Aumolertinib With Chemotherapy or Alone Compared With Osimertinib in Patients With Epidermal Growth Factor Receptor-Mutant Non-Small Cell Lung Cancer

Last updated: April 9, 2024
Sponsor: EQRx International, Inc.
Overall Status: Terminated

Phase

3

Condition

Non-small Cell Lung Cancer

Treatment

Pemetrexed

Aumolertinib monotherapy

Nab paclitaxel

Clinical Study ID

NCT05493501
EQ143-301
2022-002674-93
  • Ages > 18
  • All Genders

Study Summary

Aumolertinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets EGFR mutations. The reason for this study is to learn whether adding chemotherapy to a new investigational drug called aumolertinib helps to slow or stop cancer growth in people with EGFR mutation-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC). The study will compare this new combination of drugs to osimertinib, given alone. Aumolertinib given alone will also be used in the study, and it will be looked at in comparison with osimertinib given alone.

This is a randomized, open-label study with 3 different groups that are listed below. "Randomized" means the study treatment participants take will be chosen by chance (decided at random by a computer). "Open-label" means that the participant, the study doctor, and the Sponsor will know which study treatment each participant is receiving.

Participants will be randomly assigned to one of the following 3 treatment groups:

  • Group 1: Treatment with aumolertinib alone, taken orally (by mouth) as a pill once a day. Around 100 participants will be randomly assigned to this group.

  • Group 2: Treatment with aumolertinib taken orally as a pill once a day, in combination with chemotherapy given intravenously (IV; through a needle placed in a vein) on the schedule provided by the study doctor. Around 200 participants will be randomly assigned to this group.

  • Group 3: Treatment with osimertinib alone, taken orally as a pill once a day. Around 200 participants will be randomly assigned to this group.

Because there will be twice as many participants in Group 2 and Group 3 as in Group 1, the chance of a participant being randomly assigned to either of those groups is twice as likely as being assigned to Group 1.

Participants can continue to receive study treatment as long as they have not withdrawn consent, as long as they choose to continue to receive study treatment and are judged by their doctor to continue to receive clinical benefit from receiving the study treatment, and as long as no other study treatment and/or study discontinuation criteria are met .

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Is at least 18 years of age (or the legal age of consent in the jurisdiction in whichthe study is taking place)
  2. Has pathologically confirmed NSCLC that is Stage IIIB, metastatic (Stage IVA or IVB),or recurrent, and which is not amenable to curative intent therapy.
  3. 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)
  4. Has Eastern Cooperative Oncology group performance status of 0, 1, or 2 at the time ofenrollment.
  5. Has adequate organ function at the time of enrollment.
  6. Has QTc interval of ≤ 470 ms
  7. Male participants must agree to use a highly effective method of contraception and torefrain from donating sperm while receiving study treatment
  8. 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
  9. 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:

  1. Is a candidate for curative intent therapy for the NSCLC diagnosis.
  2. Tumor has mixed small-cell and non-small-cell pathology.
  3. 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.
  4. 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.
  5. Has active or past medical history of interstitial lung disease, drug-inducedinterstitial lung disease or radiation pneumonitis that required steroid treatment
  6. Has evidence of active bacterial, viral, or fungal infection which would preclude safeenrollment, as assessed by the treating Investigator.
  7. 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.
  8. 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.
  9. Has a history of prolonged QT syndrome or Torsades de Pointes
  10. 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
  11. Hypersensitivity or allergy to aumolertinib or osimertinib or their excipients

Study Design

Total Participants: 8
Treatment Group(s): 8
Primary Treatment: Pemetrexed
Phase: 3
Study Start date:
December 14, 2022
Estimated Completion Date:
August 31, 2023

Connect with a study center

  • Highlands Oncology Group

    Springdale, Arkansas 72762
    United States

    Site Not Available

  • Memorial Cancer Institute

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Memorial Cancer Institute

    Pembroke Pines, Florida 33028
    United States

    Site Not Available

  • QCCA - Mission Blood & Cancer

    Des Moines, Iowa 50314
    United States

    Site Not Available

  • Summit Health

    Florham Park, New Jersey 07932
    United States

    Site Not Available

  • SCRI - Tennessee Oncology PLLC- Chattanooga

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • SCRI - Tennessee Oncology- Nashville

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington 98405
    United States

    Site Not Available

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