Clinical trial NCT05557552: 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
Overall status: RECRUITING
Phase: NA
Conditions: Non-small Cell Lung Cancer Stage III
Keywords: thoradic radiotherapy
non-small-cell lung cancer
chemo-immunotherapy
survival
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: progression-free survival
timeFrame: 12 months after last patient entry
Secondary outcomes:
measure: 1-year overall survial
timeFrame: 12 months after last patient entry
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 within one year
timeFrame: 12 months after last patient entry
measure: 5-year overall survival
timeFrame: 5-years after last patient entry
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai jiaotong univestigy school of medicine
state: Shanghai
Study officials:
References: