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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sintilimab | Experimental | Neoadjuvant Treatment period: up to 3 cycles of sintilimab plus platinum-based chemotherapy prior to surgery. adjuvant Treatment period: Subjects will receive 1 cycle of sintilimab plus platinum-based chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles. |
|
| Placebo | Placebo Comparator | Neoadjuvant Treatment period: up to 3 cycles of placebo plus platinum-based chemotherapy prior to surgery. adjuvant Treatment period: Subjects will receive 1 cycle of placebo plus platinum-based chemotherapy, and then receive placebo therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemetrexed | Drug | 500 mg/m2 D1 IV Q3W |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | EFS is defined as the time from randomization to the first recorded time to any first documented progression, recurrence or death, which occurs first. | Up to approximately 3 years following the beginning of Post-operative Assessment baseline(up to Study 3 years ) |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival (DFS) | DFS is defined as the time from surgery to disease recurrence or death due to any cause. | Up to approximately 2 years following the begining of Post-operative Assessment baseline(up to Study 5.4 years ) |
| Major Pathological Response (mPR) Rat |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | 200433 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| C000632826 | sintilimab |
| D002945 | Cisplatin |
| D013660 | Taxes |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| 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 |
|
mPR rate is defined as ≤ 10% residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy. |
| 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. | 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. | Up to approximately 5.4 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |