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A Study on the First-line Treatment of Small Cell Lung Cancer With Adebrelimab and Vunakizumab and Chemotherapy

ConditionsVunakizumabAdebrelimabSmall Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Cancer Hospital

About this trial

This study is a prospective, single-center, single-arm clinical trial, with a planned enrollment of 28 cases.The first Adebrelimab +Vunakizumab +EC was administered within 72 hours after enrollment for 4 to 6 cycles.At the end of the combination phase, non-PD subjects entered the maintenance treatment period of Adebrelimab plus Vunakizumab.Treatment will continue until any of the following situations occur: disease progression in the subject, intolerable toxic and side effects, comorbidiments that affect further treatment, the investigator's decision to withdraw the subject from the study, or other reasons for non-compliance with the study treatment or the study procedures or protocols.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Age: 18 to 75 years old, both male and female are acceptable.

2. Histologically or cytologically confirmed extensive-stage small cell Lung cancer (according to the Veterans Administration Lung Study Group, VALG staging);

3. No previous systematic treatment;

4. Life expectancy exceeds 3 months;

Disqualifiers

1. There is a large amount of uncontrolled pleural effusion, pericardial effusion or ascites;

2. The following heart disorders exist: (1) According to NYHA cardiac function classification, (1) Grade III-IV cardiac function; (2) Unstable angina pectoris or acute ischemia indicated by electrocardiogram or myocardial infarction occurred within one year; (3) Clinically significant supraventricular or ventricular arrhythmias and other conduction system abnormalities (including QTc interval ≥ 450ms in men and ≥470ms in women); (4) Clinically significant pericardial and myocardial diseases.

3. Insufficient bone marrow reserve or organ function;

4. Systemic immunomodulators (including but not limited to thymosin, interferon or interleukin-2) have been used for treatment within 4 weeks before enrollment;

Trial design

Design model

Single group

Treatments tested in this trial

  • Vunakizumab (IL-17A inhibitor)

    Drug

    Vunakizumab , 240mg, D1, subcutaneous injection, Q4W.

  • Adebrelimab

    Drug

    Adebrelimab, 1200 mg, D1, intravenous drip, Q3W

  • Chemotherapy

    Drug

    Etoposide, 100mg /m², D1-3, IV, Q3W. Carboplatin, AUC 5, D1, IV, Q3W

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Adebrelimab in combination with Vunakizumab and chemotherapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

12-month PFS rate

Time frame
12-month

Secondary outcomes

1

Progression-free survival (PFS）

Time frame
12- months
2

Overall survival (OS）

Time frame
24-months
3

Objective response rate (ORR）

Time frame
Each 2 cycles can last up to 3 months (each cycle is 21 days).
4

Disease Control Rate (DCR）

Time frame
Each 2 cycles can last up to 3 months (each cycle is 21 days).

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Fujian Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: