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Looking for participantsPhase3

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.

Sponsor: ETOP IBCSG Partners Foundation

NCT ID: NCT06284317

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Adjuvant durvalumab (drug)
How long the study runs
Study runs about 62 months (dates as stated)
About the drug or intervention
Adjuvant durvalumab — drug: Durvalumab is given at a fixed dose of 1500 mg i.v.
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at whether adding durvalumab (a drug that helps the immune system fight cancer) after chemotherapy, durvalumab and surgery helps patients with early-stage non-small cell lung cancer that can be removed by an operation. Durvalumab is a type of immunotherapy.

Who can take part

  • Adults aged 18 or over with non-small cell lung cancer confirmed by tissue testing
  • Cancer at stage IIB to IIIB that can be removed by surgery, as judged by the patient's own medical team
  • Known PD-L1 status (a test on the cancer), tested locally
  • Cancer that does not have an EGFR mutation or ALK change
  • Good blood, kidney and liver function, and able to carry out normal daily activity (performance status 0-1)
  • Body weight over 30 kg and a life expectancy of at least 12 weeks
  • For the second stage of the trial: surgery completed with the whole tumour removed, fit for further durvalumab, no sign of spread on a CT scan, and records of how the tumour responded
  • Signed informed consent to take part

Who may not be able to

  • Any previous treatment for this lung cancer, including immunotherapy
  • Certain autoimmune or inflammatory conditions (some exceptions, such as stable thyroid problems or type 1 diabetes, may be allowed)
  • Tumours invading the heart, major blood vessels, windpipe, gullet or spine
  • Major surgery within 28 days before joining, or a previous organ transplant
  • Uncontrolled other illnesses, such as active infection, heart failure or lung disease
  • Another cancer in the last 5 years, with some exceptions such as treated skin cancer
  • Active hepatitis B or C infection (some past infections may be allowed)
  • HIV that is not well controlled
  • Use of immunosuppressive medicines within 14 days before starting, or a live vaccine within 30 days
  • Allergy to durvalumab, taking part in another drug trial, or pregnancy or breastfeeding
  • Women who can become pregnant, or sexually active men, not willing to use reliable contraception during the trial and for at least 90 days after the last dose

What taking part involves

  • • Chemotherapy together with durvalumab before surgery
  • • Surgery to remove the tumour
  • • Further durvalumab treatment after surgery for those who join the second stage of the trial

Time commitment: Not stated — ask the trial team about how many visits are needed and how long the trial lasts; taking part involves chemotherapy, durvalumab, surgery, CT scans, blood tests and signing a consent form.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
290
Started
2025-01-15
Last checked
2026-05

Plain English Summary

What is this study?

  • • Testing a new treatment for non small cell lung cancer
  • • Phase3 - 290 participants
  • • ADOPT-lung is an international, multicentre, open-label randomised phase III trial

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with non small cell lung cancer

Where?

  • • London - Barts Health NHS Trust
  • • London - Royal Marsden Hospital (Chelsea)
  • • London - Royal Marsden Hospital (Sutton)
  • • Maidstone - Maidstone and Tunbridge Wells NHS Trust
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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. Patients with R0 and R1 only resection will be randomised to receive either adjuvant durvalumab for 12 cycles (experimental arm) or observation (control arm). The primary objective of the study is to determine whether additional adjuvant immunotherapy with durvalumab after neoadjuvant chemo-immunotherapy has an effect on disease-free survival (DFS) in patients who do not achieve complete pathological response (pCR) as per local assessment according to the IASLC recommendations.

Non Small Cell Lung Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

PD-L1EGFRALKhave a negativeParticipants positivereaction is negativeCD4

Treatment history

Treatments you must have had:

  • ✓ a negative urinary or serum pregnancy test at screening
  • ✓ been completed
  • ✓ complete resection: R0 or R1 resection
  • ✓ no evidence of metastatic disease as assessed by CT scan

What the study is looking for

  • ✓Inclusion Criteria for enrolment:
  • ✓confirmed by a biopsy 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...
  • ✓T4 tumours will only be eligible if they are defined as T4 based only on their size (\>7cm); any other reason will...
See the full criteria
Inclusion 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 disease. T4 tumours will only be eligible if they are defined as T4 based only on their size (\>7cm); any other reason will be considered ineligible. * 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 \>40 mL/min calculated by the Cockcroft-Gault. \- Adequate liver function: ALT and AST ≤2.5× institutional ULN, Total serum bilirubin ≤1.5× institutional ULN (patients with Gilbert's syndrome may be allowed to be enrolled after consultation with the Medical Affairs Team at the ETOP IBCSG Partners Foundation. * 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 within 3 days before the first dose of protocol treatment. * 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. Exclusion Criteria 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 \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\]). The following are exceptions to this criterion: Patients with vitiligo or alopecia. Patients with type I diabetes. Patients with hypothyroidism (e.g., 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 may be included but only after consultation with the Medical Affairs Team at the ETOP IBCSG Partners Foundation. 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, interstitial lung disease (ILD), or serious chronic gastrointestinal conditions associated with diarrhoea. * 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 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 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 presence of anti-HBc and absence of HbsAg) are eligible. Participants positive for HCV antibody are only eligible if polymerase chain reaction is negative for HCV RNA. * 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, no history of AIDS-defining opportunistic infection within the past 12 months, and stable for at least 3 months on the same anti-HIV medication. * 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 exceeding 10 mg/day of prednisone or its equivalent. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication). \- Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab. Note: Patients in the ADOPT-lung trial, should not receive live vaccine whilst receiving durvalumab and for up to 30 days after the last dose. Concurrent enrolment in another interventional clinical trial. * 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.

Where Is This Study? (5 UK sites)

Barts Health NHS Trust

London, United Kingdom

Recruiting
Site contact (verified)
Adam Januszewskiadam.januszewski@nhs.net

Royal Marsden Hospital (Chelsea)

London, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)

Royal Marsden Hospital (Sutton)

London, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)

Maidstone and Tunbridge Wells NHS Trust

Maidstone, United Kingdom

Recruiting
Site contact (verified)

Wythenshawe Hospital, Manchester University NHS Foundation Trust

Manchester, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Heidi Roschitzki, PhD

Sponsor contact

CONTACT

+41 31 511 94 00 heidi.roschitzki@etop.ibcsg.org

Susanne Roux

Sponsor contact

CONTACT

+41 31 511 94 00 ADOPT-lung@etop.ibcsg.org
Data sourced from ClinicalTrials.gov · Last verified: 2026-05