This is a phase II, multicenter, single-arm, non-blind study. To 21 patients with PD-L1 ≥50% locally advanced non-small cell lung cancer, the combination of Pembrolizumab and platinum-doublets will be intravenously administered without radiotherapy to evaluate the efficacy and safety of combination therapy with Pembrolizumab and platinum-doublets.
Histologically confirmed NSCLC
PD-L1 Total Proportion Score (TPS) ≥50%
Locally advanced NSCLC (unresectable stage III with indication of curative CRT based on Tumour, Node and Metastasis (TNM) classification of Union for International Cancer Control (UICC) version 8)
Treatment naïve for primary disease
A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., Cytotoxic T Lymphocyte-associated Antigen 4 (CTLA-4), OX-40, CD137).
Has received any prior systemic anti-cancer therapy. Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
Single group
Pembrolizumab
DrugPembrolizumab at 200 mg (day 1) will be administered to patients with non-squamous cell carcinoma at 3-week intervals. To those with squamous cell carcinoma, Pembrolizumab at 200 mg (day 1) will be administered at 3-week intervals until disease progression or intolerable toxicity. Pembrolizumab administration should be continued for 2 years involving induction and maintenance therapies or until the 35th course.
Cis Platinum
DrugIn patients with non-squamous histology, cisplatin (75 mg/m2) will be administered every 3 weeks until 4 cycles with pemetrexed and pembrolizumab.
Carboplatin
DrugIn cisplatin-intolerable patients, carboplatin (AUC=6) will be administered every 3 weeks until 4 cycles with pemetrexed and pembrolizumab.
Pemetrexed
DrugIn patients with non-squamous histology, pemetrexed (500 mg/m2) will be administered every 3 weeks until progression or 2 years after initiation (35 cycles) with pembrolizumab.
nab paclitaxel
DrugIn patients with squamous histology, nab-paclitaxel (100 mg/m2, day 1, 8, 15, tri-weekly) will be administered until 4 cycles with pembrolizumab.
2-year PFS rate
Number of non-progression cases/all enrolled cases at 2 years
Response rate
According to RECIST
PFS
According to Kaplan meier curve
OS
According to Kaplan meier curve
Adverse events
Analysis of grade and incidence of adverse events
EFFICACY assessed by Response rate in percent according to PD-L1 Total Proportion Score in percent
Differences of Response rate in percent according to PD-L1 Total Proportion Score in percent
EFFICACY assessed Progression-free survival in months according to PD-L1 Total Proportion Score in percent
Differences of Progression-free survival in months according to PD-L1 Total Proportion Score in percent
EFFICACY assessed by Overall survival in months according to PD-L1 Total Proportion Score in percent
Differences of Overall survival in months according to PD-L1 Total Proportion Score in percent
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Kobe Minimally Invasive Cancer Center
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
