Treatment for resectable non-small cell lung cancer using Sindilizumab and chemotherapy

A Randomized, Double-blind, Phase 3 Study of the Efficacy and Safety of Sindilizumab Combined With Chemotherapy or Placebo Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer (ORIENT-99)

This study is testing if adding Sindilizumab to chemotherapy can help people with resectable non-small cell lung cancer feel better and improve their treatment results compared to just chemotherapy with a placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry-sponsored)
• Drugs / interventions: Sindilizumab, chemotherapy
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05116462 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial is designed to evaluate the effectiveness and safety of Sindilizumab when combined with chemotherapy compared to a placebo with chemotherapy in patients with resectable Stage II to IIIB non-small cell lung cancer (NSCLC). Participants will be randomly assigned to receive either the treatment or placebo in a double-blind manner. The study aims to determine if this combination therapy can improve patient outcomes in terms of efficacy and safety. The trial will include patients who are eligible based on specific criteria related to their cancer stage and overall health.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with confirmed resectable Stage II, IIIA, or IIIB non-small cell lung cancer.

Not a fit: Patients with confirmed or suspected brain metastases or those currently participating in another interventional clinical study may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with resectable non-small cell lung cancer.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches in lung cancer, suggesting potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Subjects must sign the written informed consent form (ICF), and be able to follow the visits and relevant procedures specified in the protocol.
2. Age ≥ 18 years.
3. Cytologically or histologically confirmed primary NSCLC (including adenocarcinoma, squamous cell carcinoma).
4. Subjects with Stage II, IIIA or IIIB (resectable N2 only) disease based on the 8th edition of the TNM staging classification for lung cancer issued by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification (AJCC8).
5. Deemed radically resectable with curative intent.
6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
7. Have not received any prior systemic anti-tumor therapy or local radiotherapy for NSCLC.

Exclusion Criteria:

1. Subjects with confirmed or suspected brain metastases.
2. Currently participating in an interventional clinical study or treatment with another study drug or study device within 4 weeks prior to randomization.
3. Received Chinese herbal medicine, Chinese traditional medicine with anti-tumor indications, or drugs with immunomodulatory effects (including thymosin, interferon, interleukin) within two weeks prior to randomization
4. Received a live attenuated vaccine 4 weeks prior to randomization (or planned to receive a live attenuated vaccine during the study).
5. Requiring long term systemic corticosteroids
6. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive), known active syphilis.
7. Active hepatitis B.

Where this trial is running

Shanghai, Shanghai

• Shanghai Pulmonary Hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: chunxian Hu

Conditions Non-Small Cell Lung Cancer