A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab Maintenance Following First-Line Platinum Based Chemotherapy in Patients with Metastatic Squamous - Non-Small Cell Lung Cancer (sNSCLC).
Patients with squamous non-small cell lung cancer and an ECOG of 0-1 who received a first-line therapy with Cis-/Carboplatin for at least 2 cycles that had at least Complete Response (CR) / Partial Response (PR) / Stable Disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 will be randomized either to Arm A Pembrolizumab or to Arm B Placebo for a maximum of 2 years or until progressive disease or unacceptable toxicity. The aim is to investigate the efficacy of Pembrolizumab vs. placebo in terms of progression-free survival in patients with metastatic squamous, non-small cell lung cancer. Furthermore to evaluate tumor response, survival, tolerability and safety as well as quality of life of patients receiving Pembrolizumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
41
LungenClinic Grosshansdorf
Großhansdorf, Germany
progression-free survival (PFS)
progression-free survival according to RECIST 1.1
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 35 months.
overall response rate (ORR)
Efficacy measure
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 35 months.
overall survival
Efficacy measure
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 35 months.
PD-L1 expression in tumor samples
assessment of the prognostic value of PD-L1 expression in tumor samples obtained prior to study enrollment
Time frame: samples at baseline taken ; collection up to 35 months
Safety (adverse events graded according to US NCI Common terminology criteria for adverse events)
Safety (intensity and incidence of adverse events, graded according to US NCI Common terminology criteria for adverse events (CTCAE) Version 4.03)
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 35 months.
Functional Assessment of Cancer Therapy for patients with Lung cancer
with the FACT-L questionnaire as part of the quality of life assessment
Time frame: every 6 weeks until EOT for approx. 7 months
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Lung Cancer Symptom Scale (LCSS)
as part of the quality of life assessment
Time frame: every 6 weeks until EOT for approx. 7 months