Non-small Cell Lung Cancer
Conditions
Brief summary
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).
Detailed description
This is a randomized, open-label, multicenter, Phase III clinical study. Participants 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) will be enrolled and randomized in a 1:1 ratio to experimental (SYS6010 + Enlonstobart) or control (Investigator's Choice of anti-PD-(L)-1 Monoclonal Antibody Regimen) group. Random factors include disease stage (Stage II / IIIA vs. Stage IIIB), Pathological type (non-squamous cell carcinoma vs. squamous cell carcinoma), and lymph node status (positive vs. negative).
Interventions
DRUGSYS6010
SYS6010
DRUGEnlonstobart
Enlonstobart
DRUGTislelizumab
administered via Intravenous (IV) injection
DRUGToripalimab ±+platinum-based doublet chemotherapy
Cisplatin; Carboplatin; Pemetrexed; Paclitaxel;
DRUGDurvalumab
Durvalumab
DRUGPembrolizumab
Pembrolizumab
DRUGNivolumab
Nivolumab
Sponsors
CSPC Megalith Biopharmaceutical Co.,Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, open-label
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Able to understand and willingness to voluntarily provide written informed consent. 2. Age 18 to 75 years, males or females. 3. Histologically confirmed squamous or non-squamous NSCLC. 4. Ability to provide qualified tumor samples. 5. Without actionable genomic alterations (AGAs), which should be tested at a local or central laboratory. 6. Did not achieve a Major Pathological Response (MPR) as assessed by the Central Pathology Independent Review Committee (CPIRC). 7. 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).
Exclusion criteria
1. Participants with a condition requiring further surgical resection, in the investigator's opinion. 2. Participants with diagnosis of stage IIIB with N3, and stage IIIC, IVA, and IVB NSCLC. 3. Eligible only for incomplete resection. 4. Participants with synchronous primary lung cancer or multiple primary malignancies, or a mixed histology of SCLC and NSCLC. 5. History of hypersensitivity or contraindication to any active or inactive excipient of the study treatment. 6. Prior or planned neoadjuvant or adjuvant radiotherapy for the current malignancy. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-Free Survival (DFS) assessed by the independent review committee (IRC) | Up to approximately 60 months | DFS was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by IRC per RECIST 1.1 or death (whatever the cause). Recurrence of disease was defined as local regional recurrence or a distant (metastatic) recurrence, confirmed by imaging and/or pathology. A second primary NSCLC was also considered to be an event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to approximately 60 months | OS was defined as the time from randomization to the date of death(whatever the cause). |
| DFS assessed by investigators | Up to approximately 60 months | DFS was defined as the time from randomization to either the date of disease recurrence as assessed by investigators per RECIST 1.1 or death (whatever the cause). Recurrence of disease was defined as local regional recurrence or a distant (metastatic) recurrence, confirmed by imaging and/or pathology. A second primary NSCLC was also considered to be an event. |
| Incidence and severity of Adverse Events (AEs) | Approximately 15 months | — |
| EORTC QLQ-30 questionnaire | Approximately 13 months | — |
| Blood concentration of SYS6010 and Enlonstobart | Approximately 13 months | — |
| Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (Nabs) | Approximately 13 months | — |
Contacts
CONTACTClinical Trials Information Group officer
Outcome results
None listed