Comparator supply for NCT05048797
A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations
Sponsor: AstraZeneca (INDUSTRY). Phase: PHASE3. Status: Active Not Recruiting. Countries: United States, Austria, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hong Kong, India, Italy, Japan, Mexico, Netherlands, Poland, South Korea, Spain, Taiwan, Turkey (Türkiye). Last update posted 2026-10-21.
Registry record: https://clinicaltrials.gov/study/NCT05048797.
Canadian-labelled carboplatin
3 marketed Canadian product(s) from 3 manufacturer(s) contain carboplatin. Available strengths: 10 MG. Because the comparator is registered in Canada, supply can be arranged without a Special Access request and with the Canadian label, package insert and lot documentation the protocol expects.
Canadian-labelled cisplatin
4 marketed Canadian product(s) from 4 manufacturer(s) contain cisplatin. Available strengths: 1 MG, 1.0 MG. Because the comparator is registered in Canada, supply can be arranged without a Special Access request and with the Canadian label, package insert and lot documentation the protocol expects.
Canadian-labelled pembrolizumab
2 marketed Canadian product(s) from 1 manufacturer(s) contain pembrolizumab. Available strengths: 165 MG, 25 MG. Because the comparator is registered in Canada, supply can be arranged without a Special Access request and with the Canadian label, package insert and lot documentation the protocol expects.
Canadian-labelled pemetrexed
11 marketed Canadian product(s) from 5 manufacturer(s) contain pemetrexed (pemetrexed disodium). Available strengths: 100 MG, 1000 MG, 500 MG. Because the comparator is registered in Canada, supply can be arranged without a Special Access request and with the Canadian label, package insert and lot documentation the protocol expects.
Canadian-labelled trastuzumab deruxtecan
1 marketed Canadian product(s) from 1 manufacturer(s) contain trastuzumab deruxtecan. Available strengths: 100 MG. Because the comparator is registered in Canada, supply can be arranged without a Special Access request and with the Canadian label, package insert and lot documentation the protocol expects.
What we supply
- Canadian-labelled comparator sourced through licensed Canadian supply
- Certificate of Analysis for every batch
- Batch number and expiry documentation, with retained records
- Blinding-ready packaging and over-encapsulation on request
- 2–8 °C validated cold chain with temperature logging where required
- Health Canada Drug Establishment Licence #3-002896
Frequently asked questions
Can Nexara supply Canadian-labelled carboplatin as a trial comparator?
Yes. We source Canadian-marketed carboplatin under Health Canada Drug Establishment Licence #3-002896 and ship it with Certificate of Analysis, batch number and expiry documentation for use as a comparator or rescue supply in NCT05048797.
What documentation comes with each shipment?
Certificate of Analysis, manufacturer batch and expiry records, chain-of-custody documentation from the Canadian supply chain, and temperature records where cold chain applies. Blinding-ready packaging is available on request.
How long does comparator supply take?
Quotes are returned within one business day. Lead time depends on the presentation and the destination country's import route — typically 10 to 21 days once the importer's licence and any notification are in place.
Request comparator quote
Request comparator quote or call +1 (431) 588-9055.