A Study to Investigate Safety and Efficacy of Osimertinib and Amivantamab in Participants With No… (NCT05801029) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study to Investigate Safety and Efficacy of Osimertinib and Amivantamab in Participants With Non-small Cell Lung Cancer With Common Epidermal Growth Factor Receptor Mutations
Hong Kong, Malaysia60 participantsStarted 2023-07-18
Plain-language summary
This study will assess the safety and efficacy of Osimertinib with Amivantamab as First-line Treatment in Participants with Epidermal Growth Factor Receptor Mutation-Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC).
Who can participate
Age range18 Years – 130 Years
SexALL
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Inclusion Criteria:
* Histologically or cytologically documented non-squamous NSCLC. NSCLC of mixed histology is allowed.
* Newly diagnosed locally advanced or metastatic NSCLC or recurrent non-squamous NSCLC, not amenable to curative surgery or radiotherapy.
* WHO PS of 0 to 1 with no deterioration over the 2 weeks prior to enrolment.
* Minimum life expectancy \> 12 weeks at Day 1.
* Confirmation by the local laboratory that the tumour harbours one of the 2 common EGFRm known to be associated with (Epidermal Growth Factor Receptor- Tyrosine Kinase Inhibitor) EGFR-TKI sensitivity.
* At least 1 lesion that can be accurately measured at baseline as ≥10 mm in the longest diameter with computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for accurate repeated measurements.
* Contraceptive use by males or females should be consistent with local regulations
Exclusion Criteria:
* Any evidence of diseases, history of allogenic organ transplant, which in the investigator's opinion makes it undesirable for the participant to participate in the study or would jeopardise compliance with protocol.
* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the osimertinib, or previous significant bowel resection that would preclude adequate absorption distribution, metabolism, or excretion of osimertinib.
* History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥2 y…
What they're measuring
1
Number of participants with adverse events (AEs)
Timeframe: From screening (Day-28) to survival follow up (Approximately 52 months after the first participant is dosed)
2
Progression Free Survival (PFS)
Timeframe: From date of first dose of study intervention until radiological disease progression or death due to any cause (Approximately 52 months after the first participant is dosed)