A phase II single-arm trial evaluating safety and efficacy of Durvalumab in ECOG Performance Status 2-3, treatment-naive, patients with stage IV Non-Small Cell Lung Cancer (NSCLC) and high PD-L1 tumor expression

IFCT0 sites67 target enrollmentApril 9, 2019

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patient with a non small cell lung cancer and a poor general status
Sponsor: IFCT
Enrollment: 67
Status: Active, not recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

April 9, 2019

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

IFCT

•1\.Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.
•Subjects must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.
•2\.Histologically or cytologically\-proven NSCLC (squamous or non\-squamous).
•If the diagnosis is cytologically\-proven, sufficient material is necessary with at least 100 tumor cells evaluated for PD\-L1 IHC.
•3\.PD\-L1 expression \=25% of tumor cells as assessed by the local pathology laboratory using protocols validated.
•4\.Available tumor samples for centralized PD\-L1 immunohistochemistry analysis.
•5\.No EGFR mutation and no ALK gene rearrangement.
•6\.Stage IV (8th classification TNM) M1a or M1b or M1c with 3 or lower of metastatic organ sites on PET\-CT. Multiple lesions in a single organ are considered as one metastatic organ site. Any positive distant (non regional) lymph nodes were counted collectively as one metastatic organ site.
•7\.ECOG PS\= 2 (in the first step) or 3 (in the second step) despite optimal symptomatic treatment.
•8\.Body weight \>30kg

•1\.Pure or combined SCLC.
•2\.Known HER2, B\-Raf, activating tumor mutations, or exon 14 c\-MET splice mutations, or known ROS1 gene rearrangement.
•3\.Asymptomatic or symptomatic brain metastasis.
•4\.Carcinomatous meningitis.
•5\.Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
•\-Patients with vitiligo or alopecia
•\-Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
•\-Any chronic skin condition that does not require systemic therapy
•\-Patients without active disease in the last 5 years may be included but only after consultation with IFCT
•\-Patients with celiac disease controlled by diet alone