Back to resultsSequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly and/or Frail Stage III Non-small-cell Lung Cancer
Primary Purpose
Non-small Cell Lung Cancer Stage III
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
standar thoracic RT dose
decreased thoracic RT dose
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer Stage III focused on measuring thoradic radiotherapy, non-small-cell lung cancer, chemo-immunotherapy, survival
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years at time of study entry
- Histologically documented diagnosis of unresectable stage III NSCLC;
- Fully-informed written consent obtained from patients;
- Unfit for concurrent chemoradiotherapy as determined by the multi-disciplinary team board due to one of the following reasons: (1) ECOG 2; (2)age≥70;(3) ECOG 1 and CCI≥1；
- 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
- Histologic or cytologic confirmation of small cell lung cancer
- Adequate pulmonary function with FEV1 >1 L or >30 % of predicted value and DLCO >30 % of predicted value
Exclusion Criteria:
- Previous chemo-, immuno- or radiotherapy for NSCLC
- 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 2
Arm Type
Experimental
Experimental
Arm Label
standar thoracic RT dose
decreased thoracic RT dose
Arm Description
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
Outcomes
Primary Outcome Measures
progression-free survival
time from treatment start until death or progression of tumor disease within one year
Secondary Outcome Measures
1-year overall survial
time from treatment start until death with in one year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 within one year
Safety and Tolerability
5-year overall survival
Time from treatment start until death
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05557552
Brief Title
Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly and/or Frail Stage III Non-small-cell Lung Cancer
Official Title
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer Stage III
Keywords
thoradic radiotherapy, non-small-cell lung cancer, chemo-immunotherapy, survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standar thoracic RT dose
Arm Type
Experimental
Arm Description
Sequential chemo-immunotherapy plus standard dose of thoracic radiotherapy followed by anti-PD-1/PD-L1 maintenance therapy
Arm Title
decreased thoracic RT dose
Arm Type
Experimental
Arm Description
Sequential chemo-immunotherapy plus decreased thoracic radiotherapy followed by anti-PD-1/PD-L1 maintenance therapy
Intervention Type
Radiation
Intervention Name(s)
standar thoracic RT dose
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
decreased thoracic RT dose
Intervention Description
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.
Primary Outcome Measure Information:
Title
progression-free survival
Description
time from treatment start until death or progression of tumor disease within one year
Time Frame
12 months after last patient entry
Secondary Outcome Measure Information:
Title
1-year overall survial
Description
time from treatment start until death with in one year
Time Frame
12 months after last patient entry
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 within one year
Description
Safety and Tolerability
Time Frame
12 months after last patient entry
Title
5-year overall survival
Description
Time from treatment start until death
Time Frame
5-years 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
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years at time of study entry
Histologically documented diagnosis of unresectable stage III NSCLC;
Fully-informed written consent obtained from patients;
Unfit for concurrent chemoradiotherapy as determined by the multi-disciplinary team board due to one of the following reasons: (1) ECOG 2; (2)age≥70;(3) ECOG 1 and CCI≥1；
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
Histologic or cytologic confirmation of small cell lung cancer
Adequate pulmonary function with FEV1 >1 L or >30 % of predicted value and DLCO >30 % of predicted value
Exclusion Criteria:
Previous chemo-, immuno- or radiotherapy for NSCLC
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
Email
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
No
Learn more about this trial
Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly and/or Frail Stage III Non-small-cell Lung Cancer
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