Adebrelimab Combined with Chemotherapy and Thoracic Radiotherapy for First-line Treatment of ES-SCLC

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJinming Yu

About this trial

This phase III trial compares the effect of adding radiation therapy to the usual maintenance therapy with adebrelimab versus adebrelimab alone in patients who have already received debrelimab plus chemotherapy for the treatment of extensive stage small cell lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-75 years, male or female;

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

ECOG performance status score 0 ~ 1;

No prior line of systemic therapy for ES-SCLC;

Disqualifiers

Histologically or cytologically determined as a mixed pathological type with components such as non-small cell lung cancer;

Active or untreated CNS metastases detected by computed tomography (CT) or magnetic resonance imaging (MRI) during the screening period and previous imaging assessments;

Spinal cord compression that is not relieved by surgery and/or radiotherapy;

Clinically symptomatic third space effusion requiring repeated drainage within 2 weeks, such as pericardial effusion, pleural effusion, and abdominal effusion that are still uncontrollable by pumping or other treatments;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adebrelimab

    Drug

    Given:IV

  • Radiation Therapy

    Radiation

    Undergo radiation therapy

Treatment groups

524 Participants
are divided into 2 treatment groups
Group A: Arm Combined RadiotherapyExperimental treatment 2 interventions
Group B: Arm Non-radiotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

PFS

Time frame
Up to approximately 36 months
2

OS

Time frame
Up to approximately 36 months

Secondary outcomes

1

ORR

Time frame
Up to approximately 36 months
2

DoR

Time frame
Up to approximately 36 months
3

DCR

Time frame
Up to approximately 36 months
4

6m and 1-year PFS rate

Time frame
6 Months and 12 Months

Other outcomes

1

To detect biomarkers associated with efficacy

Time frame
Up to approximately 36 months

Locations

This trial has no locations.

Sponsors and contacts

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

Jinming Yu

Lead sponsor

Shandong Cancer Hospital and Institute

Sponsor institution

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