NSCLCPhase 3NCT05493501
Aumolertinib With Chemotherapy or Alone Compared With Osimertinib in Patients With Epidermal Growth Factor Receptor-Mutant Non-Small Cell Lung Cancer
A Phase 3 study testing Aumolertinib monotherapy, Osimertinib monotherapy and Pemetrexed in people with NSCLC, run by EQRx International, Inc. at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Aumolertinib monotherapy, Osimertinib monotherapy and Pemetrexed
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 8 sitesUnited States
- Study dates
- 14 Dec 2022to 31 Aug 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is at least 18 years of age (or the legal age of consent in the jurisdiction in which the 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-TKI sensitivity-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 of enrollment.
- Has adequate organ function at the time of enrollment.
- Has QTc interval of ≤ 470 ms
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- Male participants must agree to use a highly effective method of contraception and to refrain from donating sperm while receiving study treatment
- Female participants are eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies: is not of childbearing potential OR is of childbearing potential and using a highly effective contraceptive method while receiving study treatment AND agrees not to donate eggs (ova, oocytes) during this period
- All female participants must have a negative serum or urine pregnancy test result within 48 hours prior to initiation of study drug dosing
Who cannot join
- 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 or immunotherapy is permitted, provided that it was used for treatment of locoregional NSCLC as a component of curative intent therapy and administration was completed more than 6 months ago.
- Has refractory nausea and vomiting, chronic gastrointestinal disease(s), inability to swallow the formulated product (percutaneous endoscopic gastrostomy tube administration may be allowed if tablets are not crushed), or a history of previous significant bowel resection-any of which would preclude adequate absorption of aumolertinib or osimertinib.
- Has active or past medical history of interstitial lung disease, drug-induced interstitial lung disease or radiation pneumonitis that required steroid treatment
- Has evidence of active bacterial, viral, or fungal infection which would preclude safe enrollment, as assessed by the treating Investigator.
Show all 11Show fewer
- Has significant concomitant condition, that in the Investigator's judgment would prevent the participant from receiving study treatment or being followed in this study, or which otherwise renders the participant inappropriate for the study.
- For participants in the aumolertinib monotherapy and aumolertinib with chemotherapy arms, use of strong CYP3A4 inhibitors/inducers within 14 days before initial study drug dosing and use of grapefruit-containing products within 72 hours before initial study 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 of resting ECG, including evidence of QT prolongation (QTc >470 ms for males and >480 ms for females) or has any factor, including any current medication(s), known to increase the risk of QTc prolongation or the risk of arrhythmic events
- Hypersensitivity or allergy to aumolertinib or osimertinib or their excipients
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
SCRI - Tennessee Oncology PLLC- Chattanooga
Chattanooga, Tennessee, 37404
QCCA - Mission Blood & Cancer
Des Moines, Iowa, 50314
Summit Health
Florham Park, New Jersey, 07932
Memorial Cancer Institute
Hollywood, Florida, 33021
SCRI - Tennessee Oncology- Nashville
Nashville, Tennessee, 37203
Memorial Cancer Institute
Pembroke Pines, Florida, 33028
Highlands Oncology Group
Springdale, Arkansas, 72762
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405
About this study
Official title: A Randomized, Three-Arm, Open-Label Phase 3b Clinical Trial of Aumolertinib, Versus Aumolertinib With Chemotherapy, Versus Osimertinib for Patients With Metastatic NSCLC and an EGFR Mutation (TREBLE)
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.
Read more
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 .
- Conditions
- NSCLC
- Being tested
- Aumolertinib monotherapy, Osimertinib monotherapy, Pemetrexed, Cisplatin, Carboplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aumolertinib monotherapyDrug
Also called EQ143, HS-10296
Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.
Osimertinib monotherapyDrug
Also called Tagrisso
80 mg tablet administered orally, once daily
PemetrexedDrug
Also called Alimta
Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy
CisplatinDrug
Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information.
