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AzTrials

Lung Cancer Non-Small Cell Cancer (NSCLC)Phase 2InDuRanSNCT06810609

Immunochemotherapy, Surgery or Chemoradiation, and Durvalumab for Stage IIIA/B NSCLC

A Phase 2 study testing surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines, Chemoradiotherapy and Immunotherapy in people with Lung Cancer Non-Small Cell Cancer (NSCLC), run by University Hospital, Bonn at 5 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The hypothesis of the study is that induction immunochemotherapy, followed by surgery or chemoradiation and consolidation Durvalumab immunotherapy, can significantly improve event-free survival in patients with resectable or borderline resectable NSCLC at stage IIIA/B compared to existing treatment methods. Read more about this study

Who is it for?
Ages 18 to 74 years
What is being tested?
surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines, Chemoradiotherapy and Immunotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
5 sitesGermany
Study dates
20 Apr 2025to 30 Sep 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • 1. Patient is 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 (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.
  • 2. Patient is willing and able to comply with the protocol for the duration of the study 3. Age ≥ 18 years and < 75 years. 4. All sex and gender. 5. Female patients of childbearing potential as well as male patients with partners of childbearing potential must agree to always use a highly effective form of contraception according to the Clinical Trials Facilitation and Coordination Group (CTFG) during the course of this study and for at least 90 days after the last dose of durvalumab or 6 months after the last dose of chemotherapy, whichever occurs last.
  • 6. Evidence of post-menopausal status or negative serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause.
  • 7. Histologically and / or cytologically proven NSCLC (EGFRm-, ALK-). 8.
  • Selected patients with NSCLC stage IIIA/B:
  • IIIA: one or more lymph node levels involved at EBUS/mediastinoscopy T1/T2 N2.
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  • IIIB: one or more lymph node levels involved at EBUS/mediastinoscopy T3/T4 N2. 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 10. Given technical/oncologic complete resectability (R0) at the time of inclusion. 11. Sufficient functional reserves for the planned surgery 12. Fulfilment 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).
  • 13. Life expectancy of > 12 weeks. 14. Body weight > 30 kg. 15.
  • Adequate normal organ and bone marrow function as defined below:
  • Hemoglobin ≥ 9.0 g/dL. b. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L. c. Platelet count ≥ 100 × 109/L. d. Serum bilirubin ≤ 1.5 × institutional upper limit of normal (ULN). (This will not apply to patients 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.
  • Alanine aminotransferase (ALT/SGPT) and aspartate aminotransferase (AST/SGOT) ≤ 2.5 × institutional ULN.
  • Measured creatinine clearance (CL) ≥ 60 mL/min or calculated creatinine CL ≥ 60 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance.
  • 16. Stable cardiac function (no myocardial infarction (MI) within 6 months, no heart failure NYHA III-IV).
  • 17. Discussion in a multidisciplinary tumor board which supports participation in this clinical trial, indicating that both chemoradiotherapy and surgery are possible local treatments.
  • Patients should only be randomized if all of the following inclusion criteria are fulfilled at the time of randomization:
  • Given technical/oncologic complete resectability (R0) at the time of randomization.
  • Sufficient functional reserves for the planned surgery
  • Adequate normal organ and bone marrow function as defined before

Who cannot join

  • 1. Unresectable disease. 2. Mixed histology with areas of small cell carcinoma (neuroendocrine markers). 3. ALK+/ EGFRm disease. 4. Clinically symptomatic vena cava superior syndrome. 5. Diffuse mediastinal involvement. 6. Patients with N3 tumors (IASLC/UICC 8). 7. Invasion of the thoracic aorta (T4 - aorta) or the heart (except left atrium - T4 - heart) or the esophagus (T4 - esophagus), or invasion of spine (T4 - spine) NOTE: T4 with invasion of diaphragm are eligible. 8. Pancoast-syndrome in tumors of the superior sulcus (T3-4 Nx). 9. Metastatic disease (M1). 10. Endobronchial tumor extension to the contralateral main stem bronchus. 11. Lung or heart function not allowing the intended surgical procedure at the time of inclusion.
  • 12. Prior treatments including prior mediastinal irradiation. 13. Insufficient patients' compliance (e.g., symptomatic psychiatric disorder) or missing written informed consent or definitive refusal for participation.
  • 14. Prior randomization of treatment in a previous durvalumab clinical study regardless of treatment arm assignment.
  • 15.
  • Patients who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4:
  • Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
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  • All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.
  • Must not have experienced a ≥ Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy.
  • NOTE: Patients with endocrine AE of ≤ Grade 2 are permitted to be enrolled if they are stably maintained on appropriate replacement therapy and are asymptomatic.
  • Must not have required the use of additional immunosuppression other than corticosteroids for the management of an 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.
  • 16. Participation in another clinical study with an investigational product during the last 12 months.
  • 17. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
  • 18. 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.
  • 19. Any concurrent chemotherapy (other than study therapy), Investigational Product, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
  • 20. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of durvalumab.
  • 21. History of allogenic organ transplantation or a stem cell transplantation. 22.
  • 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]). The following are exceptions to this criterion:
  • Vitiligo or alopecia b. Hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement c. Any chronic skin condition that does not require systemic therapy d. Celiac disease controlled by diet alone e. Patients without active disease in the last 5 years may be included but only after consultation with the study physician 23. 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.
  • 24. History of another primary malignancy except for
  • Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of durvalumab and of low potential risk for recurrence b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease c. Adequately treated carcinoma in situ without evidence of disease 25. History of active primary immunodeficiency. 26. History of leptomeningeal carcinomatosis. 27. Known active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B, hepatitis C, or human immunodeficiency virus (positive HIV-1 or HIV-2). 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.
  • 28.
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
  • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
  • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) 29. Current or prior use of immunostimulatory agents within 14 days before the first dose of durvalumab 30. Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab. Note: Patients, if enrolled, should not receive live vaccine whilst receiving study treatment and up to 90 days after the last dose of study treatment.
  • 31. 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 or 6 months after the last dose of chemotherapy, whichever occurs last.
  • 32. Known allergy or hypersensitivity to any of the study drugs or any of the study drugs excipient.
  • 33. Any medical contraindication to treatment with platin-based doublet chemotherapy as listed in the applying SmPCs.
  • 34. Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.
  • Patients should not be randomized if any of the following exclusion criteria are fulfilled at the time of randomization:
  • 1. Complete remission after induction immunochemotherapy. 2.
  • Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous immunochemotherapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria:
  • Patients with Grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
  • Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician (exception: alopecia).
  • 3. Allergy or hypersensitivity to durvalumab or concurrent chemotherapy drugs or any excipient appearing for the first time during previous immunochemotherapy.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Eleni Gkika, Prof. Dr. med. contact

0049 22825710353

eleni.gkika@ukbonn.de

5 sites in 1 country

Germany5 sites, 5 recruiting

  • University Hospital Bonn

    Bonn, 53127

    Eleni Gkika, Prof. Dr. med., 0049 22828710353, eleni.gkika@ukbonn.de

    Recruiting

  • University Hospital Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

    Cornelius Waller, Prof. Dr. med., 0049 761 270 34220, cornelius.waller@uniklinik-freiburg.de

    Recruiting

  • University Hospital Gießen

    Giessen, Hesse, 35392

    Thomas Wehler, Prof. Dr. med., 0049 641 98543501, oon.studienzentrum@uk-gm.de

    Not yet recruiting

  • Johannes Wesling Klinikum Minden Mühlenkreiskliniken, Hämatologie und Onkologie

    Minden, North Rhine-Westphalia, 32429

    Parvis Sadjadian, Dr. med., 0049 05 71 / 7 90 42 01, haematologie-onkologie@muehlenkreiskliniken.de

    Recruiting

  • Klinikum Stuttgart

    Stuttgart, Baden-Wurttemberg, 70174

    Marc Münter, Prof. Dr. med., 0049 711 278 34201, sekretariat.muenter@klinikum-stuttgart.de

    Recruiting

Other trials in Germany

About this study

Official title: Prospective Randomized Phase II Trial on Induction Immunochemotherapy Followed by Surgery or Definitive Chemoradiation and Consolidation Durvalumab (MEDI4736) in Resectable and Borderline Resectable Stage IIIA/B NSCLC

The hypothesis of the study is that induction immunochemotherapy, followed by surgery or chemoradiation and consolidation Durvalumab immunotherapy, can significantly improve event-free survival in patients with resectable or borderline resectable NSCLC at stage IIIA/B compared to existing treatment methods.

Being tested
surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines, Chemoradiotherapy, Immunotherapy
Keywords
InDuRanS, Non-Small Cell Lung Cancer, Chemoradiation, Resectable NSCLC, Durvalumab, Induction Immunochemotherapy
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.

  • surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesProcedure or surgery

    Surgical removal of the tumor in patients with resectable or borderline resectable NSCLC

  • ChemoradiotherapyRadiation

    Chemoradiotherapy

  • ImmunotherapyDrug

    Immunotherapy (Durvalumab).

Study groups in NCT06810609
Study groupRoleWhat they receive
Surgery + ImmunotherapyExperimentalSurgical removal of metastasis and consolidation Durvalumab immunotherapy.
Receives: Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines; Drug: Immunotherapy
Chemoradiotherapy + ImmunotherapyExperimentalChemoradiotherapy (CRT) followed by consolidation immunotherapy with Durvalumab .
Receives: Radiation: Chemoradiotherapy; Drug: Immunotherapy

What is being measured

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

  1. 2-Year Event-Free Survival (EFS) Rate in Patients with Resectable or Borderline Resectable NSCLC

    2 year EFS rate is defined as percentage of patients without an event specified as relapse or progression according to RECIST 1.1 criteria, secondary tumor, or death of any cause, whichever occurs first, within 2 years after date of randomization.

    Measured: Within 2 years after date of randomization

Secondary outcomes (13)

  1. Analyze the health-related Quality of Life (QoL)

    Changes in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 symptom scales from date of randomization through study completion (an average of 14 months after randomization) and changes in EORTC QLQ-C30 functional scales and global health status from date of randomization through study completion (an average of 14 months after randomization). Higher scores indicate a better outcome.

    Measured: from date of randomization through study completion (an average of 14 months after randomization)

  2. Analyze the health-related Quality of Life (QoL)

    Changes in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) LC13 symptom scales from date of randomization through study completion (an average of 14 months after randomization). Higher scores indicate a better outcome.

    Measured: from date of randomization through study completion (an average of 14 months after randomization)

  3. Occurence of adverse events

    Occurrence of adverse events according to CTCAE (V5.0):

    • adverse events grade ≥ 3 (according to NCI CTCAE v5.0)
    • SAEs
    • Unexpected AEs

    Measured: for 12 months according to arm

  4. Efficacy of multimodality treatment

    Efficacy will be assessed in terms of Overall survival (OS) defined as time from randomization until death due to any cause

    Measured: From Randomization to death from any cause, within 2 years after date of randomization or throughout extended follow-up

  5. Efficacy of multimodality treatment

    Efficacy will be assessed in terms of Progression free survival (PFS) defined as time from randomization to objective disease progression

    Measured: From Randomization to objective disease progression, within 2 years after date of randomization or throughout extended follow-up

  6. Outcome of surgery in resected patients

    Assessment of rate of pathological complete response (pCR), major pathological response (mPR) and R0 in resected patients

    Measured: end of surgery

  7. Response after induction therapy

    Assessment of Functional response (FDG-PET-CT-scan) to induction therapy prior to thoracotomy / chemoradiation according to RECIST and PERCIST in the whole population and in both arms according to CR, PR, SD and PD

    Measured: pre-induction therapy scan in comparison with post-induction therapy scan

  8. Response after induction therapy

    Analysis of the SUVmax response and MTV response on the planning FDG-PET-CT in comparison to the pretreatment FDG-PET-CT

    Measured: pre-induction therapy scan in comparison with post-induction therapy scan

  9. Quantity of PD-L1 positive tumor cells per patient

    Assessment of number of PD-L1 positive tumor cells at screening visit.

    Measured: At screening visit

  10. Rate of patients with < 1%, 1-49% and ≥ 50 % PD-L1 positive tumor cells in the group of stage IIIA/B (N2) NSCLC patients (screened population),

    Assessment of the rate of patients with < 1%, 1-49% and ≥ 50 % PD-L1 positive tumor cells in the group of stage IIIA/B (N2) NSCLC patients (screened population).

    Measured: From Screening

  11. Compliance and treatment toxicity effects

    Assessment of Rate of randomized patients who completed the planned treatment

    Measured: From randomization until end of treatment visit, an average of 14 months after randomization

  12. Compliance and treatment toxicity effects

    Assessment of Rate of patients who discontinued study treatment due to adverse event

    Measured: From randomization until end of treatment visit, an average of 14 months after randomization

  13. Toxicity of ICT and any causes that prevent randomization or surgery or completion of surgery

    Assessment of rate of patients with events / PD that prevent fulfillment of criteria for randomization / surgery

    Measured: Before Randomization

Timeline

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

  1. First posted5 Feb 2025
  2. Study start20 Apr 2025
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion30 Sep 2030 (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
Model description
The study involves randomizing participants to different treatment arms (induction immunochemotherapy, followed by surgery or chemoradiation, and then consolidation Durvalumab immunotherapy), with the goal of comparing the outcomes between those receiving the full treatment regimen and other treatment options.
Masking
None (open label)
Enrolment
176 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06810609
Sponsor's protocol ID
ESR-21-21565
Other IDs
2024-516367-80-00
Acronym
InDuRanS
Status last verified
May 2025
First submitted
24 Jan 2025
Last updated
27 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gkika E, Waller CF, Dejonckheere CS, Layer JP, Meiners J, Brossart P, Rodermann E, Schiefer AS, Munter M, Nicolay NH, Grosu AL, Rimner A, Schmidt J, Schmid S. InDuRanS: neoadjuvant immunochemotherapy followed by surgery or definitive chemoradiotherapy and consolidation durvalumab in resectable and borderline resectable stage IIB-IIIA/B non-small-cell lung cancer. Front Oncol. 2026 Oct 7;16:1909979. doi: 10.3389/fonc.2026.1909979. eCollection 2026.

    PubMed 42908627

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines, Chemoradiotherapy and Immunotherapy in people with Lung Cancer Non-Small Cell Cancer (NSCLC), run by University Hospital, Bonn at 5 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 18 inclusion and 35 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: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Eleni Gkika, Prof. Dr. med. (0049 22825710353, eleni.gkika@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-Year Event-Free Survival (EFS) Rate in Patients with Resectable or Borderline Resectable NSCLC (time frame: Within 2 years after date of randomization). 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 NCT06810609, 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 27 Jan 2026.

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