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Recruiting NCT05552846

Phase II Trial of Consolidative Thoracic Radiotherapy for ES-SCLC After Standard Care of Chemo-immunotherapy

No phase Interventional Small-cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: thoracic radiotherapy.
Who it may be relevant to
Registry conditions: Small-cell Lung Cancer. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Consolidative Thoracic Radiotherapy for Extensive-stage Small-cell Lung Cancer Treated with Chemo-immunotherapy Followed by PD-1/PD-L1 Maintenance Therapy：an Open Label, Single Arm Prospective Trial

Overview

This is an open-label, single arm Phase II study designed to evaluate the efficacy and safety of thoracic radiotherapy for extensive-stage small-cell lung cancer treated with PD-1/PD-L1 plus etoposide platinum followed by PD-1/PD-L1 maintenance therapy

Detailed description

This study a single arm prospective phase II study. All the enrolled patients will be patients with ES-SCLC who did not have PD (determined as per the RECIST v1.1) after 6 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, those enrolled patients would be treated with thoracic radiotherapy concurrently with PD-1/PD-L1 maintenance therapy, and the total maintenance therapy time should at least more than 6 months.

Interventions

  • Radiation thoracic radiotherapy
    Four courses of carboplatin/etoposide/anti-PD-1/PD-L1 every 3 weeks All the enrolled patients will be patients with ES-SCLC who did not have PD (determined as per the RECIST v1.1) after 6 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, thoracic radiotherapy of 45 Gy/15 fractions. PD-1/PD-L1 maintenance therapy concurrently and after thoracic radiotherapy at least more than 6 months, or until intolerable toxicity, progressive disease leading to a need for other tre

Primary outcome measures

  • 1-year progression-free survival [Time frame: 12 months after last patient entry]
Secondary outcome measures (3)
  • 1-year overall survival [Time frame: 12 months after last patient entry]
  • toxicities [Time frame: 12 months after last patient entry]
  • 5-year overall survival [Time frame: 5-year after last patient entry]

Eligibility criteria

Inclusion criteria

  • Age between18 years and 80 years at time of study entry
  • ECOG performance status of 0 or 1
  • Body weight >30 kg
  • Adequate bone marrow, liver and kidney function
  • Life expectancy of at least 3 months
  • At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated with 45 Gy/15 fractions
  • Histologic or cytologic confirmation of small cell lung cancer
  • Stage III-IV disease (TNM v8)
  • Adequate pulmonary function with FEV1 >1 L or >30 % of predicted value and DLCO >30 % of predicted value
  • Patients with brain metastases are eligible provided they are asymptomatic or treated and stable on steroids and/or anticonvulsants prior to the start of treatment -

Exclusion criteria

  • Previous chemo-, immuno- or radiotherapy for SCLC
  • Major surgical procedure last 28 days
  • History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV
  • Uncontrolled intercurrent illness
  • Other active malignancy
  • Leptomeningeal carcinomatosis
  • Immunosuppressive medication
  • Pregnant or breastfeeding women

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Ruijin Hospital, Shanghai jiaotong univestigy school of medicine — Shanghai

Identifiers

NCT: NCT05552846 · 2021（212）

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