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

Non-small Cell Lung Cancer Stage III Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05557552
• Other study ID #: 2021(189)
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2022
• Est. completion date: September 30, 2026

Study information

• Verified date: November 2023
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer Stage III

Intervention

Radiation:
• standar 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 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.
• decreased 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 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.

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai jiaotong univestigy school of medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival	time from treatment start until death or progression of tumor disease within one year	12 months after last patient entry
Secondary	1-year overall survial	time from treatment start until death with in one year	12 months after last patient entry
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 within one year	Safety and Tolerability	12 months after last patient entry
Secondary	5-year overall survival	Time from treatment start until death	5-years after last patient entry