About this trial
This study aims to evaluate the efficacy and safety of RC148 combined with platinum-based chemotherapy versus Tislelizumab combined with platinum-based chemotherapy in participants with locally advanced or metastatic Squamous NSCLC who have not received first-line treatment. Participants will: Take RC148 or Tislelizumab combined with platinum-based chemotherapy until the end of the research.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily participate in the study and signed the Informed Consent Form (ICF).
Be willing to and able to participate in the trial and comply with the follow up procedures;
Male or female, aged 18-75 years.
Expected survival ≥ 3 months.
Disqualifiers
Histopathologically or cytologically confirmed non-squamous non-small cell lung cancer.
Squamous NSCLC with known EGFR sensitive mutations and ALK fusions; squamous NSCLC with known driver gene for which first-line approved treatment options exist.
Presence of active brain metastases.
Imaging at screening shows obvious tumor necrosis and cavitation, and the investigator judges that participation in the study will cause bleeding risk.
Trial design
Parallel
Treatments tested in this trial
RC148 plus Carboplatin and Paclitaxel
DrugRC148, Carboplatin, Paclitaxel
Tislelizumab plus Carboplatin and Paclitaxel
DrugTislelizumab, Carboplatin, Paclitaxel
Treatment groups
Trial outcomes
Primary outcomes
Progression Free Survival (PFS)
PFS is assessed in accordance with RECIST v1.1
Secondary outcomes
Overall Survival (OS)
OS
PFS (assessed by the investigator(s))
PFS assessed by the investigator(s) is assessed in accordance with RECIST v1.1
Objective Response Rate (ORR)
ORR is assessed in accordance with RECIST v1.1
Duration of Response (DoR)
DoR is assessed in accordance with RECIST v1.1
Sponsors and contacts
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