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

Inclusion Criteria9

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 Criteria8

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

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.