SinTilimab After Radiation (STAR Study)

NCT04167657 | Completed Phase 2

• 1 other identifier: HS-1856
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-arm multi-center phase II clinical study, which aims to investigate the efficacy and safety of sintilimab after radiotherapy in patients with advanced NSCLC who failed first-line or second-line systemic treatment.

Conditions

Carcinoma, Non-Small Cell Lung

Keywords

Advanced non-small cell lung cancer; Immunotherapy; Radiation; PD-1; Sintilimab

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Arm1

EXPERIMENTAL

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.

Drug: Sintilimab

Interventions

Sintilimab DRUG

Sintilimab 200mg IV, every 3 weeks, until progressive disease (PD), intolerable toxicity, or at a maximum of 24 months. Before enrollment, patient should undergo radiation no less than dose 30Gy( 6 Gy × 5, or other ), or the planned dose could reach 30 Gy. Sintilimab shall be started no later than 3 weeks after radiation. Radiotherapy can be performed on the same day as sintilimab.

Arm1

Eligibility Criteria

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

You may qualify if:

• Signed written informed consent;
• Age ≥ 18 years ;
• Histologically or cytologically confirmed NSCLC, without EGFR sensitive mutation (must) or no known ALK/ROS1 positive;
• Stage IIIB-IV (AJCC 8th edition) or recurrent/progressive disease after multidisciplinary treatment for local advanced disease or chemotherapy intolerant patients;
• ECOG PS 0-1, with expected survival over 3 months;
• 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, the biological dose of a single site of radiotherapy is required to exceed 30 Gy ( 6 Gy × 5, or other ) or the plan can reach 30 Gy. 2) Radiotherapy can be performed on the same day as Sindilizumab, but the last radiotherapy is no more than 3 weeks after the start of Sindilizumab treatment.
• Adequate marrow and organ function as per baseline CBC/CMP/Urine test;
• Prior systemic 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) ;
• 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.

You may not qualify if:

• Previously treated by any immune therapy;
• Active infection including HBV, HCV, and HIV;
• Serious marrow or organ malfunction, e.g. hepatic or renal dysfunction;
• Patients with unstable CNS metastasis or require corticosteroids to control CNS symptoms. Patients with stable brain metastasis after radiation (3 weeks) will be eligible;
• Active or autoimmune disease;
• ILD, including drug-induced ILD, radiation pneumonia that required corticosteroids, or any clinical implication for active ILD;
• Any course that lead to treatment with continuous systemic corticosteroids \>10 mg/day prednisone or equivalent dose of other steroids;
• Pregnant or lactating women.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Department of Respiratory Medicine, Peking Union Medical College Hospita

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sintilimab

Condition Hierarchy (Ancestors)

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

Study Officials

• Mengzhao Wang, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 19, 2019
• Study Start: April 15, 2019
• Primary Completion: November 30, 2023
• Study Completion: April 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)