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

NCT05557552 · tracked via the Priya Life Science China tracker

Sponsor

Ruijin Hospital

Phase

Not applicable

Started

2022-09-30

Last updated

2024-09-23

Condition(s) studied

Non-small Cell Lung Cancer Stage III

Investigational drug(s) / intervention(s)

standar thoracic RT dosedecreased thoracic RT dose

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 4-6 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.

decreased 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 4-6 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.

Study 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

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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 outcome measure(s)

progression-free survival — 12 months after last patient entry
time from treatment start until death or progression of tumor disease within one year

Trial sites (1)

Facility	City	Region	Status
Ruijin Hospital, Shanghai jiaotong univestigy school of medicine	Shanghai	Shanghai Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05557552 on ClinicalTrials.gov ↗ ← All trials in China