Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/7/2019 |
| Start Date: | January 23, 2019 |
| End Date: | August 19, 2021 |
| Contact: | Novartis Pharmaceuticals |
| Email: | novartis.email@novartis.com |
| Phone: | 1-888-669-6682 |
A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Canakinumab in Combination With Docetaxel Versus Placebo in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancer (NSCLC) Previously Treated With PD-(L)1 Inhibitors and Platinum-based Chemotherapy (CANOPY 2)
This phase III study is designed to evaluate the role of IL-1β inhibition in combination with
docetaxel in subjects with advanced NSCLC previously treated with PD-(L)1 inhibitors and
platinum-based chemotherapy. The randomized III part will be preceded by a safety run-in part
in which the recommended dose of the combination of canakinumab and docetaxel will be
confirmed.
docetaxel in subjects with advanced NSCLC previously treated with PD-(L)1 inhibitors and
platinum-based chemotherapy. The randomized III part will be preceded by a safety run-in part
in which the recommended dose of the combination of canakinumab and docetaxel will be
confirmed.
Key Inclusion Criteria:
- Histologically confirmed advanced (stage IIIB) or metastatic NSCLC.
- Subject has received one prior platinum-based chemotherapy and one prior PD-(L)1
inhibitor therapy for locally advanced or metastatic disease.
- Subject with ECOG performance status (PS) of 0 or 1.
- Subject with at least 1 evaluable (measurable or non-measurable) lesion by RECIST 1.1
in solid tumors criteria.
Key Exclusion Criteria:
- Subject who previously received docetaxel, canakinumab (or another IL-1β inhibitor),
or any systemic therapy for their locally advanced or metastatic NSCLC other than one
platinum-based chemotherapy and one prior PD-(L)1 inhibitor.
- Subject with EGFRor ALK positive tumor.
- History of severe hypersensitivity reaction to monoclonal antibodies, taxanes or
excipients of docetaxel or canakinumab.
Other protocol-defined inclusion/exclusion may apply.
We found this trial at
2
sites
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Loma Linda, California
Principal Investigator: Hamid R. Mirshahidi
Phone: 909-558-8683
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