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NSCLC, Stage IIIPhase 2DEDALUSNCT05128630

Chemo-immunotherapy, Hypo-fractionated RT and Maintenance Immunotherapy for Stage III NSCLC.

A Phase 2 study testing Durvalumab in people with NSCLC, Stage III, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Aim of this phase 2 study is to evaluate the safety and the efficacy of the combination of induction chemotherapy plus durvalumab followed by reduced-dose hypo-fractionated thoracic RT (concurrent with durvalumab) and durvalumab maintenance for stage 3 unresectable NSCLC patients candidate to sequential chemo-RT. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC, Stage III
What is being tested?
Durvalumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteItaly
Study dates
28 Oct 2021to 28 Nov 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  • Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses.
  • Age
  • 18 years or older at the time of signing the ICF. Type of patient and disease characteristics
  • Histologically- or cytologically-documented NSCLC with locally-advanced, unresectable Stage III disease (according to the IASLC Staging Manual Version 8 [IASLC 2016]). Positron emission tomography (PET)/CT, MRI of the brain, and endobronchial ultrasound with biopsy are highly encouraged at diagnosis.
  • Patients with measurable disease assessed at baseline by CT/MRI will be entered in this study.
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  • Must have a life expectancy of at least 12 weeks at enrolment.
  • WHO/ECOG PS 0-1.
  • Patient not eligible for concurrent chemo radiation according to investigator assessment
  • Adequate organ and marrow function at enrollment as defined below. These parameters should be achieved without augmentation by growth factors, transfusions, or infusions within 28 days of screening unless required for SoC:
  • Haemoglobin ≥9.0 g/dL;
  • Absolute neutrophil count >1.0 × 109/L;
  • Platelet count >75 × 109/L;
  • Serum bilirubin ≤1.5 × upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome, who will be allowed in consultation with their physician.
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN.
  • Measured creatinine clearance >40 mL/min or calculated creatinine clearance >40 mL/min as determined by Cockcroft-Gault (using actual body weight) (Cockcroft and Gault 1976).
  • Males:
  • Creatinine clearance (mL/min) = [Weight (kg) × (140 - Age)] / 72 × serum creatinine (mg/dL)
  • Females:
  • Creatinine clearance (mL/min) = [Weight (kg) × (140 - Age) × 0.85] / 72 × serum creatinine (mg/dL)
  • Body weight >30 kg at enrollment
  • Male or female. Reproduction
  • 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:
  • Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
  • Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
  • Exclusion Criteria:Patients should not enter the study if any of the following exclusion criteria are fulfilled:
  • Patients who have disease considered for surgical treatment as part of their care plan, such as Pancoast or superior sulcus tumors.
  • Mixed small-cell lung cancer and NSCLC histology.
  • History of allogeneic organ transplantation.
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, 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:
  • Patients with vitiligo or alopecia.
  • Patients with hypothyroidism (eg, 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 at enrolment may be included but only after consultation with the Study Physician.
  • Patients with celiac disease controlled by diet alone.
  • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, ILD, serious chronic GI conditions associated with diarrhoea, 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 except for:
  • Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence.
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
  • Adequately treated carcinoma in situ without evidence of disease.
  • History of leptomeningeal carcinomatosis.
  • History of active primary immunodeficiency.
  • Active infection including hepatitis B (known positive hepatitis B surface antigen [HbsAg] result), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies). Patients with a past or resolved hepatitis B virus (HBV) infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HbsAg) are eligible. Patients positive for hepatitis C antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA).
  • Any unresolved toxicity of NCI CTCAE Grade ≥2 from previous anticancer therapy 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.
  • Known allergy or hypersensitivity to durvalumab or any of the IP excipients. Prior/concomitant therapy
  • Prior chemo-radiotherapy for lung cancer. Prior surgical resection (ie, Stage I or II) is permitted.
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
  • Note: Patients, if enrolled, should not receive live vaccine while receiving IP and up to 30 days after the last dose of IP.
  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Alessandra Ferrari, dr. contact

+390382503689

alessandra.ferrari@smatteo.pv.it

Italy1 site, 1 recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

    Alessandra Ferrari, dr., +390382503689, alessandra.ferrari@smatteo.pv.it

    Andrea Riccardo Filippi, MD

    Recruiting

Other trials in Italy

About this study

Official title: An Open-label, Multi-center, Phase 2 Study of Chemo-immunotherapy Followed by Reduced-dose Hypo-fractionated RT and Maintenance Immunotherapy for Stage III Unresectable Non -Small-cell Lung Carcinoma (NSCLC).

