A Study of SYS6010 Plus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy in Non-small Cell Lung Cancer (NSCLC)

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.

About this trial

The purpose of the study is to compare the efficacy and safety of SYS6010 in combination with anti-PD-(L)-1 monoclonal antibody vs. anti-PD-(L)-1 monoclonal antibody as adjuvant therapy for patients with. with completely resected stage II-IIIB, actionable genomic alterations (AGAs) negative non-small cell lung cancer (NSCLC) who did not achieve a major pathological response (MPR).

Eligibility criteria

Qualifiers

Able to understand and willingness to voluntarily provide written informed consent.

Age 18 to 75 years, males or females.

Histologically confirmed squamous or non-squamous NSCLC.

Ability to provide qualified tumor samples.

Disqualifiers

Participants with a condition requiring further surgical resection, in the investigator's opinion.

Participants with diagnosis of stage IIIB with N3, and stage IIIC, IVA, and IVB NSCLC.

Eligible only for incomplete resection.

Participants with synchronous primary lung cancer or multiple primary malignancies, or a mixed histology of SCLC and NSCLC.

Trial design

Treatments tested in this trial

  • SYS6010
  • Enlonstobart
  • Tislelizumab
  • Toripalimab ±+platinum-based doublet chemotherapy
  • Durvalumab
  • Pembrolizumab
  • Nivolumab

Treatment groups

570 Participants
are divided into 2 treatment groups

Locations

This trial has no locations