Clinical trial · Interventional
Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly And/or Frail Stage III Non-small-cell Lung Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer Stage III | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| decreased thoracic RT dose | Radiation | — | UNRESOLVED |
| standar thoracic RT dose | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- standar thoracic RT dose
- description
- Sequential chemo-immunotherapy plus standard dose of thoracic radiotherapy followed by anti-PD-1/PD-L1 maintenance therapy
- interventionNames
- Radiation: standar thoracic RT dose
- type
- EXPERIMENTAL
- label
- decreased thoracic RT dose
- description
- Sequential chemo-immunotherapy plus decreased thoracic radiotherapy followed by anti-PD-1/PD-L1 maintenance therapy
- interventionNames
- Radiation: decreased thoracic RT dose
Primary outcomes (1)
- measure
- progression-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDQi 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