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NCT Number: NCT05116462

Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Subjects with confirmed or suspected brain metastases.
  • 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
  • Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive), known active syphilis.
  • Active hepatitis B.

Treatment and study plan

Pemetrexed

Drug

500 mg/m2 D1 IV Q3W

carboplatin

Drug

AUC 5 or 6 mg/ml/min D1 IV Q3W

paclitaxel

Drug

175 or 200 mg/m2 D1 IV Q3W

Sintilimab

Drug

200 mg D1 IV Q3W

Cisplatin

Drug

75 mg/m2 D1 IV Q3W

Nab paclitaxel

Drug

100 mg/m2 D1, 8, 15 IV Q3W

Placebo

Drug

20 ml D1 IV Q3W

Primary outcomes

  1. Event Free Survival (EFS) in stage III NSCLC

    Time frame: Up to approximately 2 years following the beginning of Post-operative Assessment baseline(up to Study 2 years )

    Up to approximately 2 years following the beginning of Post-operative Assessment baseline(up to Study 2 years )

  2. Event Free Survival (EFS) in ITT population

    Time frame: Up to approximately 3 years following the beginning of Post-operative Assessment baseline(up to Study 3 years )

    EFS is defined as the time from randomization to the first recorded time to any first documented progression, recurrence or death, which occurs first.

Secondary outcomes

  1. Disease free survival (DFS)

    Time frame: Up to approximately 2 years following the begining of Post-operative Assessment baseline(up to Study 5.4 years )

    DFS is defined as the time from surgery to disease recurrence or death due to any cause.

  2. Major Pathological Response (mPR) Rat

    Time frame: Up to approximately 6 weeks following completion of neoadjuvant treatment (up to Study 2 years)

    mPR rate is defined as ≤ 10% residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy.

  3. Overall survival (OS)

    Time frame: Up to approximately 5.4 years

    OS is defined as the time from randomization to death due to any cause.

  4. Safety parameters:AE

    Time frame: Up to approximately 5.4 years

    The relationship of study drug and the severity of all adverse events (AEs), treatment emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), immune-related adverse events (irAEs), serious adverse events (SAEs), infusion-related reactions (IRRs) and surgery delay rate.

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

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)

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Nov 11, 2021
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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