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Clinical Trials in India / NCT06350097
Recruiting Phase 3

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

NCT06350097 · tracked via the Priya Life Science India tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2024-04-29
Last updated
2026-08-26

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

OsimertinibDatopotamab Deruxtecan

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)

Trial sites (167)

FacilityCityRegionStatus
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.

Official registry record

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.

View NCT06350097 on ClinicalTrials.gov ↗ ← All trials in India