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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
Trial Status: active
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
9 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 Criteria
All races, gender and ethnic groups are eligible for this study.
Exclusion Criteria
As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including active bleeding diseases, psychiatric illness/social situations), history of allogenic organ transplant, and/or substance abuse 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.
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.
History of another primary malignancy.
Spinal cord compression and unstable brain metastases, as defined by Protocol.
Clinically significant corneal disease.
Has active or uncontrolled hepatitis B or C virus infection, as defined by Protocol.
Known HIV infection that is not well controlled, as defined by Protocol.
Uncontrolled infection requiring i.v. antibiotics, antivirals or antifungals; suspected infections (eg, prodromal symptoms); or inability to rule out infections (participants with localised fungal infections of skin or nails are eligible).
Resting ECG with clinically abnormal findings, as defined by Protocol.
Uncontrolled or significant cardiac disease, 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.
Pulmonary embolism within 3 months of the study enrolment or has severe pulmonary function compromise. Prior/Concomitant Therapy
Prior exposure to any agent including an ADC containing a chemotherapeutic agent targeting topoisomerase I, TROP2-targeted therapy. Prior/Concurrent Clinical Study Experience
Participants with a known history of severe hypersensitivity reactions to either Dato-DXd and osimertinib or any excipients of Dato DXd and osimertinib or drugs with a similar chemical structure or class to DXd and osimertinib.
Additional locations may be listed on ClinicalTrials.gov for NCT06350097.
