SCLC, Limited Stage / Tislelizumab + Anlotinib · Phase 2 Trial

A Phase II Study of Tislelizumab Plus Anlotinib Consolidation After Chemoradiotherapy in LS-SCLC

ClinicalTrials.gov · September 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a study registration for a Phase II single-arm trial of tislelizumab plus anlotinib consolidation in limited-stage SCLC patients who did not progress after chemoradiotherapy. No outcomes have been reported in this registry record, and the study is currently recruiting. The planned primary endpoints are progression-free survival and overall survival, measured to 36 and 48 months respectively.

What was studied

Phase 2, Interventional, Single Group, Open label, Treatment purpose. SCLC, Limited Stage; age from 18 Years; to 75 Years. Intervention: Tislelizumab + Anlotinib. n = 20. 1 site: China.

Key findings

Safety

This is a registry record only; no efficacy or safety outcomes have been reported.

Who this may help

Results are not yet available. When completed, this trial will provide preliminary safety and efficacy data on tislelizumab plus anlotinib consolidation in LS-SCLC; a small single-arm design will require confirmation in larger controlled trials before informing practice changes.

Plain-language summary

Phase II single-arm trial recruiting to evaluate an immune checkpoint inhibitor plus tyrosine kinase inhibitor combination in limited-stage SCLC; no results are posted in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Progression Free Survival (PFS) (assessed at Up to 36 months); Overall Survival (OS) (assessed at Up to 48 months)

DesignPhase 2, Interventional, Single Group, Open label, Treatment purpose

PopulationSCLC, Limited Stage; age from 18 Years; to 75 Years

Sample size20

InterventionTislelizumab + Anlotinib

Setting1 site: China

Reported figures

Quoted from the source exactly as published.

Planned enrollment20

Primary outcome measure 1Progression Free Survival, up to 36 months

Primary outcome measure 2Overall Survival, up to 48 months

PhasePHASE 2

Clinical bottom line

Caveats

This is a registry record only; no efficacy or safety outcomes have been reported.
Single-arm design without control group limits ability to assess relative benefit.
Small planned enrollment (n=20) limits statistical power.
Study is actively recruiting; results are not yet available.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Prospective single-arm Phase II design; no control arm limits comparator evidence.

Directness

strong

Directly addresses consolidation therapy in LS-SCLC after chemoradiotherapy; clinically relevant population.

Consistency

insufficient

No results reported; consistency cannot be assessed against existing evidence.

Risk of bias

limited

Single-arm design without blinding introduces bias risk; lacks concurrent control.

Sample adequacy

limited

Estimated enrollment of 20 participants is small; underpowered for definitive efficacy claims.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07815223). This is a study registration, not published results. Lead sponsor: Yantai Yuhuangding Hospital. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 20 participants (ESTIMATED). Conditions: SCLC, Limited Stage. Interventions: DRUG: Tislelizumab + Anlotinib. Primary outcome measures: Progression Free Survival (PFS) , Up to 36 months; Overall Survival (OS) , Up to 48 months. Brief summary: This prospective, single-arm, phase II study aims to evaluate the efficacy and safety of tislelizumab plus anlotinib as consolidation therapy in patients with limited-stage small cell lung cancer (LS-SCLC) who have not progressed following concurrent or sequential chemoradiotherapy.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

SCLC, Limited StageTislelizumab + AnlotinibYantai Yuhuangding HospitalNCT07815223