Clinical trial NCT03293680
Conditions: Non Small Cell Lung Cancer
Sponsor: Spanish Lung Cancer Group
Start date: 2017-01-15; Completion date: 2023-07-15
Enrollment: 83 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multi-center phase II trial of intravenous (IV) Pembrolizumab MK-3475 in subjects older than 70 years with advanced Non-small cell Lung Cancer (NSCLC) expressing Programmed death-ligand 1 (PD-L1). 82 patients will be enrolled in this trial to examine the efficacy, the impact on geriatric assessments, the quality of life and the self-reported outcomes.

Detailed description:
Subjects will receive MK-3475 at a fixed dose of 200 mg every 3 weeks (Q3W) (Figure 1). Subjects will be evaluated every 9 weeks (63 ± 7 days) with radiographic imaging to assess response to treatment. QoL and Self-reported Health Questionnaires, as well as geriatric follow-up will be performed at the same intervals. Investigators will make all treatment-based decisions using immune-related Response Criteria (irRC). However, for determination of overall response rate (ORR) and progression-free survival (PFS), the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 will be used. Adverse events will be monitored throughout the trial and graded in severity according to the guidelines outlined in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Treatment with MK-3475 will continue until two years of therapy have been administered, documented disease progression, unacceptable adverse event(s), intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the subject, subject withdraws consent, noncompliance with trial treatment or procedure requirements, or administrative reasons.

After the end of treatment, each subject will be followed for a minimum of 30 days for adverse event monitoring (serious adverse events will be collected for up to 90 days after the end of treatment unless the subject starts a new anticancer therapy between days 31 and 90). Subjects will have post-treatment follow-up for disease status, including initiating a non-study cancer treatment and experiencing disease progression, until death, withdrawing consent, or becoming lost to follow-up.

Participation in this trial will be dependent upon supplying tumor tissue from a newly obtained formalin-fixed specimen from locations not radiated prior to biopsy. The specimen will be evaluated at a central laboratory facility for expression status of Programmed death-ligand 1(PD-L1) in a prospective manner. Only subjects whose tumors express Programmed death-ligand 1(PD-L1) as determined by the central laboratory facility will be eligible for inclusion in this study.

Arms: arm 1: 1 group, Pembrolizumab (MK-3475) 200 mg, every 3 weeks
Interventions: intervention 1: Pembrolizumab
Intervention descriptions: intervention 1: Pembrolizumab (MK-3475) 200 mg, every 3 weeks

Protocol documents:
Prot_SAP_000.pdf: 
 
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 Official Title: 
 
 
 
NCT Number: 
 
 
 
Document Dates: Summary of Protocol Amendment Version 2.1:  
28 December 2018 
 


 
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Contacts 
 
Trial Chair (Principal 
Investigator) 
Dr. Remei Blanco, Ph D  
Oncology Service 
Consorci Sanitari de Terrassa 
Ctra. Torrebonica, s.n. 
08227 Terrassa, Barcelona 
Seguridad y Regulación 
(Safety and Regulatory 
Affairs) 
Avenida Meridiana 358, 6ªplanta 
08027 Barcelona 
Tel. 93 430 20 06 
Fax. 93 419 17 68 
Email: 
pharmacovigilance.slcg@gecp.org 
Monitor/CRA 
 
 
 
Project Manager 
Kenia López 
Avenida Meridiana 358, 6ªplanta 
08027 Barcelona 
Tel. 93 430 20 06 
Fax. 93 419 17 68 
Eva Pereira 
Avenida Meridiana 358, 6ªplanta 
08027 Barcelona 
Tel. 93 430 20 06 
Fax. 93 419 17 68 
 


 
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Signature 
 
 
 
Dr. Mariano Provencio 
Fundación GECP President 


 
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INDEX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
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Main inclusion criteria: 
-Treatment-naive stage IV NSCLC 
-Squamous and non-Squamous 
Basal screening 
CGA 
MK-3475 
200 mg Q3W 
PD 
SFU 
CGA = Comprehensive Geriatric Assessment        PD = Progressive Disease   
SFU = Survival Follow-up   


 
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Fundación GECPAvenida Meridiana 358, 6ªplanta 
08027 Barcelona 
 
Monitor 
Kenia López 
Fundación GECPAvenida Meridiana 358, 6ªplanta  
08027 Barcelona 
e-mail: klopez@gecp.org 
 


 
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1
2
J ClinOncol 2008 
26: 4617–25. 
 
3 R. Blanco, I. Maestu, M. G. de la Torre et al. 
4
5
6
7
8
9Garon EB, Rizvi NA, Hui R, et al. 
 


 
 
 
 
 
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11
Lancet 2016; 387: 1540–50 
 
12 Reck M, Delvys Rodríguez-Abreu D,  Robinson AG, et al.  
15 Repetto L, Fratino L, Audisio RA, et al. 
16
17
18
J Natl Cancer Inst 2012;104:1133–1163. 
 
 Gironés R, Torregrosa D, Gomez-Codina J et al. 
22
 


 
 
 
 
 
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