CarboplatinDrug
Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information.
PaclitaxelDrug
Also called Taxol
Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information.
Nab paclitaxelDrug
Also called Abraxane, Albumin-bound paclitaxel
Administered by IV Infusion given over 4 fixed cycles per prescribing information.
GemcitabineDrug
Also called Gemzar
Administered by IV Infusion over 4 fixed cycles per prescribing information.
| Study group | Role | What they receive |
|---|---|---|
| Aumolertinib monotherapy | Experimental | Not described Receives: Drug: Aumolertinib monotherapy |
| Aumolertinib + platinum-based doublet chemotherapy | Experimental | For adenocarcinoma, either:
* Aumolertinib + cisplatin with pemetrexed, or
* Aumolertinib + carboplatin with pemetrexed
For squamous cell carcinoma, one of the following:
* Aumolertinib + cisplatin or carboplatin with paclitaxel;
* Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or
* Aumolertinib + cisplatin or carboplatin with gemcitabine Receives: Drug: Aumolertinib monotherapy; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab paclitaxel; Drug: Gemcitabine |
| Osimertinib monotherapy | Active comparator | Not described Receives: Drug: Osimertinib monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
PFS is defined as the time from date of randomization until date of disease progression or death due to any cause, whichever occurs first.
Measured: Up to 5 years
Secondary outcomes (20)
Overall Survival (OS)
OS is defined as the time from date of randomization until death from any cause.
Measured: Up to 6 years
Objective Response Rate (ORR) as Assessed by BICR Per RECIST v1.1
ORR is defined as proportion of participants who achieve a complete response or partial response at any time before progressive disease or initiating a subsequent anticancer therapy.
Measured: Up to 5 years
Disease Control Rate (DCR) as Assessed by BICR Per RECIST v1.1
DCR is defined as the proportion of participants who have a best overall response of complete response or partial response or stable disease.
Measured: Up to 5 years
Tumor Growth Rate (TGR) as Assessed by BICR Per RECIST v1.1
TGR is defined as the constant exponential growth rate estimated using the sum of longest diameters based on radiological tumor assessment per RECIST v1.1.
Measured: Up to 5 years
Duration of Response (DOR) as Assessed by BICR Per RECIST v1.1
DOR is defined as date of first response (complete response or partial response) until date of disease progression or death due to any cause, whichever occurs first
Measured: Up to 5 years
Depth of Response (DepOR) as Assessed by BICR Per RECIST v1.1
DepOR is defined as the relative change in target lesion tumor size (calculated as the sum of the longest diameters of the target lesions, in the absence of new lesions or progression of nontarget lesions) as compared to baseline.
Measured: Up to 5 years
PFS as Assessed by the Investigator Per RECIST v1.1
PFS is defined as the time from date of randomization until date of disease progression or death due to any cause, whichever occurs first.
Measured: Up to 5 years
ORR as Assessed by the Investigator Per RECIST v1.1
ORR is defined as the proportion of participants who achieve a complete response or partial response at any time before disease progression or initiating a subsequent anticancer therapy.
Measured: Up to 5 years
DCR as Assessed by the Investigator Per RECIST v1.1
DCR is defined as the proportion of participants who have a best overall response of complete response or partial response or stable disease.
Measured: Up to 5 years
TGR as Assessed by the Investigator Per RECIST v1.1
TGR is defined as the constant exponential growth rate estimated using the sum of longest diameters based on radiological tumor assessment per RECIST v1.1.
Measured: Up to 5 years
DOR as Assessed by the Investigator Per RECIST v1.1
DOR is defined as date of first response (complete response or partial response) until the date of disease progression or death due to any cause, whichever occurs first.
Measured: Up to 5 years
DepOR as Assessed by the Investigator Per RECIST v1.1
DepOR is defined as the relative change in target lesion tumor size (calculated as the sum of the longest diameters of the target lesions, in the absence of new lesions or progression of nontarget lesions) as compared to baseline.
