Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer

Phase 3Active Not RecruitingNCT05116462

Innovent Biologics (Suzhou) Co. Ltd.506 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

506

Conditions

Non-Small Cell Lung Cancer

Interventions

PemetrexedDRUG

500 mg/m2 D1 IV Q3W

CarboplatinDRUG

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

PaclitaxelDRUG

175 or 200 mg/m2 D1 IV Q3W

Sintilimab

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Event Free Survival (EFS) in stage III NSCLC

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

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

Event Free Survival (EFS) in ITT population

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

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

Secondary Outcomes

Disease free survival (DFS)

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

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

Major Pathological Response (mPR) Rat

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

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

Overall survival (OS)

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

Time frame: Up to approximately 5.4 years

Safety parameters:AE

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.

Data from ClinicalTrials.gov

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