The Efficacy and Safety of the Bispecific Anti-PD-1/PD-L1 Antibody IBI318 Combined with Lenvatinib in NSCLC.

Required: EGFR sensitizing mutation

without EGFR gene sensitive mutations

Required: ALK fusion

without ... ALK gene fusion

Required: ROS1 fusion

without ... ROS1 gene fusion

Required: EGFR sensitizing mutation

with histologically confirmed EGFR-sensitive mutations

Required: ALK fusion

with ... ALK fusion

Required: EGFR T790M

There is no T790M mutation in 20 exon after the failure of previous one or two generations of EGFR-TKI

Required: EGFR T790M

The 20 exon T790M mutation occurred after the treatment failure of the first or second generation EGFR-TKI monotherapy

Required: EGFR T790M

Failure of prior osimertinib or other third-generation EGFR-TKI therapy as first-line therapy (regardless of EGFR T790M mutation status)

Required: PD-L1 (CD274) wild-type (TPS <1% (22C3 test))

negative for PD-L1 expression. Negative expression of PD-L1 was defined as TPS <1% using 22C3 test.

Must have received: anti-PD-1 therapy — first-line, advanced stage

Relapse after failure of first-line anti-PD-1 /PD-L1 antibody therapy

Must have received: EGFR tyrosine kinase inhibitor (gefitinib, erlotinib, icotinib, afatinib, osimertinib)

Relapse after failure of anti-EGFR-TKI ... therapy

Must have received: ALK inhibitor

disease progression should occur after adequate ALK-TKI treatment

Cannot have received: lenvatinib (lenvatinib)

Previously received lenvatinib

Cannot have received: bevacizumab (bevacizumab)

Previously received ... bevacizumab

Cannot have received: anlotinib (anlotinib)

Previously received ... anlotinib

Cannot have received: anti-PD-1/PD-L1 therapy

Exception: Cohort B and C only

To cohort B and C: Prior treatment: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulating or co-inhibiting T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.)

Cannot have received: anti-PD-1/PD-L1 therapy

Exception: Cohort A only if toxicity caused permanent discontinuation or not recovered to grade 0-1

To cohort A: subjects who have previously used anti-PD-1, PD-L1 or other immunotherapy and meet the following conditions: The toxicity that caused permanent discontinuation occurred before the termination of immunotherapy; Prior to the administration of the study drug, the toxicity of the previous immunotherapy has not recovered or has not recovered to level 0-1.

Cannot have received: systemic anti-tumor therapy

Received systemic anti-tumor therapy within 2 weeks before treatment, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal medicine with anti-tumor indications), etc.

Cannot have received: investigational drug

Have received any investigational drug treatment within 4 weeks before treatment