Aim of this phase 2 study is to evaluate the safety and the efficacy of the combination of induction chemotherapy plus durvalumab followed by reduced-dose hypo-fractionated thoracic RT (concurrent with durvalumab) and durvalumab maintenance for stage 3 unresectable NSCLC patients candidate to sequential chemo-RT.

Read the detailed description

The study hypothesis is that the new regimen tested in this study will be safe and effective by:

  1. anticipating the use of durvalumab, together with chemotherapy (higher efficacy)
  2. harnessing response to induction chemo-durvalumab (which is expected to be significant) to be able to reduce radiotherapy dose without reducing tumor control probability
  3. reducing radiation-induced immunosuppression
  4. reducing radiation-induced late morbidity, this aspect is important when considering that this regimen is expected to be able to cure a proportion of patients (long-term survivors)

In this phase II study, the investigators will evaluate the combination of induction chemotherapy plus durvalumab followed by reduced-dose hypo-fractionated thoracic RT (concurrent with durvalumab) and durvalumab maintenance for stage 3 unresectable NSCLC patients candidate to sequential chemo-RT.

Being tested
Durvalumab
Keywords
durvalumab, radiotherapy, immunotherapy
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

    Also called radotherapy, chemotherapy

    Patients will receive 1500 mg durvalumab via IV infusion q3w concomitant with chemotherapy (Cisplatin/carboplatin plus etoposide) for up to a maximum of 3 cycles, then via IV infusion at the same interval during sequential radiotherapy and then every 4 weeks for up to a maximum of 12 months or until confirmed disease progression, unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.

Study groups in NCT05128630
Study groupRoleWhat they receive
Single-armExperimentalChemotherapy plus durvalumab, hypofractionated RT plus durvalumab, durvalumab maintenance
Receives: Drug: Durvalumab

What is being measured

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

  1. Safety

    Incidence of Grade 3 or more possibly related adverse events (PRAEs)

    Measured: Within 6 months from study enrollment

Secondary outcomes (2)

  1. Progression-Free Survival

    Kaplan-Meier Progression-Free Survival, according to RECIST 1.1 and as assessed by the Investigators

    Measured: 0-36 months from study enrollment

  2. Overall Survival

    Kaplan-Meier Overall Survival

    Measured: 0-36 months from study enrollment

Timeline

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

  1. First posted22 Nov 2021
  2. Study start28 Oct 2021
  3. Primary completion28 Nov 2024 (estimated)
  4. Study completion28 Nov 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
Not applicable
Intervention model
Single group
Model description
open-label, multi-center, single arm phase 2 trial
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05128630
Sponsor's protocol ID
20210040686
Acronym
DEDALUS
Status last verified
Sep 2023
First submitted
28 Oct 2021
Last updated
28 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Agustoni F, Saddi J, Cortinovis DL, Arcangeli S, Sala L, Klersy C, Musella V, Galli G, Borgetto SMC, Stella GM, Cicognini D, Ferrari A, Pedrazzoli P, Grossi F, Filippi AR. Sequential chemo-durvalumab, reduced-dose RT, and consolidation durvalumab for unresectable stage III NSCLC unfit for PACIFIC regimen (DEDALUS trial). JNCI Cancer Spectr. 2026 May 9;10(3):pkag050. doi: 10.1093/jncics/pkag050.

    PubMed 42093085

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab in people with NSCLC, Stage III, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.

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 52 inclusion and 0 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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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 Alessandra Ferrari, dr. (+390382503689, alessandra.ferrari@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (time frame: Within 6 months from study enrollment). 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 NCT05128630, 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 28 Sep 2023.

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