Trial Profile
A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671)
Status:
Active, no longer recruiting
Phase of Trial:
Phase III
Latest Information Update: 27 Feb 2024
Price :
$35
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At a glance
- Drugs Pembrolizumab (Primary) ; Cisplatin; Gemcitabine; Pemetrexed
- Indications Non-small cell lung cancer; Squamous cell cancer
- Focus Registrational; Therapeutic Use
- Acronyms KEYNOTE-671
- Sponsors Merck Sharp & Dohme Corp.
- 23 Feb 2024 According to a Merck and Co media release, the CHMP's recommendation will now be reviewed by the European Commission for marketing authorization in the European Union (EU), and a final decision is expected in the first half of 2024.
- 23 Feb 2024 According to a Merck and Co media release, based on positive overall survival and event-free survival results, company today announced that European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as a monotherapy as adjuvant treatment, for the treatment of resectable NSCLC at high risk of recurrence in adults.
- 24 Oct 2023 Results of the protocol-specified second interim analysis of KEYNOTE-671 presented at the 48th European Society for Medical Oncology Congress