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

Primary Purpose

Small-cell Lung Cancer

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

thoracic radiotherapy

About this trial

This is an interventional treatment trial for Small-cell Lung Cancer focused on measuring thoradic radiotherapy, immune checkpoint inhibitors, chemo-immunotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ruijin Hospital, Shanghai jiaotong univestigy school of medicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

experimental group

Arm Description

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

Outcomes

Primary Outcome Measures

1-year progression-free survival

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 Outcome Measures

1-year overall survival

toxicities

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

5-year overall survival

Full Information

NCT ID

NCT05552846

First Posted

September 21, 2022

Last Updated

September 21, 2022

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05552846

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 30, 2022 (Anticipated)

Primary Completion Date

September 30, 2025 (Anticipated)

Study Completion Date

September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small-cell Lung Cancer

Keywords

thoradic radiotherapy, immune checkpoint inhibitors, chemo-immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

experimental group

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

thoracic radiotherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

1-year progression-free survival

Description

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.

Time Frame

12 months after last patient entry

Secondary Outcome Measure Information:

Title

1-year overall survival

Time Frame

12 months after last patient entry

Title

toxicities

Description

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

Time Frame

12 months after last patient entry

Title

5-year overall survival

Time Frame

5-year after last patient entry

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Ruijin Hospital, Shanghai jiaotong univestigy school of medicine

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200025

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yifeng Wang

Phone

+862164370045

qwx12055@rjh.com.cn

First Name & Middle Initial & Last Name & Degree

Yi Xiang, Dr.

First Name & Middle Initial & Last Name & Degree

Shengguang Zhao, Dr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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