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NSCLC, Stage IIIPhase 2ESPADURVANCT04202809

Phase-II Trial of Induction Chemotherapy and Chemoradiotherapy Plus/Minus Durvalumab and Consolidation Immunotherapy in Patients With Resectable Stage III NSCLC.

A Phase 2 study testing Durvalumab in people with NSCLC, Stage III, run by University Hospital, Essen at 7 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To compare a complex induction multimodality protocol (ESPATUE) + concurrent immunotherapy with PD-L1 antibody Durvalumab given every three weeks to the same induction multimodality protocol without Durvalumab immunotherapy induction followed by definitive local treatment (surgery for those considered resectable or… Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
NSCLC, Stage III
What is being tested?
Durvalumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
7 sitesGermany
Study dates
13 Jan 2020to Apr 2025
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 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Body weight >30 kg
  • Age ≥ 18 years and < 75 years
  • Male or female patients. Female (as well as male) patients have to take care of effective measures of anticonception
  • Histologically proven non-small cell lung cancer
  • Selected patients with non-small cell lung cancer stages IIIA and IIIB:
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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  • Resectable disease at the time of inclusion
  • Fulfillment of adequate criteria for functional and medical resectability as described in the European Respiratory Society (ERS)/European Society of Thoracic Surgeons (ESTS) guidelines [Brunelli et al 2009] and acceptable general clinical condition for multimodality treatment (interdisciplinary committee)
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (e.g, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
  • Must have a life expectancy of > 12 weeks
  • Adequate normal organ and marrow function
  • Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  • Stable cardiac function (no Myocardial infarction (MI) within 6 months, no heart failure according to New York Heart Association (NYHA) III-IV).

Who cannot join

  • resectable IIB or selected IIIA (T3N0; T3N1)
  • unresectable disease pre-treatment
  • mixed histology with areas of small cell carcinoma (neuroendocrine markers)
  • clinically symptomatic vena cava superior syndrome
  • diffuse mediastinal involvement
  • patients with T3N3 and T4N3 tumors (IIIC according to International Association for the Study of Lung Cancer (IASLC)/Union Internationale Contre le Cancer (UICC) 8)
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  • invasion of the thoracic aorta (T4 - aorta)
  • invasion of the heart (except left atrium - T4 - heart)
  • invasion of the esophagus (T4 - esophagus)
  • invasion of spine (T4 - spine)
  • (full blown) Pancoast-syndrome in tumors of the superior sulcus (T3-4 Nx)
  • malignant (positive) pericardial effusion (M1a - pericardial effusion)
  • malignant (positive) pleural effusion (M1a - pleural effusion)
  • involvement of the contralateral hilar nodes (if any data available)
  • endobronchial tumor extension to the contralateral main stem bronchus
  • ipsi- or contralateral supraclavicular nodes (N3 - supraclavicular nodes)
  • lung or heart function not allowing at the time of inclusion the intended surgical procedure
  • previous administration of chemotherapy and/or radiotherapy
  • previous immunotherapy
  • insufficient patients compliance (e.g. symptomatic psychiatric disorder)
  • loss of weight > 10 % in the last six months
  • missing written informed consent or definitive refusal for participation
  • Participation in another clinical study with an investigational product during the last 12 months
  • Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
  • Must not have required the use of additional immunosuppression other than corticosteroids for the management of an Adverse Event (AE), not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day
  • History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest CT scan
  • Any concurrent chemotherapy, Intraperitoneal (IP), biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
  • Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
  • History of allogenic organ transplantation.
  • History of a stem cell transplantation
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]).
  • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
  • History of another primary malignancy
  • History of active primary immunodeficiency
  • Active infection including tuberculosis (TB) (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive Hepatitis B Virus (HBV) surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV ½ antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody (anti-HBc) and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of Durvalumab.
  • Current or prior use of immunostimulatory agents within 14 days before the first dose of Durvalumab.
  • Receipt of live attenuated vaccine within 90 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 90 days after the last dose of IP.
  • Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of Durvalumab monotherapy.
  • Known allergy or hypersensitivity to Durvalumab or any excipient

Trial locations and contacts

7 sites in 1 country.

