GENENTECH – MO43576 – ATEZOLIZUMAB Sub-cutaneous vs IV in NSCLC
Non-Small Cell Lung Cancer (NSCLC)
DISEASE and STUDY BASICS:
This study will evaluate participant-reported preference and satisfaction for atezolizumab SC (sub-cutaneous) or atezolizumab IV in participants with NSCLC.
This is a Phase II, randomized, multi-center, multinational, open-label, cross-over study in participants with PD-L1 positive NSCLC. Two populations will be included: participants with resected Stage IIB-IIIB (early-stage) NSCLC who have completed adjuvant platinum-based chemotherapy without evidence of disease relapse/recurrence, and chemotherapy-naïve participants with Stage IV NSCLC.
Participants whose tumors have an EGFR mutation or ALK rearrangement will be excluded from enrollment. Participants must have PD-L1 positive NSCLC to be enrolled in the study.
Eligible participants with early-stage NSCLC will have had a complete resection of NSCLC and must be adequately recovered from surgery and adjuvant chemotherapy. Prior to treatment with adjuvant atezolizumab, all participants should have received up to four cycles of adjuvant platinum-based chemotherapy, with no evidence of disease relapse/recurrence.
Participants with Stage IV NSCLC will be eligible to join the study if they have not received prior chemotherapy for advanced NSCLC and satisfy the eligibility criteria.
During the study treatment period, participants will be randomly allocated in a 1:1 ratio to treatment Arm A (atezolizumab SC followed by atezolizumab IV) or treatment Arm B (atezolizumab IV followed by atezolizumab SC).
Atezolizumab will be administered on Day 1 of each 21-day cycle. Participants will receive atezolizumab according to their assigned route of administration (i.e., SC or IV) for the first three treatment cycles. At Cycle 4, participants will cross-over and receive atezolizumab administered according to the alternative route of administration for Cycles 4–6.
The standard of care for fully resected NSCLC is adjuvant platinum-based chemotherapy; however results of this therapy leave a risk for recurrence. Non-surgical patients should be considered for conventional or stereotactic radiotherapy. The 5-year survival rate in resected NSCLC patients is over 70%in Stage I patients but only 25% in Stage IIIA patients. In patients with advanced, distant metastatic disease the 5-year survival rate is 2% - 4%, depending on geographic location.
Platinum-based chemotherapy is the standard of care for previously untreated NSCLC patients who do not have EGFR mutation or ALK rearrangements. Treatment in the first line setting involves either cisplatin or carboplatin and a taxane or pemetrexed, with or without bevacizumab for non-squamous NSCLC, and cisplatin or carboplatin and gemcitabine for squamous NSCLC. However, benefits of platinum based doublets have objective response rates about 15% - 22% and median survival of 7 – 10 months. The addition of immunotherapies has resulted in increasing the overall response rate and have increase the median survival to 16.7 and 20.0 months depending upon the Tumor Proportion Score and PD-L1 expression.
The addition of atezolizumab monotherapy has demonstrated statistically significant and clinically meaningful improvement is survival.
Atezolizumab is a monoclonal antibody that enhances and improves anti-tumor activity of tumor-specific T-cell responses resulting in improved anti-tumor activity. Atezolizumab is being investigated in a variety of malignancies and in both the adjuvant and metastatic settings. It is also being studies as a monotherapy and in combination with chemotherapy, targeted therapy and immunotherapy.
Atezolizumab IV is approved for the treatment of urothelial carcinoma, NSCLC, SCLC, triple-negative breast cancer, hepatocellular carcinoma and melanoma.
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