Lung Cancer Clinical Trial
Aumolertinib Alone and With Chemotherapy in Patients With EGFR-Mutant Non-Small Cell Lung Cancer
Summary
The purpose of this study is to evaluate the efficacy and safety of aumolertinib and chemotherapy versus aumolertinib alone, along with an osimertinib reference arm, in systemic treatment-naïve participants who have metastatic EGFR-mutant NSCLC and an ECOG PS of 0, 1, or 2.
Additional study details include the following:
The study duration will be approximately 5 years.
Participants can continue to receive treatment as long as they are judged by the Investigator to continue to receive clinical benefit in the absence of meeting the discontinuation criteria
Eligibility Criteria
Inclusion Criteria:
Is at least 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) and capable of complying with study procedures.
Has pathologically confirmed NSCLC that is Stage IIIB (for selected participants who are not candidates for curative approaches per the treating Investigator), metastatic (Stage IVA or IVB), or recurrent, and which is not amenable to curative intent therapy.
Tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity-ex19del or L858R-either alone or in combination with other EGFR mutations (eg, G719X, exon 20 insertions, S7681, L861Q), as identified by tissue or blood testing via a Clinical Laboratory Improvement Amendments of 1988 (CLIA)- certified laboratory.
Has ECOG PS of 0, 1, or 2 at the time of enrollment.
Has adequate organ function, as defined by all of the following:
AST and ALT ≤ 3 × ULN
TBIL ≤ 1.5 × ULN
CREAT ≤ 1.5 × ULN OR calculated Ccr ≥ 50 mL/min
ANC ≥ 1000 cells/mm3
HGB ≥ 8.0 g/dL
PLAT ≥ 100,000/mm3
Must meet all of the applicable requirements for pregnancy and contraception, as follows:
Female participants:
Is a woman of childbearing potential who:
Has a negative serum pregnancy test
Is not breastfeeding
Agree to use highly effective contraceptive measures while receiving study drug
Agree not to donate while receiving study drug
Is a woman of nonchildbearing potential (WONCBP) who:
Is surgically sterile
Male participants:
Agree to use a highly effective method of contraception
Agree to refrain from donating sperm for the same time period.
Exclusion Criteria:
Medical Conditions:
Has refractory nausea and vomiting, chronic gastrointestinal disease(s), inability to swallow the formulated product (or for selected participants, to receive it by PEG tube as noted below), or a history of previous significant bowel resection-any of which would preclude adequate absorption of aumolertinib or osimertinib.
Has an active diagnosis of interstitial lung disease or pneumonitis.
Has evidence of active bacterial, viral, or fungal infection
Prior/Concomitant Therapy:
Has received prior systemic treatment for metastatic NSCLC. Note: Prior chemotherapy or immunotherapy is permitted, provided that a) it was used for treatment of locoregional NSCLC as a component of curative intent therapy and b) administration was completed more than 6 months ago.
Is a candidate for curative intent therapy for the NSCLC diagnosis.
Tumor has mixed small-cell and non-small-cell pathology.
Meets any of the following cardiac criteria:
Has any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG, including evidence of QT prolongation (QTc >470 for males and >480 for females
Has any factor, including any current medication(s), known to increase the risk of QTc prolongation or the risk of arrhythmic events
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