Measured: Up to 5 years
Quality of Life as Assessed by the National Cancer Institute Patient Reported Outcomes Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE) Questionnaire
NCI PRO-CTCAE questionnaire responses are scored from 0 to 4, wherein lower values represent a better outcome. For this trial, the burden of symptoms that will be captured by this questionnaire comprises nausea, diarrhea, and rash.
Measured: Up to 5 years
Rate of Circulating Tumor DNA (ctDNA) Clearance
ctDNA clearance is defined as when a detectable EGFR mutation in ctDNA at baseline becomes undetectable or drops below a predetermined threshold. Rate of ctDNA clearance is defined as 100 × number of participants who are ctDNA-negative at 6 weeks divided by number of participants who are ctDNA-positive at baseline.
Measured: 6 weeks
Plasma Concentration of Aumolertinib
Plasma concentration is defined as the measured drug concentration of aumolertinib.
Measured: Up to approximately 5 months
Plasma Concentration of Aumolertinib Metabolite
Plasma concentration is defined as the measured drug concentration of aumolertinib metabolite.
Measured: Up to approximately 5 months
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
This outcome will evaluate the incidence of participants with TEAEs, graded according to NCI CTCAE V5.
Measured: From date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), up to 5 years
Number of Participants With Serious Adverse Events (SAEs)
This outcome will evaluate incidence of participants with SAEs, be graded according to NCI CTCAE V5.
Measured: From date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), up to 5 years
Number of Participants With Electrocardiogram (ECG) Abnormalities
This outcome will evaluate incidence of participants with ECG abnormalities
Measured: From date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), up to 5 years
Number of Participants With Laboratory Abnormalities
This outcome will evaluate incidence of participants with laboratory abnormalities, graded according to NCI CTCAE V5.
Measured: From date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start14 Dec 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Why it stopped: The study is being closed based on corporate changes at EQRx and is not related to any efficacy or safety issues with aumolertinib.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- EQRx International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493501
- Sponsor's protocol ID
- EQ143-301
- Other IDs
- 2022-002674-93
- Status last verified
- Oct 2023
- First submitted
- 24 Jun 2022
- Last updated
- 2 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Three-Arm, Open-Label Phase 3b Clinical Trial of Aumolertinib, Versus Aumolertinib With Chemotherapy, Versus Osimertinib for Patients With Metastatic NSCLC and an EGFR Mutation (TREBLE)
- ClinicalTrials.gov ID
- NCT05493501
- Acronym / sponsor ID
- EQ143-301
- Conditions
- NSCLC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study is being closed based on corporate changes at EQRx and is not related to any efficacy or safety issues with aumolertinib.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- EQRx International, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 9 Aug 2022 (actual)
- Results
- Posted 2 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aumolertinib monotherapy | Experimental | Drug: Aumolertinib monotherapy |
| Aumolertinib + platinum-based doublet chemotherapy | Experimental | Drug: Aumolertinib monotherapy, Drug: Pemetrexed, Drug: Cisplatin, Drug: Carboplatin, Drug: Paclitaxel, Drug: Nab paclitaxel, Drug: GemcitabineFor adenocarcinoma, either: * Aumolertinib + cisplatin with pemetrexed, or * Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: * Aumolertinib + cisplatin or carboplatin with paclitaxel; * Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or * Aumolertinib + cisplatin or carboplatin with gemcitabine |
| Osimertinib monotherapy | Active comparator | Drug: Osimertinib monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Is at least 18 years of age (or the legal age of consent in the jurisdiction in which the 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-TKI sensitivity-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 of enrollment.
- Has adequate organ function at the time of enrollment.
Key exclusion criteria (11 listed)
- 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 or immunotherapy is permitted, provided that it was used for treatment of locoregional NSCLC as a component of curative intent therapy and administration was completed more than 6 months ago.
