Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is a randomized, controlled, multicenter, open-label study, planning to enroll 116 subjects with resectable stage II-IIIa squamous NSCLC confirmed by histopathology or cytology, aiming to evaluate the efficacy and safety of serplulimab compared to nivolumab combined with chemotherapy in neoadjuvant therapy. This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1036.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serplulimab + chemotherapy | Experimental | Serplulimab injection [300 mg, administered on Day 1, Q3W (once every 3 weeks)] + paclitaxel (albumin-bound) for injection [260 mg/m2, highest dose Not More Than 400 mg, administered on Day 1, Q3W] + carboplatin injection (AUC=5, highest dose Not More Than 750 mg, administered on Day 1, Q3W) for 2-3 cycles; |
|
| Nivolumab + chemotherapy | Active Comparator | Nivolumab [360 mg, administered on Day 1, Q3W (once every 3 weeks)] + paclitaxel (albumin-bound) for injection [260 mg/m2, highest dose Not More Than 400 mg, administered on Day 1, Q3W] + carboplatin injection (AUC=5, highest dose Not More Than 750 mg, administered on Day 1, Q3W) for 2-3 cycles; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serplulimab + chemotherapy | Drug | Serplulimab injection [300 mg, administered on Day 1, Q3W (once every 3 weeks)] + paclitaxel (albumin-bound) for injection [260 mg/m2, highest dose Not More Than 400 mg, administered on Day 1, Q3W] + carboplatin injection (AUC=5, highest dose Not More Than 750 mg, administered on Day 1, Q3W) for 2-3 cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete remission (PCR) rate | Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by investigator. | From randomization up to a median of 30 months after randomization |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Nivolumab + chemotherapy | Drug | Nivolumab [360 mg, administered on Day 1, Q3W (once every 3 weeks)] + paclitaxel (albumin-bound) for injection [260 mg/m2, highest dose Not More Than 400 mg, administered on Day 1, Q3W] + carboplatin injection (AUC=5, highest dose Not More Than 750 mg, administered on Day 1, Q3W) for 2-3 cycles; |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007136 |
| Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |