SinTilimab After Radiation (STAR Study)

Phase 2

• Conditions: Carcinoma, Non-Small Cell Lung
• Interventions: Drug: Sintilimab

• Registration Number: NCT04167657
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-15
• Status Verified: 2019-11
• Study First Submitted: 2019-11-15
• Study First Submitted QC: 2019-11-15
• Last Update Submitted: 2019-11-15
• Study First Posted: 2019-11-19
• Last Update Posted: 2019-11-19
• Primary Completion: 2022-04-15
• Study Completion: 2023-04-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 37

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm1	Sintilimab	Sintilimab monotherapy every 3 weeks, after a radiation targeting a single location no less than dose 30Gy( 6 Gy × 5, or other ), or the planned dose could reach 30 Gy.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Time Frame: up to 12 months after enrollment or study close	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

Trial Locations

Locations (1)

Department of Respiratory Medicine, Peking Union Medical College Hospita; 🇨🇳 Beijing, Beijing, China