About this trial

This prospective clinical study aims to evaluate and observe the efficacy and safety of Atezolizumab combined with Apatinib in maintenance therapy for extensive-stage small cell lung cancer using a single-arm trial design.

The study is planned to be conducted in Shaanxi Province, China, with an initial target enrollment of 60 patients. The study commenced in February 2024, and recruitment is expected to conclude around December 2025, with the trial anticipated to end by December 2026. Assuming no occurrences such as withdrawal of informed consent by subjects, intolerable adverse drug reactions, or investigator-assessed unsuitability for further participation, each participant's estimated duration of study treatment will continue until radiographically confirmed tumor progression.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntary participation with signed informed consent and good compliance for follow-up.

Age between 18 and 75 years old.

Histologically or cytologically confirmed extensive-stage small cell lung cancer (LS-SCLC) according to the AJCC 8th edition or VALG phase II staging criteria.

ECOG performance status score: 0 to 2.

Disqualifiers

Limited-stage small cell lung cancer (SCLC).

Histologically or cytologically confirmed mixed-type SCLC.

Prior use of anti-angiogenic drugs or deemed unsuitable for anti-angiogenic therapy by the investigator.

Central tumors invading major blood vessels with assessed bleeding risks.

Trial design

Design model

Single group

Treatments tested in this trial

Adebrelimab combined with Apatinib
Drug
Each treatment cycle spans 3 weeks. Sequential medication administration begins on the first day of each cycle: Atezolizumab is administered at a dosage of 1200mg on day 1, every 3 weeks, while Apatinib is given orally at a dosage of 250mg daily from day 1 to day 14, every 3 weeks, with a one-week hiatus following two weeks of continuous intake. Administration timing allows for a window of ±5 days. Subjects are required to undergo comprehensive assessments, including vital signs monitoring, anthropometric measurements, physical examinations, laboratory analyses, and performance status evaluations, to assess treatment tolerability for continuation.

Treatment groups

60 Participants

are divided into 1 treatment group

Group A: Adebrelimab combined with ApatinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival

Progression free survival (PFS) refers to the time from recording the first chemotherapy treatment to the date of disease progression, as assessed by researchers.

Time frame

Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years

Secondary outcomes

1

Overall Survival

Overall survival (OS) refers to the time that researchers evaluate from recording the first chemotherapy to death (of any cause).

Time frame

The maximum time from receiving treatment to dying for any reason is 4 years.

2

Objective response rate

Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with response of Complete Response or Partial Response, will be assessed up to 1 years.

Time frame

Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years

3

Complete Response rate

Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with response of Complete Response, will be assessed up to 1 years.

Time frame

up to 1 years

4

Duration of Response

Duration of Response（DoR）refers to the time from the first assessment as CR or PR to the first assessment as PD or (due to any reason) death

Time frame

Duration of Response（DoR）analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 1 years

Adebrelimab + Apatinib in SCLC Maintenance Therapy

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts