Adebrelimab + Apatinib in SCLC Maintenance Therapy

NCT06475209 | Recruiting Phase 2 DMC

• 1 other identifier: 202404-25
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SCLC

Keywords

SCLC; Adebrelimab; Apatinib; Maintenance Therapy

Outcome Measures

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.

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

Secondary Outcomes (4)

• Overall Survival

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

• Objective response rate

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

• Complete Response rate

  up to 1 years

• Duration of Response

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

Study Arms (1)

Adebrelimab combined with Apatinib

EXPERIMENTAL

Evaluation of the Efficacy and Safety of Adebrelimab in Combination with Apatinib in Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer Each treatment cycle spans 3 weeks. Sequential medication administration begins on the first day of each cycle: Adebrelimab 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.

Drug: Adebrelimab combined with Apatinib

Interventions

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.

Adebrelimab combined with Apatinib

Eligibility Criteria

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

You may qualify if:

• 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.
• Absence of disease progression after receiving 4-6 cycles of platinum-based chemotherapy combined with Atezolizumab induction therapy.
• Recovery of non-hematologic adverse reactions to grade 1 (except for alopecia, skin pigment changes, or as determined by the investigator) following induction therapy.
• Time from the end of induction treatment (last dose) to initiation of maintenance treatment ≤ 6 weeks.
• At least one measurable lesion assessed by the investigator according to RECIST 1.1.
• Expected life expectancy of at least 3 months.
• Normal function of major organs, meeting the following criteria:
• Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L (grade 1 according to CTCAE 5.0); platelets ≥ 100×10\^9/L; hemoglobin \> 80g/L.
• Renal function: Creatinine ≤ 1.5 times the upper limit of normal (ULN), grade 1 according to CTCAE. Note: If creatinine is greater than 1.5 times the ULN, creatinine clearance must be \> 50ml/min.
• Liver function: Bilirubin ≤ 1.5 times ULN (grade 1 according to CTCAE), patients with Gilbert's syndrome bilirubin ≤ 3.0 times ULN; AST and ALT ≤ 3.0×ULN.
• Coagulation indicators: International normalized ratio (INR) ≤ 1.55 (if the patient is receiving a stable dose of therapeutic warfarin or low molecular weight heparin, INR is usually between 2 and 3), PTT \< 1.2 times ULN.
• Women of childbearing potential must agree to use contraception during the study and for 6 months after the end of the study (such as an intrauterine device, contraceptive pills, or condoms); serum or urine pregnancy test must be negative within 1 week before enrollment, and must be non-lactating patients; men must agree to use contraception during the study and for 6 months after the end of the study.

You may not qualify if:

• 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.
• Factors affecting oral medication (e.g., dysphagia, chronic diarrhea, intestinal obstruction).
• Major surgical procedures, incisional biopsies, or significant traumatic injuries within 4 weeks prior to enrollment.
• Participation in another investigational drug clinical trial within the past 4 weeks.
• Medical history including:
• Untreated or symptomatic brain metastases or spinal cord compression.
• Concurrent active malignant tumors requiring treatment.
• History of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency diseases, or organ transplant recipients.
• History of substance abuse disorders not amenable to treatment or psychiatric disorders.
• Presence of any severe and/or uncontrolled diseases including:
• Poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg).
• Ischemic heart disease or myocardial infarction of grade I or higher, arrhythmias (including QTc ≥ 450ms for males, QTc ≥ 470ms for females), and ≥ grade 2 congestive heart failure (New York Heart Association \[NYHA\] functional classification); or left ventricular ejection fraction (LVEF) \< 50% based on echocardiography.

Sponsors & Collaborators

• Tang-Du Hospital: lead
• Jiangsu Hengrui Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Tangdu Hospital Affiliated to the Fourth Military Medical University

Xi'an, Shannxi, 710038, China

RECRUITING

MeSH Terms

Interventions

apatinib

Central Study Contacts

Jie Min, Dr

CONTACT

13709202616; Minjie1504@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start: June 20, 2024
• Primary Completion: December 20, 2025
• Study Completion (Estimated): December 20, 2026
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

CN (1)