NCT05557552 Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly And/or Frail Stage III Non-small-cell Lung Cancer
| NCT ID | NCT05557552 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ruijin Hospital |
| Condition | Non-small Cell Lung Cancer Stage III |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2022-09-30 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 56 participants in total. It began in 2022-09-30 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Frequently Asked Questions
Who can join the NCT05557552 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Non-small Cell Lung Cancer Stage III. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05557552 currently recruiting?
Yes, NCT05557552 is actively recruiting participants. Visit ClinicalTrials.gov or contact Ruijin Hospital to inquire about joining.
Where is the NCT05557552 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05557552 clinical trial?
NCT05557552 is sponsored by Ruijin Hospital. The trial plans to enroll 56 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.