Overview
This is a multiple-arm, open phase II clinical trial evaluating the safety, tolerability,and preliminary efficacy of JS207 in NSCLC after progression following Platinum-based chemotherapy and immunotherapy.
Eligibility
Inclusion Criteria:
- Histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) NSCLC that is not amenable to radical surgery or radical radiochemotherapy, or Metastatic or recurrent NSCLC.
- Patients with incurable locally advanced or metastatic or recurrent NSCLC who have experienced treatment failure with first-line treatment using a PD-1/PD-L1 inhibitor combined with platinum-based doublet chemotherapy (except docetaxel) or treatment failure with sequential first-line treatment using a PD-1/PD-L1 inhibitor and platinum-based doublet chemotherapy (except docetaxel) may be eligible. Previous treatments include anti-VEGF monoclonal antibody. For patients with operable early stage or locally advanced NSCLC who have received adjuvant and/or neoadjuvant therapy, radical radiotherapy or radiochemotherapy, disease progression or recurrence within 6 months after the last anti-tumor therapy, adjuvant/neoadjuvant/radiochemotherapy is considered as first-line therapy.
- Subjects must have at least one measurable lesion according to RECIST v1.1.
Exclusion Criteria:
- Histopathologically or cytopathologically confirmed to have combined neuroendocrine (including small cell lung cancer, large cell neuroendocrine carcinoma, etc.) component.
- Sensitivity mutation of EGFR or ALK fusion; known ROS1 fusion, BRAF V600E mutation, MET 14 exon skip mutation, RET fusion, etc. Gene mutation. The EGFR and ALK fusion status must be tested in patients with non-squamous cell carcinoma (the mutation status must be confirmed based on the tissue test if the blood test is negative); the genetic test is not mandatory for patients with squamous cell carcinoma.
- Tumor encircles important blood vessels or has obvious necrosis and air space, and the investigator considers that it may cause hemorrhage risk.