RecruitingPhase 2NCT04539977

PD-L1 Antibody (TQB2450) Plus Chemotherapy for Previously Untreated Limited- Stage Small-cell Lung Cancer

Surgery or Radiotherapy After PD-L1 Inhibitor (TQB-2450) and Chemotherapy Induction Therapy in Patients With Limited-stage Small-cell Lung Cancer


Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Enrollment

40 participants

Start Date

Sep 1, 2020

Study Type

INTERVENTIONAL

Summary

This is a non-randomized, open-label, single-center, phase II trial to evaluate the safety and effectiveness of surgery or radiotherapy after PD-L1 inhibitor (TQB2450) and chemotherapy induction therapy followed by maintenance therapy as first-line treatment in patients limited-stage SCLC.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug called TQB2450 (a PD-L1 inhibitor) to standard chemotherapy improves outcomes for patients with limited-stage small-cell lung cancer — a fast-growing type of lung cancer that hasn't yet spread widely. **You may be eligible if...** - You are 18 or older - You have been diagnosed with small-cell lung cancer (SCLC), confirmed by biopsy - Your cancer is limited-stage or extensive-stage (locally advanced) - You are in good general health (ECOG score 0–1) - Your blood counts, liver, and kidney function are within acceptable ranges - You have at least one measurable lesion on imaging **You may NOT be eligible if...** - You have received prior chemotherapy or immunotherapy for this cancer - You have active autoimmune disease - You have uncontrolled infections (including active hepatitis or HIV) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTQB2450

Inductive therapy: TQB2450 + EC(4 cycles) Maintenance therapy: TQB2450+EC(2 cycles) followed byTQB2450 (1 year)

DRUGTQB2450

Inductive therapy: TQB2450 + EC(4 cycles) Maintenance therapy: TQB2450+EC(2 cycles) followed byTQB2450 (1 year)


Locations(1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

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NCT04539977