Health TrialsbyHealthPanel

Adebrelimab Plus Apatinib for Maintenance Therapy of Extensive Stage Small Cell Lung Cancer

ConditionSmall Cell Lung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYunpeng Liu

About this trial

To evaluate the efficacy and safety of maintenance therapy with Adebrelimab plus Apatinib for extensive stage small cell lung cancer after first-line induction of Adebrelimab plus chemotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants voluntarily enrolled in this study and signed an informed consent form, were compliant and co-operated with follow-up visits;

Age 18 years and above, male and female;

Diagnosis of extensive stage small cell lung cancer (ES-SCLC) confirmed by histology or pathology (according to the American Veterans Lung Cancer Association, VALG stage);

ECOG physical condition score is 0-2;

Disqualifiers

Patients with meningeal metastases;

Prior treatment with any T-cell co-stimulation or immune checkpoint therapy, including, but not limited to, cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, CD137 agonists, or other agents that target T cells;

Prior treatment with apatinib;

Factors affecting oral administration of medications such as inability to swallow, post gastrointestinal resection, chronic diarrhoea, intestinal obstruction;

Trial design

Design model

Single group

Treatments tested in this trial

  • Adebrelimab Injection

    Drug

    Adebrelimab injection (1200mg) will be administered by intravenous infusion during the induction phase and maintenance phase on day 1 in a 3-week treatment cycle.

  • Apatinib Mesylate Tablets

    Drug

    Apatinib mesylate tablets (250 mg) will be administered orally in a 3-week treatment cycle, once a day.

  • Carboplatin

    Drug

    Carboplatin (AUC 4-5mg/mL/min) intravenous infusion will be administered during the induction phase on day 1 in a 3-week treatment cycle.

  • Cisplatin

    Drug

    Cisplatin (75mg/m2) intravenous infusion will be administered during the induction phase on day 1 in a 3-week treatment cycle.

  • Etoposide

    Drug

    Etoposide(100mg/m2) intravenous infusion will be administered during the induction phase from day 1 to 3 in a 3-week treatment cycle.

Treatment groups

38 Participants
are divided into 1 treatment group
Group A: Adebrelimab+Chemotherapy→Adebrelimab+ ApatinibExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

To evaluate the efficacy of anti-tumor by Resist1.1 (In months)

Time frame
baseline up to approximately 6 month

Secondary outcomes

1

Objective response rate (ORR)

To evaluate the efficacy of anti-tumor by Resist1.1 (In percent)

Time frame
baseline up to approximately 6 month
2

Disease control rate (DCR)

To evaluate the efficacy of anti-tumor by Resist1.1(In percent)

Time frame
baseline up to approximately 6 month
3

Duration of Response (DOR)

To evaluate the efficacy of anti-tumor by Resist1.1(In months)

Time frame
baseline up to approximately 12 months
4

Overall survival (OS)

To evaluate the efficacy of anti-tumor by Resist1.1(In months)

Time frame
baseline up to approximately 12 month

Other outcomes

1

Correlation of biomarkers and tumour response

Biomarkers Include: haematopoietic factors in pg/mL (IL-6,IL-8, IL-10, etc.), PD-L1 expression in TPS, T-cell subsets in percent, T-cell immunoprecision typing and regulatory T-cell counts in percent.

Time frame
baseline up to approximately 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yunpeng Liu

Lead sponsor

China Medical University, China

Sponsor institution

Jiangsu HengRui Medicine Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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