NCT05116462Active, not recruitingPhase 3
Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer
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)
Source: ClinicalTrials.gov · Last updated 26 Jun 2025
Brief summary (registry, in English)
This study is a randomized, double-blind Phase 3 study to compare the efficacy and safety of Sindilizumab combined with chemotherapy or placebo combined with chemotherapy for neoadjuvant and adjuvant therapy for Resectable Stage II to IIIB (resectable N2 only) non-small cell lung cancer (NSCLC).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 506 (actual)
- First submitted
- 26 Oct 2021
- Start date
- 15 Mar 2024
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT05116462
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 506
- From 15 Mar 2024 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently participating in an interventional clinical study or treatment with another study drug or study device within 4 weeks prior to randomization.
- 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
- Received a live attenuated vaccine 4 weeks prior to randomization (or planned to receive a live attenuated vaccine during the study).
- Requiring long term systemic corticosteroids
Other illness
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive), known active syphilis.
- Active hepatitis B.
Other
- Subjects with confirmed or suspected brain metastases.
Who the study is looking for
- Subjects must sign the written informed consent form (ICF), and be able to follow the visits and relevant procedures specified in the protocol.
- Age ≥ 18 years.
- Cytologically or histologically confirmed primary NSCLC (including adenocarcinoma, squamous cell carcinoma).
- 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).
- Deemed radically resectable with curative intent.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Have not received any prior systemic anti-tumor therapy or local radiotherapy for NSCLC.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Pulmonary Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.