About this trial
This exploratory clinical study evaluates the efficacy and safety of combining benmelstobart (a PD-L1 inhibitor) with anlotinib (a multi-target anti-angiogenic TKI) as a first-line, chemotherapy-free treatment for elderly patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
Benmelstobart Combined With Anlotinib
DrugBenmelstobart: Administered via intravenous infusion at a dose of 1200 mg every 3 weeks (Q3W). Anlotinib Hydrochloride: Administered orally at a dose of 10 mg daily, taken for 2 consecutive weeks followed by 1 week off, in repeated 3-week (21-day) cycles.
Treatment groups
Trial outcomes
Primary outcomes
Objective Response Rate (ORR)
Percentage of participants who achieve a confirmed Complete Response (CR) or Partial Response (PR) evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Incidence and Severity of Adverse Events (AEs)
Safety and tolerability profile evaluated by assessing the incidence, type, and severity of Adverse Events (AEs), Serious Adverse Events (SAEs), and clinically significant abnormal laboratory test values, graded according to NCI CTCAE v5.0.
Secondary outcomes
Progression-Free Survival (PFS)
Length of time from the start of treatment until the first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.
Overall Survival (OS)
Length of time from the start of treatment until death from any cause.
Sponsors and contacts
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