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A study on the efficacy and safety of sequential maintenance treatment with PD-1/CTLA-4 bispecific antibody and anlotinib after combination of PD-1/CTLA-4 bispecific antibody and chemotherapy in second-line treatment of advanced driver gene-negative NSCLC

A study on the efficacy and safety of sequential maintenance treatment with PD-1/CTLA-4 bispecific antibody and anlotinib after combination of PD-1/CTLA-4 bispecific antibody and chemotherapy in second-line treatment of advanced driver gene-negative NSCLC

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124158
Enrollment
Unknown
Registered
2026-05-08
Start date
2026-05-10
Completion date
Unknown
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer

Interventions

Test group:Sequential maintenance therapy with PD-1/CTLA-4 bispecific antibody and anlotinib after combination of PD-1/CTLA-4 bispecific antibody and chemotherapy

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), and driver gene negative; 2. Subjects whose first-line treatment failed and who have not used the Aito combination antibody or O+Y regimen; 3. Subjects must have measurable target lesions assessed by CT or MRI. 4. Expected survival >=3 months.

Exclusion criteria

Exclusion criteria: 1. Driver gene positive; 2. First-line treatment using Nivolumab and Ipilimumab (O+Y) regimen or QL1706 or Cadonilimab; 3. Within 2 weeks prior to the first dose, systemic use of corticosteroids or other immunosuppressive drugs; 4. Developed other malignant tumours within =5 years before the first dose; 5. Presence of any active autoimmune disease or a history of autoimmune disease that may recur.

Design outcomes

Primary

MeasureTime frame
Progression free survival, PFS;

Secondary

MeasureTime frame
Disease control rate, DCR;Duration of relief, DOR;Objective response rate, ORR;

Countries

China

Contacts

Public ContactJuntao Zou

The First Affiliated Hospital of Nanchang University

ndyfy09628@ncu.edu.cn+86 791 86319861

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026