SinTilimab After Radiation (STAR Study)

Carcinoma, Non-Small Cell Lung Clinical Trial

— STAR  

Official title:

A Phase II Single-arm Study of Sintilimab After Thoracic Radiation in Previously Treated Advanced NSCLC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04167657
• Other study ID #: HS-1856
• Status: Recruiting
• Phase: Phase 2
• Start date: April 15, 2019
• Est. completion date: April 15, 2023

Study information

• Verified date: November 2019
• Source: Peking Union Medical College Hospital
• Contact: Yan Xu, M.D.
• Phone: 861069155154
• Email: maraxu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-arm phase II study, to investigator the efficacy and safety of sintilimab after radiation in advanced NSCLC, who had failed first line systemic therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: April 15, 2023
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Signed written informed consent;

2. Age = 18 years ;

3. Histologically or cytologically confirmed NSCLC, without EGFR sensitive mutation (must) or no known ALK/ROS1 positive;

4. Stage IIIB-IV (AJCC 8th edition) or recurrent/progressive disease after multidisciplinary treatment for local advanced disease;

5. Patients must have disease progression or recurrence after receiving first line systemic therapy for advanced or metastasis disease: 1) Maintenance therapy after platinum based chemo-doublet shall not be considered as a separated treatment regimen, 2)Patients who had received neo-adjuvant/adjuvant therapy or radical chemo- radiotherapy for local advanced disease and relapsed after 6 month or later, must have failed first line treatment for recurrent disease before enrollment;

6. ECOG PS 0-1, with expected survival over 3 months;

7. Patients shall have at least one leision eligible for radiation, e.g. bone metastasis, intrapulmonary node, adrenal disease, etc. Patient must have at least one disease (other than radiation target) according to RECIST 1.1: 1) Patient must have received radiation for 1 location after disease progression or recurrence after first line treatment for advanced or metastasis disease, 2) Time between first dose of sintilimab and last radiation shall be no longer than 3 weeks

8. Adequate marrow and organ function as per baseline CBC/CMP/Urine test;

9. Prior anti-tumor therapy should be completed at least 4 weeks before enrollment, and adverse events of prior treatment shall be return to =G1 per CTCAE (except for alopecic or any non-clinical significant laboratory abnormalities) ;

10. Women with childbearing potential or men whose female partners are with childbearing potential must agree to use efficient contraceptive methods during the study treatment period until 90 days after last dose of study treatment.

Exclusion Criteria:

1. Previously treated by any immune therapy;

2. Active infection including HBV, HCV, and HIV;

3. Serious marrow or organ malfunction, e.g. hepatic or renal dysfunction;

4. Patients with unstable CNS metastasis or require corticosteroids to control CNS symptoms. Patients with stable brain metastasis after radiation (3 weeks) will be eligible;

5. Active or autoimmune disease;

6. ILD, including drug-induced ILD, radiation pneumonia that required corticosteroids, or any clinical implication for active ILD;

7. Any course that lead to treatment with continuous systemic corticosteroids >10 mg/day prednisone or equivalent dose of other steroids;

8. Pregnant or lactating women.

Related Conditions & MeSH terms

• Carcinoma, Non-Small Cell Lung
• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Sintilimab
Sintilimab 200mg IV, every 3 weeks, until progressive disease (PD), intolerable toxicity, or at a maximum of 12 months. Before enrollment, patient should undergo radiation no less than dose 30Gy/5f. Sintilimab shall be started no later than 3 weeks after radiation.

Locations

Country	Name	City	State
China	Department of Respiratory Medicine, Peking Union Medical College Hospita	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	ORR (per RECIST 1.1 as assessed by the investigator) is defined as the proportion of patients with a complete response (CR) or partial response (PR) as their best respons ORR (per RECIST 1.1 as assessed by the investigator) is defined as the proportion of patients with a complete response (CR) or partial response (PR) as their best respons	Time Frame: up to 12 months after enrollment or study close