Adebrelimab Plus Chemoradiotherapy Followed by Adebrelimab Maintenance in Limited-Stage SCLC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking University Cancer Hospital & Institute
About this trial
This is a single-arm, open-label, single-center phase II trial that will enroll 30 patients with limited-stage small-cell lung cancer to evaluate the safety and efficacy of adebrelimab combined with chemoradiotherapy followed by adebrelimab maintenance.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years, either sex. Histologically or cytologically confirmed limited-stage small-cell lung cancer (LS-SCLC) defined by Veterans Administration Lung Group (VALG) two-stage system.
Disqualifiers
Prior solid-organ, allogeneic stem-cell or planned transplantation. Immunosuppressive therapy ≤ 14 days before first adebrelimab dose (except intranasal/inhaled corticosteroids or physiological systemic doses equivalent to ≤ 10 mg/day prednisolone).
Trial design
Design model
Single group
Treatments tested in this trial
Adebrelimab with concurrent chemoradiotherapy
DrugAdebrelimab combined with chemotherapy and concurrent radiotherapy, followed by maintenance therapy with Adebrelimab until disease progression or intolerable toxicity, for up to 2 years.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: experimental 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 yearsSecondary 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 years2
OS
Time from subject enrollment to death from any cause.
Time frame
through study completion, an average of 3 years3
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 years4
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 treatmentSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: