The goal of this clinical trial is to evaluate the efficacy and safety of albumin-bound paclitaxel-lenvatinib-pembrolizumab in advanced nonsquamous NSCLC patients after progression to first-line anti-PD-1/L1 inhibitor with platinum-doublet chemotherapy. All participants will be given with albumin-bound paclitaxel, lenvatinib and pembrolizumab.
Male/female participants who are at least 18 years of age on the day of signing informed consent (ICF) with histologically confirmed diagnosis of metastatic nonsquamous NSCLC (AJCC Staging Manual, Version 8) will be enrolled in this study.
Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Have confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy. Subjects who have failed directed therapy are not eligible for the study.
The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment initiation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Has received prior therapy at any stage of disease with any anti-VEGF-TKIs (i.e. Bevacizumab, Lenvatinib, Anlotinib, Apatinib, etc.) as monotherapy or in combination with an anti-PD-1/L1 inhibitor.
Has received prior Paclitaxel, Docetaxel or Albumin-paclitaxel as monotherapy or in combination with other therapies at any stage of disease.
Has received prior radiotherapy within 2 weeks of start of study intervention or has received lung radiation therapy >30 Gy within 6 months before the first dose of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
Single group
pembrolizumab
Drugpembrolizumab 200mg IV on day 1 for every 3 weeks
lenvatinib
Druglenvatinib 8mg taken orally every day
albumin-bound paclitaxel
Drugalbumin-bound paclitaxel IV 100mg/m2 D1, 8 every 3 weeks
Objective response rate
Objective response rate (ORR) assessed per the Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
Overall survival
Overall survival (OS)
Progression-free survival
Progression-free survival (PFS) assessed per RECIST v1.1
Duration of response
Duration of response (DoR) assessed per RECIST v1.1
Treatment-related adverse events
Treatment-related adverse events (TRAEs) assessed by CTCAE v5.0
Single cell sequencing of tumor specimens
Tumor specimens were collected before and after treatment for single cell assays to assess changes in the tumor immune microenvironment
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Peking University First Hospital
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
