Brief Title: Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A
The primary purpose of the study was to compare the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages II -IIIA according to the 8th edition of the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) and the subset of IIIB (T\>5cm N2 disease) completely resected (R0) non-small cell lung cancer (NSCLC).
Checked against the public recordLast updated Oct 9, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Novartis Pharmaceuticals
- Interventions being studied
- Drug: Canakinumab; Drug: Placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Key Inclusion Criteria: * Had completely resected (R0) NSCLC AJCC/UICC v. 8 stage IIA-IIIA and IIIB (N2 disease only) OR had NSCLC Stage IIA-IIIA, IIIB (N2 disease only) and were candidates for complete resection surgery. * Cisplatin-based chemotherapy was mandatory for all subjects (Exception: In subjects with stage IIA disease with no nodal involvement, cisplatin-based chemotherapy could be administered if recommended by the treating physician). When required, a minimum of two cycles of cisplatin-based chemotherapy was mandatory, after which additional therapies could be given based upon local clinical practice and/or guidelines. Typically, chemotherapy was initiated within 60 days of surgery. * Radiation therapy was allowed if indicated as per local guidelines or practice. * Had recovered from all toxicities related to prior systemic therapy to grade ≤ 1 (CTCAE v 5.0). Exception to this criterion: subjects with any grade of alopecia and grade 2 or less neuropathy were allowed to enter the study * Had ECOG performance status (PS) of 0 or 1 Key Exclusion Criteria: * Had unresectable or metastatic disease, positive microscopic margins on the pathology report, and/or gross disease remaining at the time of surgery * Had received any neoadjuvant therapy * Had presence or history of a malignant disease, other than the resected NSCLC, that had been diagnosed and/or required therapy within the past 3 years Exceptions to this exclusion included the following: completely resected basal cell and squamous cell skin cancers, completely resected carcinoma in situ of any type and hormonal maintenance for breast and prostate cancer \> 3 years. * Had a history of current diagnosis of cardiac disease * Had uncontrolled diabetes * Had known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C (positive or indeterminate central laboratory results) * Subjects had to be evaluated for tuberculosis as per local treatment guidelines or clinical practice. Subjects with active tuberculosis were not eligible. * Had suspected or proven immunocompromised state as described in the protocol * Had live and attenuated vaccination within 3 months prior to first dose of study drug (e.g. MMR, Yellow Fever, Rotavirus, Smallpox, etc.).
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Highlands Oncology Group .Fayetteville, Arkansas
- Cancer and Blood Specialty ClinicLos Alamitos, California
- University of California at Los AngelesLos Angeles, California
- VA Palo Alto Health Care System CRLX030A2301Palo Alto, California
- Sansum ClinicSanta Barbara, California
- Rocky Mountain Cancer Centers Denver-Mdtn(Bone&MarrowTransp)Longmont, Colorado
- Florida Cancer SpecialistsFort Myers, Florida
- Advanced Medical Specialties Drug Ship - 2Miami, Florida
- Florida Cancer Affiliates of OcalaOcala, Florida
- Florida Cancer Specialists NorthSt. Petersburg, Florida
- Florida Cancer SpecialistsWest Palm Beach, Florida
- Rush University Medical Center RegulatoryChicago, Illinois
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 9, 2024. Always confirm current availability with the study team.