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Anlotinib · 1 trial · 1 indication
pCR is defined as the absence of residual viable tumor cells in the primary lung tumor and all sampled regional lymph nodes upon systematic pathological review of the surgical specimen, per the IASLC 2020 pathological evaluation criteria. The treatment-escalation population comprises patients with ctDNA non-clearance and radiological stable disease (SD) after two cycles of neoadjuvant therapy.
| Arm | Type | Description |
|---|---|---|
| ctDNA-MRD and imaging-guided dynamic neoadjuvant therapy | EXPERIMENTAL | All participants initially receive two 21-day cycles of one PD-1 inhibitor (nivolumab, pembrolizumab, toripalimab, or tislelizumab) plus platinum-based doublet chemotherapy (nab-paclitaxel/carboplatin for squamous; pemetrexed/carboplatin for non-squamous histology). After two cycles, ctDNA-MRD testing and radiological assessment (RECIST 1.1) guide treatment: patients with ctDNA non-clearance and stable disease receive an intensified four-drug regimen (PD-1 inhibitor + anlotinib + nab-paclitaxel + carboplatin) for cycles 3-4, non-squamous patients switching from pemetrexed to nab-paclitaxel; all others (ctDNA clearance, or CR/PR) continue the original regimen. Upon completion of neoadjuvant therapy, patients deemed resectable by a multidisciplinary team undergo definitive surgery. |
| Name | Type | Description |
|---|---|---|
| PD-1 inhibitor | DRUG | One of four PD-1 inhibitors selected per patient: nivolumab 360 mg, pembrolizumab 200 mg, toripalimab 240 mg, or tislelizumab 200 mg, administered by intravenous infusion once every 3 weeks |
| Carboplatin | DRUG | AUC 5 by intravenous infusion on day 1 of each 21-day cycle |
| Nab-paclitaxel | DRUG | 100 mg/m² by intravenous infusion on days 1 and 5 of each 21-day cycle. Used for squamous histology throughout all cycles, and for non-squamous histology in the treatment-escalation group (cycles 3-4), where it replaces pemetrexed |
| Pemetrexed | DRUG | 500 mg/m² by intravenous infusion on day 1 of each 21-day cycle (non-squamous histology). In the treatment-escalation group, pemetrexed is replaced by nab-paclitaxel during cycles 3-4 |
| Anlotinib | DRUG | 12 mg orally once daily on days 1-14 of each 21-day cycle; added during cycles 3-4 in the treatment-escalation group |
Inclusion Criteria: 1. Voluntary participation with signed informed consent. 2. Previously untreated, histologically confirmed, resectable or borderline resectable stage II-IIIA or IIIB (N2) non-small cell lung cancer, per the 8th edition AJCC staging. 3. Negative for EGFR and ALK driver alteration...