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A Clinical Study of TQB2450 Combined With Anlotinib in Limited-Stage Small Cell Lung Cancer Patients

NCT06469879 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 358

Last updated 2024-07-01

No results posted yet for this study

Summary

This study is a randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of TQB2450 in combination with anlotinib as maintenance therapy in patients with limited-stage small cell lung cancer who have not progressed after chemoradiotherapy.

Conditions

  • Small Cell Lung Cancer Limited Stage

Interventions

DRUG

TQB2450+Anlotinib

TQB2450 injection test group, 1200 mg/time, strength: 600mg/20 mL, intravenous drip, day 1, every 3 weeks. Anlotinib hydrochloride capsules: 8 mg/time, strength: 10mg/capsule, 8mg/capsule, 6mg/capsule., 1 time a day (QD), continuous use for 2 weeks and stop for 1 week. TQB2450 Injection Placebo (control group): 0 mg/time, strength: 0mg/20 mL, Intravenous Drip, Day 1, every 3 weeks. Anlotinib hydrochloride capsule placebo: 0 mg/time, strength: 0mg/capsule, 1 time a day (QD), continuous use for 2 weeks and stop for 1 week.

DRUG

TQB2450 placebo + Anlotinib placebo

No drug substance is contained

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06469879 on ClinicalTrials.gov