Non-Small Cell Lung Cancer
Conditions
Brief 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).
Interventions
DRUGPemetrexed
500 mg/m2 D1 IV Q3W
DRUGCarboplatin
AUC 5 or 6 mg/ml/min D1 IV Q3W
DRUGPaclitaxel
175 or 200 mg/m2 D1 IV Q3W
DRUGSintilimab
200 mg D1 IV Q3W
DRUGCisplatin
75 mg/m2 D1 IV Q3W
DRUGNab paclitaxel
100 mg/m2 D1, 8, 15 IV Q3W
DRUGPlacebo
20 ml D1 IV Q3W
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 ) | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival (DFS) | 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. |
| Major Pathological Response (mPR) Rat | 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. |
| Overall survival (OS) | Up to approximately 5.4 years | OS is defined as the time from randomization to death due to any cause. |
| Safety parameters:AE | 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. |
Countries
China
Outcome results
None listed