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Trial Title:
Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly And/or Frail Stage III Non-small-cell Lung Cancer
NCT ID:
NCT05557552
Condition:
Non-small Cell Lung Cancer Stage III
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
thoradic radiotherapy
non-small-cell lung cancer
chemo-immunotherapy
survival
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
standar thoracic RT dose
Description:
All the enrolled patients will be patients with NSCLC who did not have PD (determined as
per the RECIST v1.1) after 4-6 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.
Arm group label:
standar thoracic RT dose
Intervention type:
Radiation
Intervention name:
decreased thoracic RT dose
Description:
All the enrolled patients will be patients with NSCLC who did not have PD (determined as
per the RECIST v1.1) after 4-6 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.
Arm group label:
decreased thoracic RT dose
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥18 years at time of study entry
2. Histologically documented diagnosis of unresectable stage III NSCLC;
3. Fully-informed written consent obtained from patients;
4. 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；
5. Adequate bone marrow, liver and kidney function
6. Life expectancy of at least 3 months
7. At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated
8. Histologic or cytologic confirmation of small cell lung cancer
9. Adequate pulmonary function with FEV1 >1 L or >30 % of predicted value and DLCO >30
% of predicted value
Exclusion Criteria:
1. Previous chemo-, immuno- or radiotherapy for NSCLC
2. Major surgical procedure last 28 days
3. History of allogenic organ transplantation, autoimmune disease, immunodeficiency,
hepatitis or HIV
4. Uncontrolled intercurrent illness
5. Other active malignancy
6. Leptomeningeal carcinomatosis
7. Immunosuppressive medication
8. Pregnant or breastfeeding women
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ruijin Hospital, Shanghai jiaotong univestigy school of medicine
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Recruiting
Contact:
Last name:
Yifeng Wang
Phone:
+862164370045
Email:
qwx12055@rjh.com.cn
Contact backup:
Last name:
Yi Xiang, Dr.
Contact backup:
Last name:
Shengguang Zhao, Dr
Start date:
September 30, 2022
Completion date:
September 30, 2026
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05557552
