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Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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)

NCT05116462•Innovent Biologics (Suzhou) Co. Ltd.

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

March 15, 2024

Primary Completion Date

September 30, 2026

Completion Date

October 14, 2028

Last Updated

June 26, 2025

Enrollment

506

ACTUAL participants

Conditions

Non-Small Cell Lung Cancer

Interventions

Pemetrexed

DRUG

Carboplatin

DRUG

Paclitaxel

DRUG

Sintilimab

DRUG

Cisplatin

DRUG

Nab paclitaxel

DRUG

Placebo

DRUG

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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RECRUITINGPHASE3

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)