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
Osimertinib: Osimertinib 80 mg administered orally once daily (QD).
Datopotamab Deruxtecan: Datopotamab Deruxtecan 6 mg/kg administered as an intravenous (i.v.) infusion every 3 weeks (q3w).
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
Age
1. Participant must be ≥ 18 years.
Type of Participant and Disease Characteristics
2. 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.
3. 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.
4. Participants must not have received prior EGFR TKIs or other systemic therapy for Stage IIIB, IIIC or IV NSCLC.
5. 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.
6. 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.
7. WHO performance status of 0 or 1.
8. 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.
9. Adequate bone marrow reserve and organ function before the first dose of study intervention.
Exclusion Criteria:
1. 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.
2. 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.
3. History of another primary malignancy.
4. Spinal cord compression and/or unstable brain metastases.
5. Clinically significant corneal disease.
6. Has active or uncontrolled hepatitis B or C virus infection, as defined by Protocol.
7. 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.
8. Has clinically severe pulmonary function compromise resulting from intercurrent pulmonary illnesses.
Primary outcome measure(s)
To demonstrate the superiority of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of Progression Free Survival (PFS) by BICR in all randomised participants. — It is anticipated that it will be performed approximately 3 years after the first participant is randomised. PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression).
Trial sites (167)
Facility
City
Region
Status
Research Site
Fountain Valley
California
Suspended
Research Site
Los Alamitos
California
Recruiting
Research Site
Los Angeles
California
Recruiting
Research Site
Los Angeles
California
Recruiting
Research Site
Orange
California
Recruiting
Research Site
San Diego
California
Recruiting
Research Site
Santa Monica
California
Recruiting
Research Site
Walnut Creek
California
Recruiting
Research Site
New Haven
Connecticut
Recruiting
Research Site
Washington D.C.
District of Columbia
Withdrawn
Research Site
Jacksonville
Florida
Recruiting
Research Site
Ocala
Florida
Recruiting
Research Site
Orange City
Florida
Recruiting
Research Site
Honolulu
Hawaii
Withdrawn
Research Site
Chicago
Illinois
Withdrawn
Research Site
Hinsdale
Illinois
Recruiting
Research Site
North Chicago
Illinois
Recruiting
Research Site
Fort Wayne
Indiana
Recruiting
Research Site
Bethesda
Maryland
Recruiting
Research Site
Detroit
Michigan
Recruiting
Research Site
Saint Paul
Minnesota
Recruiting
Research Site
Bridgeton
Missouri
Withdrawn
Research Site
St Louis
Missouri
Recruiting
Research Site
Las Vegas
Nevada
Recruiting
Research Site
Brooklyn
New York
Recruiting
Research Site
New York
New York
Recruiting
Research Site
Dallas
Texas
Withdrawn
Research Site
Houston
Texas
Recruiting
Research Site
Houston
Texas
Withdrawn
Research Site
Webster
Texas
Recruiting
Research Site
Woodway
Texas
Recruiting
Research Site
Fairfax
Virginia
Recruiting
Research Site
Fort Belvoir
Virginia
Recruiting
Research Site
Midlothian
Virginia
Recruiting
Research Site
Seattle
Washington
Withdrawn
Research Site
Tacoma
Washington
Recruiting
Research Site
Milwaukee
Wisconsin
Recruiting
Research Site
Camperdown
Australia
Recruiting
Research Site
Clayton
Australia
Recruiting
Research Site
Kogarah
Australia
Recruiting
+ 127 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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