NCT07672223Not yet recruitingPhase 3
A Study of SYS6010 Plus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy in Non-small Cell Lung Cancer (NSCLC)
A Phase III, Randomized, Open-Label Study of SYS6010 in Combination With Anti-PD-(L)-1 Monoclonal Antibody Versus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy for Patients With Completely Resected Stage II-IIIB NSCLC Who Have No Actionable Genomic Alterations and Not Achieved a Major Pathological Response.
Source: ClinicalTrials.gov · Last updated 26 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 570 (estimated)
- First submitted
- 21 Jun 2026
- Start date
- 25 Jun 2026
- Primary completion date
- 30 Sept 2029
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT07672223
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 570
- From 25 Jun 2026 to the primary completion date, 30 Sept 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Eligible only for incomplete resection.
- Prior or planned neoadjuvant or adjuvant radiotherapy for the current malignancy.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Other illness
- Participants with a condition requiring further surgical resection, in the investigator's opinion.
- Participants with synchronous primary lung cancer or multiple primary malignancies, or a mixed histology of SCLC and NSCLC.
- History of hypersensitivity or contraindication to any active or inactive excipient of the study treatment.
Other
- Participants with diagnosis of stage IIIB with N3, and stage IIIC, IVA, and IVB NSCLC.
Who the study is looking for
- 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.
- Without actionable genomic alterations (AGAs), which should be tested at a local or central laboratory.
- Did not achieve a Major Pathological Response (MPR) as assessed by the Central Pathology Independent Review Committee (CPIRC).
- The International Association for the Study of Lung Cancer (IASLC) V9 Stage II-IIIB NSCLC, after confirmed complete surgical resection with resection margins proved microscopically free of disease (R0).
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.