Durvalumab (MEDI4736) in Frail and Elder Patients With Metastatic NSCLC (DURATION)

  • STATUS
    Recruiting
  • End date
    Dec 29, 2022
  • participants needed
    200
  • sponsor
    AIO-Studien-gGmbH
Updated on 29 January 2021
platelet count
paclitaxel
systemic therapy
measurable disease
serum bilirubin level
neutrophil count
carboplatin
gemcitabine
medi4736
durvalumab
cancer chemotherapy
solid tumour
vinorelbine
stage iv non-small cell lung cancer
carboplatin/paclitaxel
kidney function test

Summary

AIO-YMO/TRK-0416 (DURATION) is a open-label, treatment stratified and randomized phase II study of Durvalumab, frail or elderly patients with metastatic non-squamous NSCLC with no targetable molecular alterations (EGFRwt; ALKtransl-) and not amenable to cisplatinum-based standard-combination chemotherapy but eligible for at-least mono-chemotherapy with gemcitabine or vinorelbine.

Description

The primary objective is to assess the safety and tolerability of sequential therapy consisting of standard of care mono- or combination chemotherapy followed by durvalumab in comparison to standard of care mono- or combination chemotherapy in frail/elderly patients.

Details
Condition Non-Small Cell Lung Cancer, Lung Metastasis, Metastatic Lung Cancer, Lung Metastases, Lung Adenocarcinoma Metastatic, Large Cell Lung Carcinoma Metastatic, Pulmonary Metastasis, nsclc
Treatment carboplatin, Gemcitabine, Nab-paclitaxel, Vinorelbine, durvalumab
Clinical Study IdentifierNCT03345810
SponsorAIO-Studien-gGmbH
Last Modified on29 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
Age 70 years at time of study entry and/or Charlson-Comorbidity-Index (CCI) >1 and/or Performance status ECOG >1
Histologically confirmed diagnosis of metastatic NSCLC and no targetable molecular alterations (EGFRwt; ALKtransl-) and not amenable to cisplatinum-based standard-combination chemotherapy
Patients with measurable disease (at least one uni-dimensionally measurable target lesion not previously irradiated, by CT-scan or MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) are eligible
A formalin fixed, paraffin-embedded (FFPE) tumor tissue block (fresh or archival less than 3 years old or recent) or a minimum of 10 unstained slides of tumor sample (slices must be less than 90 days old and collected on SuperFrost slides provided by the sponsor) must be available for biomarker (PD-L1) evaluation. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is inappropriate
No prior chemotherapy or any other systemic therapy for metastatic NSCLC. Patients who have received prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for locally advanced disease are eligible, provided that progression has occurred >6 months from last therapy
Prior radiotherapy and surgery are allowed if completed 4 weeks (for minor surgery and palliative radiotherapy for bone pain: 2 weeks) prior to start of treatment and patient recovered from toxic effects or associated adverse events
Adequate blood count, liver-enzymes, and renal function
Haemoglobin 9.0 g/dL
Absolute neutrophil count (ANC) 1.5 x 109/L (> 1500 per mm3)
Platelet count 100 x 109/L (>100,000 per mm3)
Serum bilirubin 1.5 x ULN. This will not apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
AST (SGOT)/ALT (SGPT) 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be 5x ULN
Serum creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits, examinations including follow up and appropriate contraception

Exclusion Criteria

Mixed small-cell lung cancer and NSCLC histology
Mean QT interval corrected for heart rate (QTc) 470 ms calculated from 3 electrocardiograms (ECGs) using Fredericia's correction
History of another primary malignancy except local prostate cancer without need for systemic treatment (e.g. active surveillance, operation without need for adjuvant treatment) and malignancies treated with curative intent and with no known active disease >2 years befor the first dose of study drug and of low potential risk for recurrence, e.g. adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, adequately treated carcinoma in situ without evidence of disease (e.g. cervical cancer in situ)
Pre-existing peripheral neuropathy of Grade 2
Brain metastasis or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatement
Active or prior documented autoimmune disease within the past 2 years. NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
History of primary immunodeficiency
History of allogeneic organ transplant
History of hypersensitivity to durvalumab or any excipient
History of hypersensitivity to any of the comparator agents
Medication that is known to interfere with any of the agents applied in the trial
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
Clinical diagnosis of active tuberculosis
Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab
Male patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year)
Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
Participation in another clinical study with an investigational product during the last 30 days before inclusion
Any previous treatment with a PD-1 or PD-L1 inhibitor, including durvalumab
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 21 days prior to the first dose of study drug or 4 half-lifes of the agent administered, which ever comes first
Previous enrollment or randomization in the present study
Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff of sponsor and study site)
Patient who might be dependent on the sponsor, site or the investigator
Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities 40 Abs. 1 S. 3 Nr. 4 AMG
Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [ 40 Abs. 1 S. 3 Nr. 3a AMG]
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