined with cisplatin (GC) is a standard of care for advanced or metastatic SQ-NSCLC. In the previous global randomized, open-label, Phase 3 trial (SQUIRE), compared with GC, the addition of N to GC (GC+N) significantly improved overall survival (OS) (HR=0.84, p=0.012; median 11.5 vs 9.9 months) and progression-free survival (PFS) (HR=0.85, p=0.020; median 5.7 vs 5.5 months). The objective response rate (ORR) was 31% vs 29% (p=0.400), and the disease control rate (DCR) was 82% vs 77% (p=0.043), respectively. The SQUIRE results were an important advance in the search for a new treatment for patients with metastatic SQ-NSCLC, where limited progress has been made over the last two decades. However, only 8% of patients in SQUIRE Trial were Asian and no Japanese institutions participated. We have therefore conducted this Phase 1b/2 trial to evaluate the efficacy and safety of GC+N in Japanese patients with advanced SQ-NSCLC.
Methods:
This trial consists of a Phase 1b and Phase 2 part. Patients with advanced (Stage IV) SQ-NSCLC are eligible for enrollment if they are aged³20 years with an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1; measurable or nonmeasurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0; adequate organ function. GC+N or GC may continue for a maximum of 4 cycles; patients with at least stable disease in GC+N may continue to receive N until disease progression or emerging non-acceptable toxicity. The purpose of Phase 1b part is to determine the recommended dose of the combination of GC (G=1000 or 1250 mg/m[2] iv, Days 1 and 8; C=75 mg/m[2] iv, Day 1; 3-week cycle) and N (800 mg iv, Days 1 and 8; 3-week cycle). Patients are enrolled in 2 cohorts using a conventional 3+3 study design, with dose-escalation of gemcitabine permitted according to the incidence of dose-limiting toxicity (DLT). The Phase 2 part is an open-label, randomized trial to evaluate the efficacy and safety of addition of N to GC. Patients are randomly assigned on a 1:1 basis (Stratification factors: ECOG PS and gender) to GC+N (Arm A) or GC (Arm B). The primary endpoint is OS for which the final analysis will be performed when at least 137 events are observed. The sample size of 180 patients (137 events) has 68% power for a log-rank test at 0.2 one-sided alpha. The secondary endpoints include PFS, ORR, time to treatment failure, Pharmacokinetics, safety and patient-reported outcomes. The relationship between EGFR protein expression level by immunohistochemistry (IHC) and each of several efficacy measures will also be assessed. Translational research analyses will be performed to analyze relevant biomarkers for clinical outcomes. ClinicalTrial.gov Identifier: NCT01763788.
Results:
Not applicable
Conclusion:
Not applicable
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P3.07 - Poster Session/ Small Cell Lung Cancer (ID 223)
- Event: WCLC 2015
- Type: Poster
- Track: Small Cell Lung Cancer
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.07-005 - Maintenance Irinotecan Therapy in Extensive Disease Small Cell Lung Cancer: A Feasibility Study (ID 607)
09:30 - 09:30 | Author(s): T. Tamura
- Abstract
Background:
We performed a feasibility study of maintenance irinotecan therapy in patients with extensive disease small cell lung cancer (ED-SCLC) who responded to the induction irinotecan plus cisplatin (IP) therapy.
Methods:
The eligibility criteria included pts with ED-SCLC who responded to four cycles of induction IP therapy, ECOG performance status (PS) of 0 to 1, age of 20 to 70 years and adequate organ functions. Pts received irinotecan monotherapy at 60 mg/m2 on days 1, 8 and 15 of a 28-day cycles until disease progression. The primary endpoint was the proportion of treatment success (TS) at 6 months. Using a binomial design, a lower activity level (p0) of 0.25 and a target activity level (p1) of 0.50, the preplanned accrual of 28 patients was sufficient (alpha, 0.10 and power, 0.90).
Results:
Between August 2012 and August 2013, 22 pts were enrolled. However, accrual was discontinued because of the three grade 3 pneumonitis events (3 of 22 patients, 13.6%). Patient characteristics of the 22 eligible pts were as follows; the median age was 65 (54-70) years; 12 pts had a PS of 0, and 16 pts were male. The median number of cycles delivered was four (range, 1–31). Four of 22 (18.2%) patients achieved TS at 6 months. Median progression free survival and overall survival from the start of the maintenance irinotecan therapy were 3.2 months and 15.9 months, respectively. Grade ≥3 toxicities included neutropenia (4.5%), hyponatremia (4.5%), pneumonitis (13.6%) and cholangitis (4.5%). No treatment-related deaths occurred. Figure 1
Conclusion:
This trial was early terminated due to the unexpected toxicity, but maintenance irinotecan therapy was still active for a subset of ED-SCLC.
