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NCT Number: NCT05552846

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

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

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Key information

Conditions

Small-cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin Hospital, Shanghai jiaotong univestigy school of medicine

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

Shengguang Zhao, Dr

PRINCIPAL_INVESTIGATOR

Yi Xiang, Dr.

PRINCIPAL_INVESTIGATOR

Yifeng Wang

CONTACT

[email protected]

+862164370045

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

thoracic radiotherapy

Radiation

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 treatment, or until the patient no longer wishes to continue treatment.

Primary outcomes

  1. 1-year progression-free survival

    Time frame: 12 months after last patient entry

    PFS is defined as the period from the start of receiving the first EC/EP chemotherapy plus PD-1/PD-L1 inhibitor to disease progression.

Secondary outcomes

  1. 1-year overall survival

    Time frame: 12 months after last patient entry

  2. toxicities

    Time frame: 12 months after last patient entry

    Number of participants with treatment-related adverse events and the grade of adverse events as assessed by CTCAE v4.0

  3. 5-year overall survival

    Time frame: 5-year after last patient entry

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Sep 23, 2022
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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