An Exploratory Clinical Study Of Bempemab Combined With Anlotinib As First-Line Treatment For Elderly Patients With Locally Advanced Or Metastatic Non-Small-Cell Lung Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorZhejiang Cancer Hospital

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 volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Benmelstobart Combined With Anlotinib

    Drug

    Benmelstobart: 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

30 Participants
are divided into 1 treatment group
Group A: Benmelstobart + AnlotinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 24 months
2

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.

Time frame
Up to 24 months.

Secondary outcomes

1

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.

Time frame
Up to 24 months.
2

Overall Survival (OS)

Length of time from the start of treatment until death from any cause.

Time frame
Up to 24 months (or survival follow-up up to 1 year after disease progression)

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: