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Adebrelimab Maintenance Therapy for LS-SCLC Post Induction Chemo-Adebrelimab Plus CRT or CRT Alone

ConditionLocalized Small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking University Cancer Hospital & Institute

About this trial

Observation and Evaluation of the Efficacy and Safety of Adalimumab Combined with Chemotherapy Followed by Radiotherapy or Radiotherapy Alone as First-Line Treatment for Limited-Stage Small Cell Lung Cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18-75 years old, male or female;

Patients with pathologically confirmed localized small cell lung cancer (as defined by the Veterans Administration Lung Study Group, VALG staging);

No anticipated need for tumor resection during the study period (including patients unsuitable for surgery or unwilling to undergo surgery);

No prior treatment for localized small cell lung cancer;

Disqualifiers

Mixed SCLC and extensive-stage SCLC;

History of other malignancies within the past 5 years or concurrent malignancies, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, or superficial or non-invasive bladder cancer;

History of uncontrollable psychiatric disorders or severe intellectual or cognitive impairment;

Active, known, or suspected autoimmune disease; however, subjects with hypothyroidism requiring only hormone replacement therapy or skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are eligible;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adebrelimab Induction Therapy Group

    Drug

    Induction Phase Adebrelimab: 1200 mg, intravenous infusion, every 3 weeks Etoposide: 100 mg/m², intravenous infusion, Days 1-3, every 3 weeks Platinum-based agent: Cisplatin 75 mg/m² or Carboplatin AUC 5, intravenous infusion on Day 1, every 3 weeks Radiotherapy: 45 Gy/30 fractions BID or 60-66 Gy/30 fractions QD. Maintenance Phase Adebrelimab: 1200 mg, intravenous infusion, every 3 weeks

  • Adebrelimab Maintenance Therapy Group

    Drug

    Concurrent chemoradiotherapy radiotherapy : 45 Gy/30 fractions BID or 60-66 Gy/30 fractions QD Etoposide: 100 mg/m², intravenous infusion, Days 1-3, every 3 weeks Platinum-based agent: Cisplatin 75 mg/m² or Carboplatin AUC 5, intravenous infusion on Day 1, every 3 weeks Maintenance therapy Adebrelimab: 1200 mg, intravenous infusion, every 3 weeks

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: Adebrelimab Induction Therapy GroupExperimental treatment 1 intervention
Group B: Adebrelimab Maintenance Therapy GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PFS

From subject enrollment to the first recorded disease progression or death from any cause, whichever occurs first

Time frame
through study completion, an average of 3 years

Secondary outcomes

1

ORR

The proportion of subjects achieving complete response (CR) or partial response (PR) as their best overall response following treatment initiation, relative to the total number of subjects.

Time frame
through study completion, an average of 3 years
2

OS

Time from subject enrollment to death from any cause.

Time frame
through study completion, an average of 3 years
3

Adverse Events

AEs that occurred from the first dose of durvalumab to 90 days after the last dose of durvalumab or start of subsequent anticancer treatment

Time frame
From the first dose of durvalumab to 90 days after the last dose of durvalumab or start of subsequent anticancer treatment
4

DCR

The proportion of subjects achieving complete response (CR), partial response (PR), or stable disease (SD) as their best overall response following treatment initiation, relative to the total number of subjects.

Time frame
through study completion, an average of 3 years

Other outcomes

Sponsors and contacts

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

Peking University Cancer Hospital & Institute

Lead sponsor

Source ClinicalTrials.gov

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