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Phase II Trial of Continuation Therapy in Advanced NSCLC

NCT03083808 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-08-24

Study results available
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Summary

This is a single-arm phase II study of continuation immunotherapy with pembrolizumab following initial benefit (CR, PR, or SD ≥ 3 months) with a PD-1 or PD-L1 inhibitor.

Conditions

  • Non-Small-Cell Lung Cancer

Interventions

DRUG

Pembrolizumab

Pembrolizumab 200mg IV every 21 days \+ Physician's choice chemotherapy with one of the following every 21 days: * Docetaxel 75mg/m2 IV * Pemetrexed 500mg/m2 IV (non-squamous only) * Gemcitabine 1000mg/m2 IV on days 1 and 8

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Big Ten Cancer Research Consortium

    collaborator OTHER

  • Greg Durm, MD

    lead OTHER

Principal Investigators

  • Greg Durm, M.D. · Big Ten Cancer Research Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-20
Primary Completion
2021-12-14
Completion
2022-03-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT03083808 on ClinicalTrials.gov