RecruitingNot ApplicableNCT05557552

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

Sponsor

Ruijin Hospital

Enrollment

56 participants

Start Date

Sep 30, 2022

Study Type

INTERVENTIONAL

Conditions

Non-Small Cell Lung Cancer (Stage III)

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment approach for older or frail patients with advanced (stage III) non-small cell lung cancer who are not strong enough to receive standard concurrent chemoradiation. The approach involves giving chemotherapy and immunotherapy first, then following up with radiation. **You may be eligible if:** - You are 18 or older and have been diagnosed with unresectable stage III non-small cell lung cancer (NSCLC) - You are not fit for standard concurrent chemoradiation due to age (70+), reduced function (ECOG 2), or other health factors - You have adequate blood, liver, kidney, and lung function - Your cancer is measurable and can be safely irradiated - Your life expectancy is at least 3 months **You may NOT be eligible if:** - You have previously received chemotherapy, immunotherapy, or radiation for lung cancer - You had major surgery in the last 28 days - You have had an organ transplant, autoimmune disease, or active hepatitis or HIV - You are pregnant or breastfeeding - You are taking immunosuppressive medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONstandar 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.

RADIATIONdecreased 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.