Pembrolizumab alone versus pembrolizumab-chemotherapy in first line NSCLC

Phase 3

Recruiting

Conditions: lung cancer
NSCLC
10038666

Registration Number: NL-OMON55042

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 84

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• Histologically confirmed NSCLC, negative for EGFR and ALK mutations
• WHO PS 0-2
• No prior systemic therapy
• High PD-L-1 expression (>=50% TPS)
• High tumor burden (metastases (M1)) and not amenable for local consolidative
therapies

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Patients amenable for local consolidative therapies
• Use of steroids equivalent to >10 mg prednisolon per day prior to start of
study
• Untreated brain metastases
• Adequate bone marrow and organ functions (renal and liver)
• Uncontrolled active infections, HIV
• Autoimmune diseases and interstitial lung diseases are to be excluded
depending on physicians decision

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. ORR, as defined by partial response (PR) and complete response (CR) at week<br /><br>6<br /><br>2. Disease control rate (DCR), as defined by stable disease (SD) and PR and CR<br /><br>at week 6 </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. PFS, as determined using Response Evaluation Criteria in Solid Tumors<br /><br>(RECIST1.1) and defined as time to the development of new lesions, progression<br /><br>of existing lesions, or death, whichever comes first.<br /><br>2. PFS-2, as defined by the PFS on second line chemotherapy in arm 1.<br /><br>3. ORR-2, as defined by the ORR on second line chemotherapy in arm 1.<br /><br>4. Overall Survival (OS). Time frame: Baseline until death.<br /><br>5. Safety defined as the percentage of patients with adverse events. Adverse<br /><br>events will be defined as described in the Common Terminology Criteria for<br /><br>Adverse Events (CTCAE).</p><br>