A PHASE III, OPEN-LABEL, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF ATEZOLIZUMAB (ANTI-PD L1 ANTIBODY) COMPARED WITH BEST SUPPORTIVE CARE FOLLOWING ADJUVANT CISPLATIN BASED CHEMOTHERAPY IN PATIENTS WITH COMPLETELY RESECTED STAGE IB-IIIA NON-SMALL CELL LUNG CANCER.
- Conditions
- NSCLCPreviously fully resected Non-small cell lung cancer by surgery10038666
- Registration Number
- NL-OMON54656
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 35
- A representative formalin-fixed paraffin-embedded (FFPE) tumor specimen in
paraffin block (preferred) or 15 (or more) unstained, freshly cut, serial
sections (on slides) from an FFPE resected tumor specimen is required for
participation in this study. This specimen must be accompanied by the
associated pathology report - ECOG performance status of 0 or 1 - Histological
or cytological diagnosis of Stage IB (tumors >= 4 cm)*IIIA (T2*3 N0, T1*3 N1,
T1-3 N2, T4-N0 1) non-small cell lung cancer (NSCLC) - Eligible to receive a
cisplatin-based chemotherapy regimen - For female patients of childbearing
potential and male patients with partners of childbearing potential, agreement
(by patient and/or partner) to use a highly effective form(s) of contraception
during study treatment that results in a low failure rate of < 1% per year
when used consistently and correctly. Female and male patients should continue
contraceptive use for 6 months after the last dose of cisplatin-based
chemotherapy (cisplatin plus vinorelbine, docetaxel, gemcitabine, or
pemetrexed). Female patients treated with atezolizumab should continue
contraception use for 5 months after the last dose. Women must refrain from
donating eggs during this same period.
- Illness or condition that may interfere with a patient's capacity to
understand, follow, and/or comply with study procedures
- Pregnant and lactating women
- Treatment with prior systemic chemotherapy, with the following exceptions:
•Chemotherapy for early stage of malignancy with curative intent, provided that
the last dose received was more than 5 years prior to enrollment, is allowed
•Low-dose chemotherapy for non-malignant conditions is allowed
- Hormonal cancer therapy or radiation therapy as prior cancer treatment within
5 years before enrollment
- Treatment with any other investigational agent with therapeutic intent within
28 days prior to enrollment
- Known sensitivity to any component of the chemotherapy regimen the patient
will be assigned to, or to mannitol
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies,
anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Patients who have had prior anti-CTLA-4 treatment may be enrolled, provided
the following requirements are met:
•Last dose of anti-CTLA-4 at least 6 weeks prior to randomization
•No history of severe immune-mediated adverse effects from anti-CTLA- 4 (NCI
CTCAE Grades 3 and 4)
- Known tumor PD-L1 expression status as determined by an IHC assay from other
clinical studies (e.g., patients whose PD-L1 expression status was determined
during screening for entry into a study with anti-PD-1 or anti-PD-L1 antibodies
but were not eligible are excluded)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy outcome measure<br /><br><br /><br>DFS, defined as the time from randomization to the date of occurrence of any of<br /><br>the following, whichever occurs first:<br /><br>- First recurrence of NSCLC, as determined by the investigator after an<br /><br>integrated assessment of radiographic data, biopsy sample results (if<br /><br>available), and clinical status<br /><br>- Occurrence of new primary NSCLC, as assessed by the investigator<br /><br>- Death from any cause<br /><br><br /><br>This efficacy outcome measure will be assessed in PD-L1-selected subpopulations<br /><br>(defined by the SP142 IHC assay) within the Stage II-IIIA subpopulation, in all<br /><br>randomized patients with Stage II-IIIA NSCLC, and in the ITT population.</p><br>
- Secondary Outcome Measures
Name Time Method