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A Phase Ⅱ Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy for Extensive-Stage Oligometastatic SCLC

ConditionsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsSmall Cell Lung Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNanfang Hospital, Southern Medical University

About this trial

This is an open-label, single arm Phase II study designed to evaluate the efficacy and safety of adebelizumab combined with carboplatin/Cisplatin plus (+) etoposide and concurrent radiotherapy in the first-line treatment of patients with extensive stage oligometastatic small cell lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed inform consent form

Age >= 18 years and <= 75 years

Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system)，the number of metastatic lesions ≤ 5, the number of metastatic organs ≤ 3, and no previous systemic chemotherapy, radiotherapy or immune checkpoint inhibitor treatment.

Eastern Cooperative Oncology Group performance status of 0 or 1

Disqualifiers

Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 1 week prior to randomization

Leptomeningeal disease

Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures

Uncontrolled or symptomatic hypercalcemia

Trial design

Design model

Single group

Treatments tested in this trial

  • Adebrelimab

    Drug

    Adebrelimab intravenous infusion will be administered during the induction phase (Cycles 1-2 ) and maintenance phase.

  • Carboplatin/Cisplatin

    Drug

    Carboplatin/Cisplatin intravenous infusion will be administered during the induction phase, concurrent chemoradiotherapy phase and maintenance phase(Cycles 1-4 or 6).

  • Etoposide

    Drug

    Etoposide intravenous infusion will be administered during the induction phase, concurrent chemoradiotherapy phase and maintenance phase(Cycles 1-4 or 6).

  • Radiation therapy

    Radiation

    IMRT for thoracic of 45--55Gy in 15-22 fractions，SBRT for metastases during the concurrent chemoradiotherapy phase

Treatment groups

62 Participants
are divided into 1 treatment group
Group A: Treatment (Adebrelimab, chemotherapy, radiation therapy)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

Time frame
up to approximately 30 months

Secondary outcomes

1

Overall Survival (OS)

Time frame
up to approximately 30 months
2

Objective Response Rate (ORR)

Time frame
up to approximately 30 months
3

Disease control rate (DCR)

Time frame
up to approximately 30 months
4

Duration of Response (DOR)

Time frame
up to approximately 30 months

Other outcomes

Sponsors and contacts

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

Nanfang Hospital, Southern Medical University

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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