Efficacy and Safety of Combination Therapy With Bojungikki-tang and Pembrolizumab Monotherapy in Patients With Advanced Non-small Cell Lung Cancer

This is a multicenter, open-label, randomized controlled clinical trial designed to evaluate the efficacy and safety of combination therapy with Bojungikki-tang(BJIKT) and pembrolizumab monotherapy in patients with advanced non-small cell lung cancer whose tumors express PD-L1 positive with no EGFR or ALK genomic tumor aberrations. Based on prior pre-clinical studies, the combination of Bojungikki-tang and immune checkpoint inhibitors (ICIs) can be expected to improve survival and enhance the therapeutic efficacy of ICIs by modulating the systemic tumor-immune environment. Therefore, this cl

Trial Details

NCT ID
NCT06249854
Phase
PHASE2
Sponsor
Korea Institute of Oriental Medicine
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Bojungikki-tang(BJIKT)
  • Pembrolizumab
Locations (sample)
  • Anyang-si, Gyeonggi-do, South Korea|37.3925,126.92694
  • Yangsan, Gyeongsangnam-do, South Korea|35.34199,129.03358
  • Seoul, South Korea|37.566,126.9784
  • Seoul, South Korea|37.566,126.9784
  • Seoul, South Korea|37.566,126.9784

Key Eligibility Criteria

  • Patients who voluntarily decided to participate and provided written consent, after listening and understanding the detailed explanation about the …
  • Adult male or female aged 19 years or older
  • Patients with histologically or cytologically confirmed advanced (stage IV) non-small cell lung cancer \[according to TNM 8th edition\] In case of …
  • Patients planned for immune checkpoint inhibitor (Pembrolizumab) monotherapy as first-line treatment (Patients with PD-L1 tumor proportion score(TP…

For full eligibility, visit ClinicalTrials.gov.

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