Phase
Condition
Non-small Cell Lung Cancer
Treatment
Pemetrexed
Aumolertinib monotherapy
Nab paclitaxel
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Is at least 18 years of age (or the legal age of consent in the jurisdiction in whichthe study is taking place)
- Has pathologically confirmed NSCLC that is Stage IIIB, 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-TKIsensitivity-ex19del or L858R-either alone or in combination with other EGFR mutations (eg, G719X, exon 20 insertions, S7681, L861Q)
- Has Eastern Cooperative Oncology group performance status of 0, 1, or 2 at the time ofenrollment.
- Has adequate organ function at the time of enrollment.
- Has QTc interval of ≤ 470 ms
- Male participants must agree to use a highly effective method of contraception and torefrain from donating sperm while receiving study treatment
- Female participants are eligible to participate if not pregnant or breastfeeding, andat least one of the following conditions applies: is not of childbearing potential ORis of childbearing potential and using a highly effective contraceptive method whilereceiving study treatment AND agrees not to donate eggs (ova, oocytes) during thisperiod
- All female participants must have a negative serum or urine pregnancy test resultwithin 48 hours prior to initiation of study drug dosing
Exclusion
Exclusion Criteria:
- Is a candidate for curative intent therapy for the NSCLC diagnosis.
- Tumor has mixed small-cell and non-small-cell pathology.
- Has received prior systemic treatment for metastatic NSCLC. Prior chemotherapy orimmunotherapy is permitted, provided that it was used for treatment of locoregionalNSCLC as a component of curative intent therapy and administration was completed morethan 6 months ago.
- Has refractory nausea and vomiting, chronic gastrointestinal disease(s), inability toswallow the formulated product (percutaneous endoscopic gastrostomy tubeadministration may be allowed if tablets are not crushed), or a history of previoussignificant bowel resection-any of which would preclude adequate absorption ofaumolertinib or osimertinib.
- Has active or past medical history of interstitial lung disease, drug-inducedinterstitial lung disease or radiation pneumonitis that required steroid treatment
- Has evidence of active bacterial, viral, or fungal infection which would preclude safeenrollment, as assessed by the treating Investigator.
- Has significant concomitant condition, that in the Investigator's judgment wouldprevent the participant from receiving study treatment or being followed in thisstudy, or which otherwise renders the participant inappropriate for the study.
- For participants in the aumolertinib monotherapy and aumolertinib with chemotherapyarms, use of strong CYP3A4 inhibitors/inducers within 14 days before initial studydrug dosing and use of grapefruit-containing products within 72 hours before initialstudy drug dosing is prohibited.
- Has a history of prolonged QT syndrome or Torsades de Pointes
- Has any clinically important abnormalities in rhythm, conduction, or morphology ofresting ECG, including evidence of QT prolongation (QTc >470 ms for males and >480 msfor females) or has any factor, including any current medication(s), known to increasethe risk of QTc prolongation or the risk of arrhythmic events
- Hypersensitivity or allergy to aumolertinib or osimertinib or their excipients
Study Design
Connect with a study center
Highlands Oncology Group
Springdale, Arkansas 72762
United StatesSite Not Available
Memorial Cancer Institute
Hollywood, Florida 33021
United StatesSite Not Available
Memorial Cancer Institute
Pembroke Pines, Florida 33028
United StatesSite Not Available
QCCA - Mission Blood & Cancer
Des Moines, Iowa 50314
United StatesSite Not Available
Summit Health
Florham Park, New Jersey 07932
United StatesSite Not Available
SCRI - Tennessee Oncology PLLC- Chattanooga
Chattanooga, Tennessee 37404
United StatesSite Not Available
SCRI - Tennessee Oncology- Nashville
Nashville, Tennessee 37203
United StatesSite Not Available
Northwest Medical Specialties, PLLC
Tacoma, Washington 98405
United StatesSite Not Available

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