Study of Pembrolizumab Maintenance Following First-Line Platinum Based Chemotherapy in Patients With Metastatic Squamous - Non-Small Cell Lung Cancer (sNSCLC)

NCT02564380 | Terminated Phase 2 DMC

• 1 other identifier: AIO-TRK-0115
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Metastatic Squamous Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

  progression-free survival according to RECIST 1.1

  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.

Secondary Outcomes (6)

• overall response rate (ORR)

  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

  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

  samples at baseline taken ; collection up to 35 months

• Safety (adverse events graded according to US NCI Common terminology criteria for adverse events)

  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

  every 6 weeks until EOT for approx. 7 months

Study Arms (2)

Arm A: Pembrolizumab

EXPERIMENTAL

Pembrolizumab 200 mg every three weeks until disease progression (maximum 2 years)

Drug: Pembrolizumab

Arm B: Placebo

PLACEBO COMPARATOR

Placebo i.v. every three weeks until disease progression (maximum 2 years)

Drug: Placebo

Interventions

Pembrolizumab DRUG

Also known as: MK-3475

Arm A: Pembrolizumab

Placebo DRUG

Arm B: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient, age ≥ 18 years
• Signed informed consent
• Ability to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
• At least one measurable tumor lesion according to RECIST 1.1
• Histologically or cytologically confirmed diagnosis of stage IV (AJCC Version 7) squamous non-small cell lung carcinoma
• Complete response, partial response or stable disease after at least 2 cycles of first-line chemotherapy with cisplatin or carboplatin
• Last administration of platinum based first-line chemotherapy ≤ 5 +/- 1 week(s) prior first dose of study treatment
• Tumor specimen before first-line chemotherapy available for immunohistochemistry (IHC) of PD-L1 at a central laboratory. Tumor specimen must be a tumor block not a pre-cut slide.
• Adequate bone-marrow and organ function:
• Absolute neutrophil count ≥ 1.5 x 10\^9/L and
• Thrombocytes ≥ 100 x 10\^9/L and
• Hemoglobin ≥ 9 g/dL
• International Normalized Ratio (for blood clotting time) (INR) ≤ 1.5 and Partial Thromboplastin Time (PPT) ≤ 1.5 x upper limit during the last 7 days before therapy
• Bilirubin \< 1.5 x Upper Limit of Normal (ULN) and

You may not qualify if:

• Patients with any of the following will not be eligible for the study:
• Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to treatment start. It is permissable that a patient is in the follow-up phase of any previous study.
• Patient received systemic steroid therapy within three days prior to the first dose of study treatment or received any other form of immunosuppressive medication
• History of allogeneic tissue/solid organ transplant
• History of pneumonitis or interstitial lung disease that has required oral or i.v. steroids
• Radiotherapy of target lesion ≤ 28 days prior first dose of study treatment
• Major surgery ≤ 28 days prior first dose of study treatment
• Minor surgery (e.g. venous catheter) ≤ 24 hours prior first dose of study treatment
• Cardiovascular or cerebrovascular disease of clinical relevance: e.g. acute myocardial infarction or stroke during the last 6 months, unstable angina, relevant and unstable dysrhythmia (controlled Tachyarrhythmia absoluta (TAA) allowed).
• Wound healing disorders, active ulcus ventriculi/duodenal ulcer, bone fracture
• Known active Hepatitis B virus (HBV), Hepatitis C virus (HCV) or HIV infection
• Has any other active infection requiring systemic therapy.
• Patients with active tuberculosis
• Prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-PD-L1, anti-Programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor (TNFR) family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
• Female patient pregnant or breastfeeding, or expecting to conceive or father children during the study and through 120 days after last administration of study drug

Sponsors & Collaborators

• AIO-Studien-gGmbH: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

LungenClinic Grosshansdorf

Großhansdorf, Germany

Location

Related Links

• Description: Working Group for Medical Oncology (AIO) from the German Cancer Society (DKG)

MeSH Terms

Interventions

pembrolizumab

Study Officials

• Martin Reck, PD Dr.

  LungenClinic Grosshansdorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2015
• First Posted: September 30, 2015
• Study Start: January 19, 2016
• Primary Completion: May 23, 2020
• Study Completion: November 23, 2020
• Last Updated: January 4, 2022

Record last verified: 2021-12

Locations

DE (1)