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New treatment option for Non Small Cell Lung Cancer
Official title A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.
ClinicalTrials.gov ID: NCT06284317
What this study is testing
What is Adjuvant durvalumab?
Adjuvant durvalumab is an investigational medicine, being studied as a potential treatment for non small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- ADOPT-lung is an international, multicentre, open-label randomised phase III trial. Protocol treatment consists of 3-4 cycles of neoadjuvant durvalumab in combination with platinum-based doublet chemotherapy, followed by surgery.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- for enrolment:
- Histologically confirmed NSCLC.
- Stage IIB-IIIB (T1-4 N0-2) according to 8th edition of the TNM staging system of lung cancer. Stage III assessment should include samples of lymph...
- Known PD-L1 status, as tested locally using a validated assay. To ensure comparability of results, it is strongly encouraged that PD-L1 testing is...
- Absence of EGFR mutation or ALK translocation, as tested locally.
You likely can't join if
- for enrolment:
- T4 with invasion of heart, great vessels, carina, trachea, oesophagus, or spine.
- Any previous or concurrent treatments for NSCLC.
- Any previous immunotherapy.
- Major surgical procedure (as per investigators assessment) within 28 days before enrolment.
- History of allogenic organ transplantation.
See the full eligibility criteria
- for enrolment:
- Histologically confirmed NSCLC.
- Stage IIB-IIIB (T1-4 N0-2) according to 8th edition of the TNM staging system of lung cancer. Stage III assessment should include samples of lymph nodes at levels 4, bilaterally, and level 7 to rule out stage IIIB N3...
- Known PD-L1 status, as tested locally using a validated assay. To ensure comparability of results, it is strongly encouraged that PD-L1 testing is done with the Ventana PD-L1 (SP263) assay.
- Absence of EGFR mutation or ALK translocation, as tested locally.
- Primary tumour resectable and functionally operable as assessed per local multidisciplinary tumour board (cardiac evaluation, pulmonary function and diffusion capacity, comorbidity).
- Adequate haematological function: Haemoglobin ≥90 g/L, Absolute neutrophil count (ANC) ≥1.0× 109/L, Platelet count ≥75× 109/L. \- Adequate renal function: Measured creatinine clearance (CL) \>40 mL/min or calculated CL...
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Age ≥18 at the time of enrolment.
- Body weight \>30 kg.
- Life expectancy of at least 12 weeks.
- Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test at screening before enrolment. Pregnancy test must be repeated...
- Written IC for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention. Eligibility Criteria for randomisation:
- Surgical resection must have been completed. Note: Participants who have had only had segmentectomy or wedge resections are not eligible for randomisation.
- Patients must have complete resection: R0 or R1 resection.
- Patients must be fit to receive adjuvant treatment with durvalumab.
- Patients must have no evidence of metastatic disease as assessed by CT scan.
- Documentation of pathological response as per local review must be available.
- for enrolment:
- T4 with invasion of heart, great vessels, carina, trachea, oesophagus, or spine.
- Any previous or concurrent treatments for NSCLC.
- Any previous immunotherapy.
- Major surgical procedure (as per investigators assessment) within 28 days before enrolment.
- History of allogenic organ transplantation.
- Active or prior documented autoimmune disease or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome...
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial...
- 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 durvalumab and of low potential risk for recurrence. Adequately...
- History of leptomeningeal carcinomatosis.
- History of active primary immunodeficiency.
- Active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HbsAg) or HBV core antibody (anti-HBc). Participants with a past or resolved HBV infection (defined as the...
- Known HIV infection that is not well-controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA load for 3 months, CD4+ count of 500 cell per mm3...
- 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...
- Known allergy or suspected hypersensitivity to durvalumab or its excipients.
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
- Female patients who are pregnant or in the period of lactation.
- Female patients of childbearing potential and sexually active men who are not willing to use a highly effective contraceptive method during the trial until at least 90 days after the last dose of protocol treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Camperdown, New South Wales, Australia
- Penrith, New South Wales, Australia
- St Leonards, New South Wales, Australia
- Woolloongabba, Queensland, Australia
- Bedford Park, South Australia, Australia
- Hobart, Tasmania, Australia
- Box Hill, Victoria, Australia
- Melbourne, Victoria, Australia
- Parkville, Victoria, Australia
- Nedlands, Western Australia, Australia
- Vienna, Austria
- Anderlecht, Belgium
- Antwerp, Belgium
- Talinn, Estonia
- Angers, France
- Bordeaux, France
- Le Mans, France
- Lyon, France
- Dublin, Ireland
- Alessandria, Italy
+ 19 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Camperdown, New South Wales, Australia; Penrith, New South Wales, Australia; St Leonards, New South Wales, Australia; Woolloongabba, Queensland, Australia; Bedford Park, South Australia, Australia; Hobart, Tasmania, Australia and 33 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.