Tests osimertinib with or without datopotamab deruxtecan as first treatment for lung cancer
Tests two medicines together in adults with EGFR-mutated advanced lung cancer.
Plain-language title generated from the registry record
Registry title: Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer
Key facts
- Where
- Bydgoszcz, Olsztyn, Poznan, Warsaw, and Wilkowice, PolandSee the 5 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with EGFR-mutation-positive non-squamous non-small cell lung cancer that is locally advanced or has spread and who have not yet had treatment for it. It compares osimertinib alone with osimertinib plus Dato-DXd.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Non-squamous non-small cell lung cancer, stage IIIB, IIIC or IV, or coming back, that cannot be removed by surgery or treated with full chemoradiation.
- Earlier treatment
- No earlier EGFR TKI or other drug treatment for stage IIIB, IIIC or IV lung cancer.
- Biomarker or test result
- The tumour has an EGFR mutation, Ex19del or L858R, alone or with other gene changes. An archived tumour sample must be provided.
Main reasons for not taking part
- Another primary cancer in the past
- Spinal cord compression or unstable brain metastases
- History of interstitial lung disease or pneumonitis
- Active or uncontrolled hepatitis B or C infection
- Clinically significant corneal disease
Read by machine on 9 November 2026.
Where in Poland
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W BydgoszczyBydgoszcz, PolandNo longer taking part
- Warminsko-Mazurskie Centrum Chorob Pluc w OlsztynieOlsztyn, PolandNo longer taking part
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza ZeylandowPoznan, PolandNo longer taking part
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyWarsaw, PolandNo longer taking part
- Centrum Pulmonologii I Torakochirurgii W BystrejWilkowice, PolandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT06350097EU 2023-509883-89-00
- Record updated
- 26 August 2026
- Original description
The purpose of this study is to evaluate efficacy and safety of osimertinib (tablet) in combination with Dato-DXd (i.v. infusion) compared with osimertinib (tablet) monotherapyas a first-line therapy in participants with locally advanced or metastatic EGFRm (Ex19del and/or L858R) NSCLC.Read full original descriptionShow less
A Phase III, Open-label, Randomised Study of Osimertinib With or Without Datopotamab Deruxtecan (Dato-DXd), as First-line Treatment in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation-positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer
The purpose of this study is to evaluate efficacy and safety of osimertinib (tablet) in combination with Dato-DXd (i.v. infusion) compared with osimertinib (tablet) monotherapyas a first-line therapy in participants with locally advanced or metastatic EGFRm (Ex19del and/or L858R) NSCLC.
Study details include:
1. The study duration will be event-driven, with an estimated duration of approximately 8 years. 2. Participants may receive study treatment until disease progression, unacceptable toxicity, or other specific discontinuation criteria are met. 3. The visit frequency will be every 3 weeks during the treatment period.
Note: Participants on osimertinib treatment(osimertinib only arm or who have discontinued Dato-DXd while are still receiving osimertinib) are required to attend visits to perform assessments every 6 weeks from Cycle 7 until Cycle 17 and then visits every 12 weeks until disease progression or IP discontinuation. Participants who are receiving osimertinib + Dato-DXd are still required to attend visit to perform assessment every 3 weeks (q3w) per SoA.
Inclusion: Age; Participant must be ≥ 18 years; Type of Participant and Disease Characteristics; Histologically or cytologically documented nonsquamous NSCLC. NSCLC of mixed histology is allowed if adenocarcinoma is the predominant histology. Mixed small-cell lung cancer and NSCLC histology, and sarcomatoid variant of NSCLC is ineligible; Stage IIIB or IIIC or Stage IV metastatic NSCLC or recurrent NSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative surgery or definitive chemoradiation at the time of randomisation; Participants must not have received prior EGFR TKIs or other systemic therapy for Stage IIIB, IIIC or IV NSCLC; The tumour harbors at least 1 of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del or L858R), either alone or in combination with other genomic alterations, which may include EGFR T790M, assessed by a CLIA-certified (US sites) or an accredited (outside of the US) local laboratory or by central prospective tissue testing; For participants enrolled in randomisation period, mandatory provision of an unstained, archival tumour tissue sample in a quantity sufficient to allow for central confirmation of the EGFR mutation status; WHO performance status of 0 or 1; At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with CT or MRI and is suitable for accurate repeated measurements; Adequate bone marrow reserve and organ function before the first dose of study intervention.
Exclusion: Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of osimertinib; As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including active bleeding diseases, history of allogenic organ transplant which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol; History of another primary malignancy; Clinically significant corneal disease; Has active or uncontrolled hepatitis B or C virus infection, as defined by Protocol; Past medical history of ILD/penumonitis, including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening; Has clinically severe pulmonary function compromise resulting from intercurrent pulmonary illnesses; Spinal cord compression and/or unstable brain metastases.