A Retrospective Real-World Study on the Efficacy and Safety of Anlotinib Hydrochloride Combined With Immunotherapy Maintenance Therapy Following Standard Chemoimmunotherapy for ES-SCLC (ALTER-L059)

NCT06982287 | Not Yet Recruiting DMC

• 1 other identifier: ALTER-L059
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This retrospective real-world study aims to evaluate the efficacy and safety of anlotinib hydrochloride combined with immunotherapy as maintenance therapy following standard chemoimmunotherapy in extensive-stage small cell lung cancer (ES-SCLC).The study population consists of treatment-naïve ES-SCLC patients who did not progress after induction chemoimmunotherapy and subsequently received maintenance therapy with anlotinib plus immunotherapy. The primary objectives are progression-free survival (PFS)，overall survival (OS) , and safety.

Conditions

Small Cell Lung Cancer Extensive Stage

Outcome Measures

Primary Outcomes (1)

• PFS2

  Progression-free survival from the initiation of anlotinib combined with immunotherapy maintenance treatment.

  up to 12 months

Secondary Outcomes (7)

• PFS

  up to 12 months

• 6-month PFS rate

  up to 12 months

• 12-month PFS rate

  up to 12 months

• OS

  From diagnosis until death (up to 24 months)

• 6-month OS rate

  up to 12 months

Study Arms (1)

Experimental Group

patients treated with anlotinib Hydrochloride combined with immunotherapy maintenance therapy following standard chemoimmunotherapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with treatment-naïve extensive-stage small cell lung cancer (ES-SCLC) who achieved non-progression after chemoimmunotherapy induction and received anlotinib plus immunotherapy maintenance therapy

You may qualify if:

• Male or female patients aged 18 years or older;
• Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) (per the Veterans Administration Lung Study Group \[VALG\] staging criteria);
• Patients who previously received chemotherapy for limited-stage SCLC must have undergone curative-intent therapy (e.g., chemotherapy, radiotherapy, or chemoradiotherapy) and have a treatment-free interval of at least 6 months from the end of prior therapy (last chemotherapy cycle or radiotherapy) to the diagnosis of ES-SCLC;
• At least one measurable target lesion (per RECIST version 1.1 criteria);
• No disease progression after receiving 4-6 cycles of first-line chemoimmunotherapy induction therapy for ES-SCLC;
• ECOG performance status: 0-2;
• Life expectancy ≥3 months.

You may not qualify if:

• Patients with limited-stage SCLC who previously received chemotherapy and underwent curative-intent therapy (e.g., chemotherapy, radiotherapy, or chemoradiotherapy) but experienced disease recurrence within 6 months after completion of prior therapy;
• Patients with limited-stage SCLC who previously received immunotherapy agents (e.g., PD-1/PD-L1 inhibitors) or anti-angiogenic agents (e.g., Anlotinib, Apatinib, Bevacizumab);
• Patients with extensive-stage small cell lung cancer (ES-SCLC) who developed disease progression during induction therapy with a standard chemoimmunotherapy regimen;
• Active autoimmune diseases requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose;
• Patients with coagulation dysfunction, defined as an International Normalized Ratio (INR) \>1.5 or activated partial thromboplastin time (APTT) \>1.5 × upper limit of normal (ULN), and/or those with a bleeding tendency;
• Patients deemed by the inves.

Sponsors & Collaborators

• Yong Fang: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 21, 2025
• Study Start: August 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share