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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2026
  • participants needed
    56
  • sponsor
    Ruijin Hospital
Updated on 14 October 2022

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.

Details
Condition Non-small Cell Lung Cancer Stage III
Treatment standar thoracic RT dose, decreased thoracic RT dose
Clinical Study IdentifierNCT05557552
SponsorRuijin Hospital
Last Modified on14 October 2022

Eligibility

Yes No Not Sure

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
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