Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Low-dose radiation and stereotactic body radiation therapy combined with PD-1 inhibitor (sintilimab) and chemotherapy versus PD-1 inhibitor combined with chemotherapy as first-line treatment for patients with locally advanced or metastatic squamous cell lung cancer: a randomized phase II multicenter clinical trial
Excerpt:...Provide sufficient quality control qualified tumor tissue or cell wax blocks to detect PD-L1 expression (TPS, antibody E1L3N);...
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Phase II Trial: Low-Dose Radiation + SBRT + Sintilimab + Chemotherapy vs. Sintilimab + Chemotherapy in Advanced Squamous Cell Lung Cancer
Excerpt:...Enough to provide quality control qualified tumor tissue or cell wax blocks to detect PD-L1 expression; 5....
More C2 evidence

Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
A Phase II Study of Anti-PD-1 Antibody, Sintilimab, as Second-line Therapy for Biomarker-selected Advanced or Metastatic NSCLC
Excerpt:...- NSCLC that is anti-programmed cell death ligand 1 (PD-L1) positive(TPS PD-L1 expression is ≥1% ), and CD8 expression is ≥20% (pre-treatment samples are sufficient)....
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Sintilimab (IBI308) in the Neoadjuvant Treatment of Patients With Resectable II-IIIA NSCLC
Excerpt:...PD-L1 expression level ≥ 1%; 8....
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Efficacy and safety of intrapleural administration of sintilimab in advanced non-small cell lung cancer patients with malignant pleural effusion: a prospective multi-center study
Excerpt:...Rate of pleural atresia at Week 5; Rate of pleural atresia at Week 10; Safety of intrapleural administration of sintilimab; Disease control of extrathoracic lesion; PD-L1 expression in pleural fluid clotting; PD-L1 expression on pleural fluid circulating tumor cells;...
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
The efficacy and safety of chemotherapy with Tafolecimab and Sintilimab in advanced or metastatic driver-gene-negative non-small cell lung cancer after first-line immunotherapy failure: a prospective, single arm phase II clinical study.tive non-small cell lung cancer patients after first-line immunotherapy failure
Excerpt:...Progression free Survival, PFS; The time from the start of treatment to the first imaging of disease progression or death (whichever occurs first); The time of the first imaging of disease progression or death; Objective response rate, ORR; Disease control rates,DCR; Duration of Response,DOR; Overall survival,OS; Safety evaluation; Exploratory indicators; The proportion of subjects who achieved complete response (CR) and partial response (PR) to the total number of subjects; The proportion of subjects with CR, PR, and SD among the total subjects; The time interval from disease remission to disease progression or death (whichever occurs first); Defined as the time from the start of treatment to the death of the subject for any reason.; Evaluation according to CTCAE 5.0; 1) Evaluation of iORR, iPFS, iDCR, and iDOR according to iRECIST; 2) Potential biomarkers for predicting the efficacy of chemotherapy with Tafolecimab and Sintilimab, including but not limited to PD-L1 expression and TMB levels in tumor tissue specimens.; Time of best effect; Time of best effect; The time of the first imaging of disease progression or death; Death; After the start of treatment; After the start of treatment...
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
A Single-Arm, Single-Center, Prospective Phase II Clinical Study of Stephania Longa and Jiezai Rice Combined with Sintilimab in Advanced Driver Gene-Negative, PD-L1-Positive NSCLC Patients Who Failed First-Line Immunotherapy
Less C2 evidence

Evidence Level:Sensitive: C3 – Early Trials
Title:
Safety and Tolerability of Low-Dose Radiation and Stereotactic Body Radiotherapy + Sintilimab for Treatment-Naive Stage IV PD-L1+ Non-Small-Cell Lung Cancer Patients
Excerpt:The findings indicate that the novel SBRT + LDRT + sintilimab therapy is safe and promising in patients with PD-L1-positive, driver gene-negative primary metastatic NSCLC.
DOI:10.1158/1078-0432.CCR-23-0315