Non-small Cell Lung Cancer study: Osimertinib vs Datopotamab Deruxtecan
Official 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
ClinicalTrials.gov ID: NCT06350097
What this study is testing
What is Osimertinib?
An investigational oral medicine being studied as a potential first‑line treatment for EGFR‑mutated non‑small cell lung cancer. It is designed to block the activity of mutant epidermal growth factor receptor (EGFR) proteins that drive cancer cell growth.
Also referred to as Tagrisso, AZD9291.
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
- The study compares the safety and effectiveness of Osimertinib alone versus Osimertinib plus Dato‑DXD in people whose lung cancer has EGFR mutations.
- Who it's for
- Adults with locally advanced or metastatic non‑small cell lung cancer that has EGFR mutations (Ex19del or L858R).
- What's involved
- Participants take the Osimertinib pill daily and may receive Dato‑DXD by IV infusion. They have clinic visits every 3 weeks for treatment and assessments, with additional visits every 6 weeks from week 7 to week 17 and then every 12 weeks if on Osimertinib alone.
- Time commitment
- The study can last up to about 8 years, but participants stay in the study until the cancer progresses, side effects become too severe, or other stopping rules apply. Visits are scheduled every 3 weeks during treatment, with longer intervals after week 17 if on Osimertinib alone.
- 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
- 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.
- 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...
- 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...
You likely can't join if
- As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including active bleeding diseases...
- Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated product, or previous significant bowel...
- History of another primary malignancy.
- Spinal cord compression and/or unstable brain metastases.
- Clinically significant corneal disease.
- Has active or uncontrolled hepatitis B or C virus infection, as defined by Protocol.
See the full eligibility criteria
- 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.
- 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...
- 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...
- Adequate bone marrow reserve and organ function before the first dose of study intervention.
- 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...
- 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...
- History of another primary malignancy.
- Spinal cord compression and/or unstable brain metastases.
- 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...
- Has clinically severe pulmonary function compromise resulting from intercurrent pulmonary illnesses.
The study team makes the final eligibility decision.
Where it is enrolling
- Los Alamitos, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- San Diego, California, United States
- Santa Monica, California, United States
- Walnut Creek, California, United States
- New Haven, Connecticut, United States
- Jacksonville, Florida, United States
- Ocala, Florida, United States
- Orange City, Florida, United States
- Hinsdale, Illinois, United States
- North Chicago, Illinois, United States
- Fort Wayne, Indiana, United States
- Bethesda, Maryland, United States
- Detroit, Michigan, United States
- Saint Paul, Minnesota, United States
- St Louis, Missouri, United States
- Las Vegas, Nevada, United States
- Brooklyn, New York, United States
- New York, New York, United States
+ 97 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, but 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?
This study is enrolling now at Los Alamitos, California, United States; Los Angeles, California, United States; Orange, California, United States; San Diego, California, United States; Santa Monica, California, United States; Walnut Creek, California, United States and 111 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.