Abstract
Background
There is an urgent and unmet need for more effective treatment options for patients
with metastatic and recurrent non–small-cell lung cancer (NSCLC) who progressed on
platinum-based therapy, immune checkpoint inhibitors (ICI), and targeted therapies.
Currently, the combination of docetaxel (D) and ramucirumab (R) is the next best salvage
therapy with a modest historical progression free survival (PFS) of 4.5 months and
6-month PFS rate of 37% predating the era of ICI use. Anecdotal reports in patients
who progressed on ICI suggest a higher response rate to docetaxel compared to historical
experience. Furthermore, tumor related angiogenesis promotes tumor growth and may
contribute to immune escape in patients treated with ICI. Therapeutic combination
with anti-angiogenic, ICI, and chemotherapy have independently demonstrated clinical
efficacy without additive toxicities in NSCLC patients.
Patients and methods
This multicenter, single arm, open label, phase 2 study will evaluate the safety and
preliminary efficacy of the combination of docetaxel 75 mg/m2, ramucirumab 10 mg/kg, and pembrolizumab 200 mg in up to 41 patients with metastatic
or recurrent NSCLC after progression on concomitant or sequential platinum-based chemotherapy
and ICI. This treatment will be given intravenously on the same day every 3 weeks
until disease progression, occurrence of severe side effects, or no clinical benefit.
The primary endpoint is 6-month PFS rate.
Conclusions
This is the first study to evaluate the safety and efficacy of ICI combined with docetaxel
and ramucirumab. The findings could provide valuable information for developing new
treatment strategies for NSCLC patients.
Keywords
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Article info
Publication history
Published online: June 21, 2022
Accepted:
June 12,
2022
Received:
May 5,
2022
Identification
Copyright
© 2022 Elsevier Inc. All rights reserved.