- Has refractory nausea and vomiting, chronic gastrointestinal disease(s), inability to swallow the formulated product (percutaneous endoscopic gastrostomy tube administration may be allowed if tablets are not crushed), or a history of previous significant bowel resection-any of which would preclude adequate absorption of aumolertinib or osimertinib.
- Has active or past medical history of interstitial lung disease, drug-induced interstitial lung disease or radiation pneumonitis that required steroid treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aumolertinib monotherapyAlso: EQ143, HS-10296Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. | Drug | Aumolertinib + platinum-based doublet chemotherapy, Aumolertinib monotherapy |
| Osimertinib monotherapyAlso: Tagrisso80 mg tablet administered orally, once daily | Drug | Osimertinib monotherapy |
| PemetrexedAlso: AlimtaAdministered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy | Drug | Aumolertinib + platinum-based doublet chemotherapy |
| CisplatinAdministered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. | Drug | Aumolertinib + platinum-based doublet chemotherapy |
| CarboplatinAdministered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. | Drug | Aumolertinib + platinum-based doublet chemotherapy |
| PaclitaxelAlso: TaxolAdministered by IV Infusion given over 4 -6 fixed cycles per prescribing information. | Drug | Aumolertinib + platinum-based doublet chemotherapy |
| Nab paclitaxelAlso: Abraxane, Albumin-bound paclitaxelAdministered by IV Infusion given over 4 fixed cycles per prescribing information. | Drug | Aumolertinib + platinum-based doublet chemotherapy |
| GemcitabineAlso: GemzarAdministered by IV Infusion over 4 fixed cycles per prescribing information. | Drug | Aumolertinib + platinum-based doublet chemotherapy |
Primary outcome
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 5 years
PFS is defined as the time from date of randomization until date of disease progression or death due to any cause, whichever occurs first.
20 secondary outcomes
Overall Survival (OS)
Time frame: Up to 6 years
Objective Response Rate (ORR) as Assessed by BICR Per RECIST v1.1
Time frame: Up to 5 years
Disease Control Rate (DCR) as Assessed by BICR Per RECIST v1.1
Time frame: Up to 5 years
Tumor Growth Rate (TGR) as Assessed by BICR Per RECIST v1.1
Time frame: Up to 5 years
Duration of Response (DOR) as Assessed by BICR Per RECIST v1.1
Time frame: Up to 5 years
Depth of Response (DepOR) as Assessed by BICR Per RECIST v1.1
Time frame: Up to 5 years
PFS as Assessed by the Investigator Per RECIST v1.1
Time frame: Up to 5 years
ORR as Assessed by the Investigator Per RECIST v1.1
Time frame: Up to 5 years
DCR as Assessed by the Investigator Per RECIST v1.1
Time frame: Up to 5 years
TGR as Assessed by the Investigator Per RECIST v1.1
Time frame: Up to 5 years
DOR as Assessed by the Investigator Per RECIST v1.1
Time frame: Up to 5 years
DepOR as Assessed by the Investigator Per RECIST v1.1
Time frame: Up to 5 years
Quality of Life as Assessed by the National Cancer Institute Patient Reported Outcomes Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE) Questionnaire
Time frame: Up to 5 years
Rate of Circulating Tumor DNA (ctDNA) Clearance
Time frame: 6 weeks
Plasma Concentration of Aumolertinib
Time frame: Up to approximately 5 months
Plasma Concentration of Aumolertinib Metabolite
Time frame: Up to approximately 5 months
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: From date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), up to 5 years
Number of Participants With Serious Adverse Events (SAEs)
Time frame: From date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), up to 5 years
Number of Participants With Electrocardiogram (ECG) Abnormalities
Time frame: From date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), up to 5 years
Number of Participants With Laboratory Abnormalities
Time frame: From date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aumolertinib monotherapy, Osimertinib monotherapy and Pemetrexed in people with NSCLC, run by EQRx International, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.