Pembrolizumab + Platinum Doublets Without Radiation for Programmed Death-ligand 1 (PD-L1) ≥50% Locally Advanced NSCLC

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

December 1, 2019

Primary Completion Date

November 30, 2021

Study Completion Date

November 30, 2023

Conditions
Locally Advanced Non-small Cell Lung Cancer
Interventions
DRUG

Pembrolizumab

Pembrolizumab 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.

DRUG

Cis Platinum

In patients with non-squamous histology, cisplatin (75 mg/m2) will be administered every 3 weeks until 4 cycles with pemetrexed and pembrolizumab.

DRUG

Carboplatin

In cisplatin-intolerable patients, carboplatin (AUC=6) will be administered every 3 weeks until 4 cycles with pemetrexed and pembrolizumab.

DRUG

Pemetrexed

In 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.

DRUG

nab paclitaxel

In patients with squamous histology, nab-paclitaxel (100 mg/m2, day 1, 8, 15, tri-weekly) will be administered until 4 cycles with pembrolizumab.

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Kobe Minimally Invasive Cancer Center

OTHER