Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Etoposide

Immune Checkpoint Inhibitors

Immunomodulating Agents

Etoposide phosphate

chemo-immunotherapy followed by thoracic radiotherapy and PD-1/PD-L1 maintenance therapy

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 4 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.

thoracic radiotherapy

Yifeng Wang

Yi Xiang, Dr.

Shengguang Zhao, Dr

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

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 4 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.

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

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

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.

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

Ruijin Hospital

Prof.

Carcinoma, Non-Small-Cell Lung

Sequential chemo-immunotherapy plus standard dose of thoracic radiotherapy followed by anti-PD-1/PD-L1 maintenance therapy

Sequential chemo-immunotherapy plus decreased thoracic radiotherapy followed by anti-PD-1/PD-L1 maintenance therapy

All the enrolled patients will be patients with NSCLC who did not have PD (determined as per the RECIST v1.1) after 4 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, those enrolled patients would be treated with standard dose thoracic radiotherapy of 60 Gy/30Fx concurrently with PD-1/PD-L1 maintenance therapy, and the total maintenance therapy time should at least more than 6 months.

standar thoracic RT dose

All the enrolled patients will be patients with NSCLC who did not have PD (determined as per the RECIST v1.1) after 4 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, those enrolled patients would be treated with decreased thoracic radiotherapy of 50Gy/25Fx concurrently with PD-1/PD-L1 maintenance therapy, and the total maintenance therapy time should at least more than 6 months.

decreased thoracic RT dose

Concurrent chemoradiotherapy without disease progression followed by consolidation durvalumab is standard of care for unresectable, stage III non-small-cell lung cancer (NSCLC) (the 'PACIFIC regimen'). However, many patients with poor performance status, older age or comorbidities may be ineligible for chemotherapy due to expected high toxicity. The present study aim to investigate the efficacy and toxicities of sequential chemo-immunotherapy plus thoracic radiotherapy for elderly and/or frail stage III NSCLC patients unfit for concurrent chemoradiotherapy, and to identify the optimal thoracic dose for this patient population.

Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly and/or Frail Stage III Non-small-cell Lung Cancer

Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly and/or Frail Stage III Non-small-cell Lung Cancer Patients Unfit for Concurrent Chemoradiotherapy: an Open Label, Two Cohorts, Prospective Trial

time from treatment start until death or progression of tumor disease within one year

time from treatment start until death with in one year

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II Trial of Consolidative Thoracic Radiotherapy for ES-SCLC After Standard Care of Chemo-immunotherapy	NCT05552846	Small-cell Lung...	thoracic radiot...	18 Years - 80 Years	Ruijin Hospital
Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly and/or Frail Stage III Non-small-cell Lung Cancer	NCT05557552	Non-small Cell ...	standar thoraci... decreased thora...	18 Years - 80 Years	Ruijin Hospital
Phase II Trial of Consolidative Thoracic Radiotherapy for ES-SCLC After Standard Care of Chemo-immunotherapy	NCT05552846	Small-cell Lung...	thoracic radiot...	18 Years - 80 Years	Ruijin Hospital

Spots Global Cancer Trial Database for thoradic radiotherapy