Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly And/or Frail Stage III Non-small-cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: standar thoracic RT dose, decreased thoracic RT dose.
- Who it may be relevant to
- Registry conditions: Non-small Cell Lung Cancer Stage III. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Radiation 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. - Radiation 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.
Primary outcome measures
- progression-free survival [Time frame: 12 months after last patient entry]
Secondary outcome measures (3)
- 1-year overall survial [Time frame: 12 months after last patient entry]
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 within one year [Time frame: 12 months after last patient entry]
- 5-year overall survival [Time frame: 5-years after last patient entry]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Ruijin Hospital, Shanghai jiaotong univestigy school of medicine — Shanghai
Publications
- Qi WX, Li S, Wang M, Li H, Xu F, Yao L, Yu B, Chen L, Cai G, Xu C, Sun X, Bao Z, Chen J, Xiang Y, Zhao S. Sequential chemo-immunotherapy followed by standard versus reduced thoracic radiotherapy for older and/or frail stage III non-small-cell lung cancer: A randomized open-label cohort trial. PLoS Med. 2026 May 27;23(5):e1005111. doi: 10.1371/journal.pmed.1005111. eCollection 2026 May. PMID 42201929
Identifiers
NCT: NCT05557552 · 2021(189)