CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 40 target
Drug / intervention
TQB2450 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Histological or cytological diagnosis of SCLC, extensive or limited stage (locally advanced)
  • ✓At least 1 measurable lesion per RECIST 1.1
  • ✓Life expectancy at least 12 weeks
  • ✓Aged 18 years or older
Key exclusion· 16
  • ✕Prior systemic anti-cancer treatment for SCLC (surgery, radiotherapy, chemotherapy, targeted therapy, experimental treatment)
  • ✕Cancer other than SCLC within 5 years (except cervical carcinoma in situ, cured basal cell carcinoma, bladder epithelial tumor)
  • ✕Active or suspected autoimmune disease or autoimmune paraneoplastic syndrome requiring systemic treatment
  • ✕Unstable systemic disease (active infection, uncontrolled hypertension, unstable angina, heart failure ≥NYHA Grade II, recent MI, severe arrhythmia, liver/kidney/metabolic disease)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04539977
NCT04539977Phase 2RecruitingUpdate OverdueUpdated 37mo ago · Completion was 30mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

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

Shanghai Pulmonary Hospital, Shanghai, China·interventional·Posted Sep 7, 2020·Updated May 9, 2023

In Brief

A Phase 2 clinical trial evaluating TQB2450 for Small-cell Lung Cancer. Currently recruiting, targeting 40 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall-cell Lung Cancer
CountriesChina
Collaborators--

Timeline

Phase 2Recruiting
202120222023202420252026202720282029
First PostedSep 7, 2020
Enrollment StartSep 1, 2020
Primary CompletionDec 31, 2023
Study CompletionDec 31, 2028
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 5.8 years ago

Interventions

TQB2450drug

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

TQB2450drug

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