Phase II Clinical Trial to Evaluate the Safety and Efficacy of TQB2450 Injection Combined With Anlotinib Capsule and Chemotherapy in the Treatment of Immunoresistant Advanced Non-small Cell Lung Cancer

Required: EGFR sensitizing mutation

Except for patients with squamous NSCLC, enrolled patients need to demonstrate the absence of EGFR gene sensitive mutations, ALK fusion oncogenes, or ROS1 fusion oncogenes

Required: EGFR wild-type

enrolled patients need to demonstrate the absence of EGFR gene sensitive mutations

Required: ALK wild-type

enrolled patients need to demonstrate the absence of ... ALK fusion oncogenes

Required: ROS1 wild-type

enrolled patients need to demonstrate the absence of ... ROS1 fusion oncogenes

Required: PD-L1 (CD274) expression (testing required; no eligibility threshold specified)

at least 5 samples are required for PD-L1 testing of tumor tissue

Must have received: checkpoint inhibitor (PD-1 monoclonal antibody, PD-L1 monoclonal antibody, dual antibodies) — first-line

Tumor resistance has progressed after receiving first-line treatment with immune checkpoint inhibitors (including PD-1 or PD-L1 monoclonal or dual antibodies) combined with platinum based drugs in the past

Must have received: platinum-based chemotherapy — first-line (in combination with checkpoint inhibitor)

Tumor resistance has progressed after receiving first-line treatment with immune checkpoint inhibitors (including PD-1 or PD-L1 monoclonal or dual antibodies) combined with platinum based drugs in the past

Cannot have received: anti-angiogenic drug (arotinib, apatinib, lenvatinib, sorafenib, sunitinib, regofinib, furoquitinib)

previously used anti angiogenic drug systems such as arotinib, apatinib, lenvatinib, sorafenib, sunitinib, regofinib, and furoquitinib to treat locally advanced or metastatic NSCLC

Cannot have received: taxane (docetaxel)

Previously received docetaxel for systematic treatment of locally advanced or metastatic NSCLC

Cannot have received: immunomodulatory agent

Patients who have received medication with immunomodulatory effects within 30 days before starting treatment

Cannot have received: systemic corticosteroid (prednisone)

Exception: ≤ 14 days, >10 mg/d or equivalent

any symptoms that require systemic treatment with corticosteroids (prednisone or equivalent doses of similar drugs above 10 mg/d) or other immunosuppressive agents for ≤ 14 days

Cannot have received: traditional Chinese patent medicines and simple preparations with anti-tumor indications

received traditional Chinese patent medicines and simple preparations with anti-tumor indications specified in the NMPA approved drug instructions within 2 weeks before the start of the study treatment