Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06837948 | Neoadjuvant Chemotherapy Combined With Bispecific Antibody Versus Monoclonal Antibody in Locally Advanced NSCLC | PHASE2 | NOT YET_RECRUITING | 160 | — | — | Feb 18, 2025 | Dec 1, 2031 | Feb 20, 2025 | 1 | China |
PCR rate is defined as the proportion of participants who have achieved pathologic complete response (on routine hematoxylin and eosin staining, no tumor cell can be found in tumor bed or lymph node) in all participants.
| Arm | Type | Description |
|---|---|---|
| Exploratory arm | EXPERIMENTAL | In this arm, 20 patients with locally advanced Non-small cell lung cancer will receive 4 circles of neoadjuvant PM8002 combined with platinum-based doublet chemotherapy and those resectable after neoadjuvant therapy will be treated with surgery. |
| PM8002 arm | EXPERIMENTAL | Patients with locally advanced Non-small cell lung cancer will be randomized into this arm (70 patients) and receive 4 circles of neoadjuvant PM8002 combined with platinum-based doublet chemotherapy and those resectable after neoadjuvant therapy will be treated with surgery. |
| Sintilimab arm | ACTIVE_COMPARATOR | Patients with locally advanced Non-small cell lung cancer will be randomized into this arm (70 patients) and receive 4 circles of neoadjuvant Sintilimab combined with platinum-based doublet chemotherapy and those resectable after neoadjuvant therapy will be treated with surgery. |
| Name | Type | Description |
|---|---|---|
| PM8002 | DRUG | Specified dose on specified days. |
| Sintilimab | DRUG | Specified dose on specified days. |
| Nab-paclitaxel | DRUG | Specified dose on specified days. |
| Carboplatin | DRUG | Specified dose on specified days. |
| Surgery | PROCEDURE | Patients with resectable tumor after neoadjuvant therapy will be treated with surgery. |
Inclusion Criteria: 1. The patient shall sign the Informed Consent Form. 2. Aged 18 ≥ years. 3. Histological or cytological diagnosis of NSCLC by needle biopsy, and stage II-III confirmed by imageological examinations (CT, PET-CT or EBUS)，and have not previously received anti-tumor treatment. 4. Ea...