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NCT Number: NCT06236997

Adebrelimab and Concurrent Radiochemotherapy as First-line Treatment for Extensive-stage Small-cell Lung Cancer

Patients with extensive-stage small-cell lung cancer (ES-SCLC) have poor prognosis, with limited treatment options. Chemo-immunotherapy is the standard 1st-line therapy for patients with ES-SCLC.When 4 cycles of etoposide+carboplatin (EC) or etoposide+cisplatin(EP) chemotherapy combined with PD-L1 inhibitor are effective, guidelines recommend additional thoracic radiotherapy.

In this study, the investigators bring radiotherapy forward, which means that after 2 cycles of EC chemotherapy plus Adebrelimab, participants with response(PR/CR/SD)will receive concurrent radiotherapy and 2 cycles of EC chemotherapy plus Adebrelimab, then maintenance therapy with Adebrelimab (Q3W).

The purpose of this study is to explore the safety and efficacy of Adebrelimab combined with concurrent chemoradiotherapy in untreated participants with extensive-stage small cell lung cancer.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Henan Cancer Hospital, Zhengzhou, Henan, China

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About this study

Participants receive EC chemotherapy combined with Adebrelimab for 2 cycles, and the efficacy will be evaluated. If the efficacy evaluation is SD/PR/CR, concurrent chemoradiotherapy combined with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy + Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18-75 years;
  • Histologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system) ;
  • Must sign a written informed consent form prior to any study specific procedures;
  • No prior treatment for ES-SCLC;
  • No more than 5 lesions (including metastases),and at least one measurable lesion that meets RECIST 1.1 evaluation criteria;
  • Life expectancy more than 3 months;
  • ECOG PS 0-1

Exclusion criteria

  • Previous treatment with radiochemotherapy for limited-stage small cell lung cancer;
  • Subjects who previously received systemic antitumor or Immune checkpoint inhibitor therapy ;
  • Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment;
  • Active brain metastases, Leptomeningeal metastasis(untreated central nervous system (CNS) metastases unless asymptomatic and lesion size<1cm;
  • Patients with spinal cord compression;
  • Patients with multiple liver metastases(except isolated lesion and lesion size<2cm);
  • Uncontrollable third cavity effusion (e.g. a large amount of pleural effusion, ascites, or pericardial effusion, etc.) requiring repeated drainage, which was judged by the investigator to be unsuitable for study;
  • The investigator judges that there are any patients who endanger the patient's safety, interfere with the study assessment, and have poor compliance.

Treatment and study plan

Adebrelimab

Drug

Etoposide 100mg/m2 day1-3+carboplatin AUC 5 day 1(EC) combined with Adebrelimab( PD-L1 inhibitor)1200mg day1 Q3w for 2 cycles, and the efficacy is evaluated 3 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent radiotherapy(45Gy /3Gy/qd/3w) with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy+ Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.

radiation therapy

Radiation

Etoposide 100mg/m2 day1-3+carboplatin AUC 5 day 1(EC) combined with Adebrelimab( PD-L1 inhibitor)1200mg day1 Q3w for 2 cycles, and the efficacy is evaluated 3 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent radiotherapy(45Gy /3Gy/qd/3w) with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy+ Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.

etoposide, carboplatin(EC)

Drug

Etoposide 100mg/m2 day1-3+carboplatin AUC 5 day 1(EC) combined with Adebrelimab( PD-L1 inhibitor)1200mg day1 Q3w for 2 cycles, and the efficacy is evaluated 3 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent radiotherapy(45Gy /3Gy/qd/3w) with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy+ Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.

Primary outcomes

  1. 6-m PFS rate

    Time frame: 6 months

    6-m PFS rate is defined as the percentage of participants whose disease is still progression-free at the 6th month

Secondary outcomes

  1. ORR

    Time frame: up to 24 months.

    Objective response rate is defined as the proportion of subjects who have a CR or a PR

  2. PFS

    Time frame: From date of the first treatment to the first documented disease progression, assessed up to 24 months

    Progression-free survival is defined as the time from the first treatment to the first documented disease progression

  3. OS

    Time frame: From date of the first treatment to death due to any cause, assessed up to 24 months

    Overall survival is defined as the time from the first treatment to death due to any cause.

  4. 12-m PFS rate

    Time frame: 12 months

    12-m PFS rate is defined as the percentage of participants whose disease is still progression-free at the 12th month

  5. AEs

    Time frame: up to 24 months

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Qimig Wang, Doctor

CONTACT

[email protected]

0086-13783590691

Sponsors and collaborators

Lead sponsor

Henan Cancer Hospital

Other Gov

Collaborators

  • Huazhong University of Science and Technology

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 1, 2024
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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