Re-challenge Pembrolizumab Study as a Second or Further Line in Patients With Advanced NSCLC

Sponsor
Spanish Lung Cancer Group
Study ID
NCT03526887
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    200 mg, Q3W
  • Pembrolizumab — DRUG
    200 mg, Q3W

Study Details

Exploratory phase II trial of intravenous (IV) Pembrolizumab MK-3475 as second or further line with advanced Non-small cell Lung Cancer (NSCLC) who have failed to a prior treatment with anti-PDL1 drug. Pembrolizumab 200 mg ,Q3W, IV infusion, Day 1 of each 3 week cycle will be administered until disease progression.

Key Dates

Start date
Jul 15, 2018
Status verified
Mar 2025
Primary completion
Dec 30, 2022
Completion
Mar 9, 2023

Study Design

Enrollment
73 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Patients who experienced progression disease while on treatment progression disease \< 12 weeks after stopping treatment. After that the patients took chemotherapy ≥ 4 cycles and progressed again. After the last progression the patient is included in the study to be retreated with Pembrolizumab 200mg
  • Experimental: Cohort 2
    Stop treatment and progression \> 12 weeks after stopping treatment. After the last progression the patient is included in the study to be retreated with Pembrolizumab 200mg

Primary Outcome Measure

Efficacy of Pembrolizumab Re-challenge Measured by Overall Survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months. ]

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