Andrea Moell, PhD contact

0049 201 72377412 ext. 77412

andrea.moell@uk-essen.de

7 sites in 1 country

Germany7 sites, 7 recruiting

  • Universitätsklinikum Essen

    Essen, 45147

    Recruiting

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

    Recruiting

  • Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH

    Hemer, 58675

    Monika Serke, MD

    Recruiting

  • Klinikum rechts der Isar - Technische Universität München

    Munich, Bavaria, 81675

    Stephanie Combs, Prof. Dr.

    Recruiting

  • Pius-Hospital Oldenburg

    Oldenburg, 26121

    Recruiting

  • Universitätsklinikum Regensburg

    Regensburg, 93042

    Christian Schulz, Prof. Dr.

    Recruiting

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376

    Recruiting

Other trials in Germany

About this study

Official title: Prospective Phase-II Trial of Induction Chemotherapy and Chemoradiotherapy Plus/Minus the PD-L1 Antibody Durvalumab Followed by Surgery or Definitive Chemoradiation Boost and Consolidation Durvalumab in Resectable Stage III NSCLC.

To compare a complex induction multimodality protocol (ESPATUE) + concurrent immunotherapy with PD-L1 antibody Durvalumab given every three weeks to the same induction multimodality protocol without Durvalumab immunotherapy induction followed by definitive local treatment (surgery for those considered resectable or chemoradiation boost for those not considered to be R0-resectable) followed by consolidation Durvalumab treatment in both arms.

Being tested
Durvalumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • DurvalumabDrug

    Durvalumab is given earlier as registered, during chemotherapy and radiotherapy in treatment Arm A

Study groups in NCT04202809
Study groupRoleWhat they receive
Chemo- and Radiochemotherapy + DurvalumabExperimentalNot described
Receives: Drug: Durvalumab
Chemo- and RadiochemotherapyNo interventionNot described

What is being measured

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

  1. Progression-free survival (PFS)

    Two-year progression-free survival rate

    Measured: 2 years

Secondary outcomes (8)

  1. Overall survival

    Measured: after 1, 2, 3, 4 and 5 years

  2. 2-y-overall survival rate

    Measured: 2 years

  3. Functional response

    to investigate functional response (PET-CT-scan) to induction therapy prior to thoracotomy

    Measured: Week 15

  4. RECIST response (induction)

    to investigate RECIST response to induction therapy in the whole Population and in both arms.

    Measured: Week 9

  5. RECIST criteria

    Radiological response

    Measured: Through study completion, an average of every 2 months for up to 11 months

  6. EORTC QLQ-C30

    Quality of life (QLQ-C30)

    Measured: Through study completion, an average of every 6 weeks for up to 11 months

  7. EORTC QLQ-LC13

    Quality of life (QLQ-Lung Cancer 13(LC13))

    Measured: Through study completion, an average of every 6 weeks for up to 11 months

  8. FACT-L

    Quality of life (Functional Assessment of Cancer Therapy-Lung (FACT-L))

    Measured: Through study completion, an average of every 6 weeks for up to 11 months

Timeline

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

  1. First posted18 Dec 2019
  2. Study start13 Jan 2020
  3. Primary completionApr 2025 (estimated)
  4. Study completionApr 2025 (estimated)

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
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04202809
Sponsor's protocol ID
ESPADURVA
Acronym
ESPADURVA
Status last verified
May 2023
First submitted
4 Dec 2019
Last updated
10 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab in people with NSCLC, Stage III, run by University Hospital, Essen at 7 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 14 inclusion and 40 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: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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?

Results are not available in the source record.

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

Contact Andrea Moell, PhD (0049 201 72377412 ext. 77412, andrea.moell@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: 2 years). 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 NCT04202809.

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 10 May 2023.

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