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

NCT ID: NCT05557552

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2026-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

standar thoracic RT dose

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

Group Type: EXPERIMENTAL

standar thoracic RT dose

Intervention Type: 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.

decreased thoracic RT dose

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

Group Type: EXPERIMENTAL

decreased thoracic RT dose

Intervention Type: 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.

Interventions

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 4-6 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.

Intervention Type: RADIATION

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 4-6 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.

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shengguang Zhao

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ruijin Hospital, Shanghai jiaotong univestigy school of medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yifeng Wang

Role: primary

qwx12055@rjh.com.cn

+862164370045

Yi Xiang, Dr.

Role: backup

Shengguang Zhao, Dr

Role: backup

Other Identifiers

2021(189)

Identifier Type: -

Identifier Source: org_study_id