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Carcinoma, Non-Small-Cell LungPhase 2DURATIONNCT03345810

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

A Phase 2 study testing Durvalumab, Vinorelbine and Gemcitabine in people with Carcinoma, Non-Small-Cell Lung and Metastatic Lung Cancer, run by AIO-Studien-gGmbH at 30 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 70 years and older
What is being tested?
Durvalumab, Vinorelbine and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
30 sitesGermany
Study dates
14 Dec 2017to 31 Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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].

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

Germany30 sites

  • Gesundheitszentrum St. Marien GmbH

    Amberg, 92224

  • Ev. Lungenklinik Berlin

    Berlin, 13125

  • Kliniken der Stadt Köln gGmbH

    Cologne, 51109

  • Klinikum Darmstadt

    Darmstadt, 64283

  • Universitätsklinikum Carl-Gustav-Carus

    Dresden, 01307

  • Klinikum Esslingen

    Esslingen am Neckar, 73730

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60590

  • Klinik Schillerhöhe

    Gerlingen, 70839

  • Universitätsmedizin Greifswald

    Greifswald, 17475

  • Onkodoc GmbH

    Gütersloh, 33332

  • Krankenhaus Martha-Maria Halle Dölau

    Halle, 06120

  • Department of Thoracic Oncology, Thoraxklinik at Heidelberg University Hospital

    Heidelberg

  • Lungenklinik Hemer

    Hemer, 58675

  • "Vincentius-Diakonissen-Kliniken gAG

    Karlsruhe, 76137

  • Ortenau-Klinikum Lahr

    Lahr, 77933

  • Ev. Diakonissenkrankenhaus Leipzig

    Leipzig, 04177

  • Klinik Löwenstein gGmbH

    Löwenstein, 74245

  • Klinikum Ludwigsburg

    Ludwigsburg, 71640

  • DRK-Kliniken Berlin Mitte

    Mitte, 13359

  • Klinikum der Universität München

    München, 81377

  • Pius Hospital Oldenburg

    Oldenburg, 26121

  • Krankenhaus Barmherzige Brüder

    Regensburg, 93049

  • "Klinikum Rheine

    Rheine, 48341

  • Marienhospital

    Stuttgart, 70199

  • Krankenhaus der Barmherzigen Brüder

    Trier, 54292

  • Universitätsklinikum Ulm

    Ulm, 89081

  • Schwarzwald-Baar Klinikum

    Villingen-Schwenningen, 78052

  • SHG-Kliniken-Völklingen

    Völklingen, 66333

  • Hämatologisch-Onkologische Praxis Würselen

    Würselen, 52146

  • Klinikum Würzburg Mitte gGmbH

    Würzburg, 97074

Other trials in Germany

About this study

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.

Read the detailed 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.

Keywords
NSCLC, Non small cell lung cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DurvalumabDrug

    Also called MEDI4736

    Induction: (1125 mg) cycle Q3W Maintenance: (1500 mg) cycle Q4W

  • VinorelbineDrug

    (30 mg/m2 D1 + D8 as infusion) cycle Q3W

  • GemcitabineDrug

    (1000 mg/m2 D1 + D8 as infusion) cycle Q3W

  • nab-PaclitaxelDrug

    Also called Abraxane

    (100 mg/m2 intravenous infusion over 30 minutes on D1, D8) cycle Q3W

  • CarboplatinDrug

    (AUC = 5 mg•min/mL on Day 1) cycle Q3W

Study groups in NCT03345810
Study groupRoleWhat they receive
Control Arm AActive comparatorFrail or elderly patients with metastatic NSCLC; CARG- Score ≤ 3 Carboplatin (AUC 5.0; D1) + nab-Paclitaxel (100mg/m2 D1,D8) Q3W
Receives: Drug: nab-Paclitaxel; Drug: Carboplatin
Experimental Arm BExperimentalFrail or elderly patients with metastatic NSCLC; CARG- Score ≤ 3 Induction:Carboplatin (AUC 5.0; D1) + nab-Paclitaxel (100mg/m2) D1,D8; Q3W [2 cyc] followed by durvalumab (1125 mg; Q3W) [ 2 cyc] Maintenance:durvalumab (1500 mg) Q4W
Receives: Drug: Durvalumab; Drug: nab-Paclitaxel; Drug: Carboplatin
Experimental Arm CExperimentalFrail or elderly patients with metastatic NSCLC; CARG- Score > 3 Induction: Vinorelbine (30 mg/m2; D1+D8) Q3W [ 2 cyc] or Gemcitabine (1000 mg/m2; D1+D8) Q3W [ 2 cyc] followed by durvalumab (1125 mg) Q3W [2 cyc] Maintenance:durvalumab (1500 mg; Q4W)
Receives: Drug: Durvalumab; Drug: Vinorelbine; Drug: Gemcitabine
Control Arm DActive comparatorFrail or elderly patients with metastatic NSCLC; CARG- Score > 3 Vinorelbine (30 mg/m2; D1+D8) Q3W or Gemcitabine (1000 mg/m2; D1+D8) Q3W
Receives: Drug: Vinorelbine; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of treatment related Grade III/IV adverse events (CTCAE V4.03)

    Comparison of the outcome of sequential therapy consisting of standard of care mono- or combination chemotherapy followed by durvalumab versus standard of care mono- or combination chemotherapy in frail/elderly patients

    Measured: through study completion, an average of 24 months

Secondary outcomes (8)

  1. PFS

    Progression Free Survival

    Measured: approx. 24 months

  2. ORR using assessment according to RECIST 1.1

    Response Evaluation Criteria In Solid Tumors (RECIST)

    Measured: approx. 24 months

  3. OS

    Overall Survival

    Measured: approx. 60 months

  4. Adverse Events /Serious Adverse Events

    Adverse Events: Type, incidence, and severity according to NCI CTCAE version 4.03

    Measured: approx. 48 months

  5. Health related Quality of Life (HR-QoL)

    as determined with FACT-L (Functional Assessment of Cancer Therapy - Lung)

    Measured: approx. 60 months

  6. Geriatric assessment

    G8-questionnaire

    Measured: approx. 60 months

  7. Geriatric assessment

    Timed up \& go (test of basic functional mobility)

    Measured: approx. 60 months

  8. Geriatric assessment

    6MWT (6 minutes walk test)

    Measured: approx. 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2017
  2. Study start14 Dec 2017
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03345810
Sponsor's protocol ID
AIO-YMO/TRK-0416
Other IDs
2016-003963-20, ESR-15-11003, AX-CL-NSCLC-AIO-008260, 2016
Acronym
DURATION
Status last verified
Jun 2023
First submitted
14 Nov 2017
Last updated
15 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kuon J, Hommertgen A, Krisam J, Lasitschka F, Stenzinger A, Blasi M, Bozorgmehr F, Maenz M, Kieser M, Schneider M, Thomas M. Durvalumab in frail and elderly patients with stage four non-small cell lung cancer: Study protocol of the randomized phase II DURATION trial. Trials. 2020 Apr 22;21(1):352. doi: 10.1186/s13063-020-04280-8.

    PubMed 32321565

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab, Vinorelbine and Gemcitabine in people with Carcinoma, Non-Small-Cell Lung and Metastatic Lung Cancer, run by AIO-Studien-gGmbH at 30 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of treatment related Grade III/IV adverse events (CTCAE V4.03) (time frame: through study completion, an average of 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03345810, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.

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