Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly And/or Frail Stage III Non-small-cell Lung Cancer

NCT05557552 | Recruiting

• 1 other identifier: 2021(189)
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer Stage III

Keywords

thoradic radiotherapy; non-small-cell lung cancer; chemo-immunotherapy; survival

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  time from treatment start until death or progression of tumor disease within one year

  12 months after last patient entry

Secondary Outcomes (3)

• 1-year overall survial

  12 months after last patient entry

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 within one year

  12 months after last patient entry

• 5-year overall survival

  5-years after last patient entry

Study Arms (2)

standar thoracic RT dose

EXPERIMENTAL

Sequential chemo-immunotherapy plus standard dose of thoracic radiotherapy followed by anti-PD-1/PD-L1 maintenance therapy

Radiation: standar thoracic RT dose

decreased thoracic RT dose

EXPERIMENTAL

Sequential chemo-immunotherapy plus decreased thoracic radiotherapy followed by anti-PD-1/PD-L1 maintenance therapy

Radiation: decreased thoracic RT dose

Interventions

standar thoracic RT dose RADIATION

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.

standar thoracic RT dose

decreased thoracic RT dose RADIATION

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.

decreased thoracic RT dose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai jiaotong univestigy school of medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 28, 2022
• Study Start: September 30, 2022
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 23, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)