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 subjects with non-small cell lung cancer (NSCLC) previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy (CACZ885V2301, CANOPY-2)
- Conditions
- Lungcancernon-small cell lung cancer1003866610029107
- Registration Number
- NL-OMON49205
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
* Males or females * 18 years of age.
* Histologically confirmed locally advanced stage IIIB or IV NSCLC.
* One prior platinum-based chemotherapy and one prior PD-(L)1 inhibitor therapy
for locally advanced or metastatic disease, see protocol paragraph 5.1 item 4
for details.
* ECOG performance status (PS) of 0 or 1.
* At least 1 measurable lesion by RECIST 1.1.
* Adequate organ function, see protocol paragraph 5.1 item 8 for details
* Written informed consent
* Previous treatment with docetaxel, canakinumab or other IL-1* inhibitor or
another 1st line treatment than chemotherapy plus PD(L)1 inhibitor.
* EGFR sensitizing mutations, see protocol paragraph 5.2 item 2 for details.
* Previously untreated or symptomatic central nervous system (CNS) metastases
or lepto- meningeal disease, see protocol paragraph 5.2 item 7 for details.
* Suspected or proven immunocompromised state or infections, see protocol
paragraph 5.2 item 6 for details.
* Live vaccination within 3 months prior to first dose of study drug.
* Pregnant or lactating women, females of childbearing potential and males not
using adequate contraception. See protocol paragraph 5.2 item 19-21 for
details.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part 1: RP3R.<br /><br>Part 2: OS.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Part 1: pharmacokinetic parameters, adverse events, anti-drug antibodies of<br /><br>canakinumab and pembrolizumab, ORR, DCR and DOR.<br /><br>Part 2: PFS, ORR, DCR, TTR and DOR, adverse events, pharmacokinetic parameters,<br /><br>anti-drug antibodies against canakinumab, ECOG score, questionnaires QLQ-C30,<br /><br>QLQ-LC13 EQ-5D-5L.</p><br>