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

NCT07849712 | Not Yet Recruiting

• 1 other identifier: IRB-2026-37（IIT）
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Non-small Cell Lung Cancer (NSCLC) Stage IV; Locally Advanced Non-Small Cell Lung Cancer; Metastatic Non-small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer; Advanced Non-Small Cell Lung Cancer; PD-L1 Inhibitor; Anti-Angiogenesis; Benmelstobart

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 24 months

• 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.

  Up to 24 months.

Secondary Outcomes (2)

• Progression-Free Survival (PFS)

  Up to 24 months.

• Overall Survival (OS)

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

Study Arms (1)

Benmelstobart + Anlotinib

EXPERIMENTAL

Drug: Benmelstobart Combined With Anlotinib

Interventions

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.

Benmelstobart + Anlotinib

Eligibility Criteria

• Age: 75 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (10)

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• Voruganti T, Soulos PR, Mamtani R, Presley CJ, Gross CP. Association Between Age and Survival Trends in Advanced Non-Small Cell Lung Cancer After Adoption of Immunotherapy. JAMA Oncol. 2023 Mar 1;9(3):334-341. doi: 10.1001/jamaoncol.2022.6901.

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Yanjun Xu, M.D.

CONTACT

+86 0571-88122222; xuyj1411@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 30, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)