Chemo-immunotherapy and Radiotherapy for Elderly Patients with Stage III 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
This study is testing a new treatment combining chemotherapy, immunotherapy, and radiation for older patients with stage III lung cancer to see if it is safer and more effective than the usual treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | durvalumab, chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05557552 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and safety of sequential chemo-immunotherapy combined with thoracic radiotherapy specifically for elderly and/or frail patients diagnosed with unresectable stage III non-small-cell lung cancer (NSCLC). The approach aims to provide an alternative to the standard concurrent chemoradiotherapy, which may be too toxic for patients with poor performance status or significant comorbidities. The study will evaluate different doses of thoracic radiotherapy to determine the optimal treatment for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 70 and above or those with a poor performance status who are unfit for standard concurrent chemoradiotherapy.
Not a fit: Patients who have previously undergone chemotherapy, immunotherapy, or radiotherapy for NSCLC may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a safer and more effective treatment option for elderly and frail patients with stage III NSCLC.
How similar studies have performed: While the standard PACIFIC regimen has shown success, this specific approach for frail and elderly patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality
- Ruijin Hospital, Shanghai jiaotong univestigy school of medicine — Shanghai, Shanghai Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.