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Sugemalimab as Consolidation Therapy in Patients With LS-SCLC Following cCRT or sCRT

ConditionLimited Stage Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this trial

The purpose of this study was to evaluate the efficacy of sugemalimab consolidation therapy versus placebo in patients with LS-SCLC who had not progressed following Concurrent or Sequential Chemoradiotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Histologically or cytologically diagnosed mixed small cell lung cancer or non-small cell lung cancer.

Extensive-stage small cell lung cancer.

Has malignant pleural or pericardial effusion.

Previously received systemic anti-tumor therapy for SCLC or anti-tumor therapy with immune checkpoint inhibitors.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sugemalimab

    Drug

    Recombinant anti-PD-L1 fully human monoclonal antibody

  • Placebo

    Drug

    Placebo of Sugemalimab

Treatment groups

346 Participants
are divided into 2 treatment groups
Group A: Experimental armExperimental treatment 1 intervention
Group B: Control armPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progress Free Survival(PFS)

Evaluated according to RECIST 1.1 criteria by researchers.

Time frame
up to 36 months

Secondary outcomes

1

Overall Survival(OS)

Time frame
up to 36 months
2

Progress Free Survival rate

Evaluated according to RECIST 1.1 criteria by researchers.

Time frame
record in 12、18 and 24 months
3

Overall Survival rate

Evaluated according to RECIST 1.1 criteria by researchers.

Time frame
record in 12、18 and 24 months
4

Objective response rate(ORR)

Evaluated according to RECIST 1.1 criteria by researchers.

Time frame
up to 36 months

Other outcomes

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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