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

NCT04153734 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2019-11-06

No results posted yet for this study

Summary

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Akito Hata · Kobe Minimally Invasive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2021-11-30
Completion
2023-11-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04153734 on ClinicalTrials.gov