Non-small Cell Lung CancerPhase 3NCT04951648

A Phase III Study to Assess the Efficacy and Safety of Almonertinib Versus Platinum-based Chemotherapy as First-line Therapy in Patients With Locally Advanced or Metastatic NSCLC Harbouring Uncommon EGFR Mutation

A Phase 3 study testing Almonertinib and chemotherapy in people with Non-small Cell Lung Cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

To assess the efficacy and safety of Almonertinib versus platinum-based chemotherapy as first-line therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring uncommon EGFR mutation. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-small Cell Lung Cancer
What is being tested?: Almonertinib and chemotherapy
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 220 participants
Where: 1 siteChina
Study dates: 15 Jul 2021to 6 Sep 2024
Phase: Phase 3
Are there results?: None posted in the registry

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

Subjects are willing to participate in this clinical study, understand the study procedures and are able to sign the informed consent in person.
Age at least 18 years.
Histologically or cytologically confirmed diagnosis of primary non-small lung cancer (NSCLC), histologically confirmed non-squamous pathology.
Locally advanced or metastatic NSCLC.
Patients must be treatment-naïve for locally advanced or metastatic NSCLC.
The tumor harbors uncommon EGFR mutations (one of the following EGFR mutation: L861Q, G719X or S768I), assessed by Xiamen AmoyDx EGFR (ADx-ARMS, Super-ARMS method) kit in central laboratory.

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Measurable disease by RECIST 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Female patients should be using adequate contraceptive measures and should not be breastfeeding during the study and six months after the last dosing of study. Male patients should be willing to use barrier contraception (condoms) during the study and six months after the last dosing of study.
A pregnancy test should be done before randomization unless having an evidence of non-child-bearing potential.

Who cannot join

Treatment with any of the following:
Prior treatment with EGFR-TKI therapy.
Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks prior to randomization.
The presence of pleural effusion/peritoneal effusion/pericardial effusion requiring clinical intervention.
Major surgery within 4 weeks prior to randomization.
Spinal cord compression or unstable brain metastasis; Meningeal or brainstem metastases.

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Patients had received medications or herbal supplements known to be strong inducers and inhibitors of cytochrome CYP3A4 within 7 days prior to randomization or required to continue these agents during the study period.
Patients are receiving medications known to prolong QT interval or may cause tip torsion ventricular tachycardia, or are still in the washout period (relatively random phase), or need to be continued during the study period.
Patients were subjects in another clinical trial within 4 weeks prior to randomization or patients were within 5 half-lives of any other investigational agent.
Any unresolved toxicity Common Terminology Criteria for Adverse Events (CTCAE) ≥ Grade 2 from the prior anticancer therapy.
Inadequate bone marrow reserve or organ function.
Any of the following cardiac criteria:
Mean resting corrected QT interval (QTc) > 470 ms obtained from 3 electrocardiograms (ECGs), using the screening clinic's ECG machine and Fridericia's formula for QT interval correction (QTcF).
Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG (e.g., PR interval > 250 ms).
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure or any concomitant medication known to prolong the QT interval.
Left ventricular ejection fraction (LVEF) <50%.
History of other malignancies, excluding fully treated non-melanoma skin cancer, Malignant freckled nevus, in-situ cancer, other solid tumors that hadn't been recurrent for > 5 years following the end of treatment, or local prostate cancer after radical resection.
Any evidence of severe or uncontrolled systemic diseases (including uncontrolled hypertension and active bleeding diatheses) or active infection (including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV), etc.).
Acquired or congenital immune deficiency diseases, or history of organ transplantation.
Serious gastrointestinal function abnormalities that may interfere with drug ingestion, transport, or absorption.
Any severe and uncontrolled ocular disease that may, in the ophthalmologist's opinion, present a specific risk to the patient's safety.
Pregnant or lactating, or intending to become pregnant during the study
Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
Any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments.

Trial locations and contacts

1 site in 1 country.

Li Zhang contact

020-87342288

zhangli@sysucc.org.cn

China1 site

Sun yat-sen Univerisity Cancer Center
Guangzhou, Guangdong
Li Zhang, 020-87342288, zhangli@sysucc.org.cn

Other trials in China

About this study

Official title: A Randomized Controlled, Open-lable, Phase III, Multicenter Clinical Study of Almonertinib Versus Platinum-based Chemotherapy as First-line Therapy in Patients With Locally Advanced or Metastatic NSCLC Harbouring Uncommon EGFR Mutation

Read the detailed description

This is a randomized, open-lable, multicenter, phase III study to assess the efficacy and safety of Almonertinib versus platinum-based chemotherapy as first-line therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring at least one uncommon EGFR mutation, including L861Q, G719X or S768I. Patients who have not received any systemic treatment to receive Almonertinib or platinum-based chemotherapy in a 1:1 ratio, and treatment will be continued until disease progression, unacceptable toxicity or other discontinuation criteria are met. After progression, patients may receive Almonertinib for as long as their treating physician considers they are deriving clinical benefit.

Conditions: Non-small Cell Lung Cancer
Being tested: Almonertinib, chemotherapy
Keywords: Phase III, NSCLC, Almonertinib, uncommon EGFR mutation, first-line therapy，platinum-based chemotherapy
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AlmonertinibDrug
Also called HS-10296
Almonertinib 165 mg，orally once a day Treatment can continue until disease progression, unacceptable toxicity or other discontinuation criteria are met.
chemotherapyDrug
Pemetrexed (500mg/m2) plus Carboplatin (AUC5)or Pemetrexed (500mg/m2) plus Cisplatin (75mg/m2) on Day 1 of 21day cycles (every 3 weeks) for 4~6 cycles, followed by pemetrexed mainten-ance therapy every 3 weeks until disease progress-ssion, unacceptable toxicity or other discontinuation criteria are met.

Study groups in NCT04951648
Study group	Role	What they receive
Almonertinib	Experimental	Not described Receives: Drug: Almonertinib
Platinum-based doublet chemotherapy	Active comparator	Not described Receives: Drug: chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-free survival (PFS) assessed by IRC (Independent Review Committee)
PFS is defined as the time from randomization until the date of objective disease progression or death regardless of whether the patient withdraws from randomised therapy or receives another anti-cancer therapy prior to progression, based on blinded independent central review assessment according to RECIST 1.1.
Measured: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression; up to a maximum of approximately 2 years.

Secondary outcomes (12)

PFS assessed by INVs (Investigators)
PFS is defined as the time from randomization until the date of disease progression as assessed by INVs according to RECIST 1.1 or death from any cause on study.
Measured: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression; up to a maximum of approximately 2 years.
Objective response rate (ORR) assessed by IRC
ORR is defined as the number (%) of patients with at least 1 visit response of CR (Complete response) or PR (Partial response) based on blinded independent central review assessment according to RECIST 1.1.
Measured: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression; up to a maximum of approximately 2 years.
Duration of response (DoR) assessed by IRC
DoR is defined as the time from date for first documented response of until the documented response of progression per RECIST 1.1 or death in the absence of progression based on blinded independent central review assessment.
Measured: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression; up to a maximum of approximately 2 years.
Disease control rate (DCR) assessed by IRC
DCR is defined as the percentage of patients who have a best overall response of CR or PR or SD based on blinded independent central review assessment according to RECIST 1.1.
Measured: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression; up to a maximum of approximately 2 years.
Depth of response (DepOR) assessed by IRC
DepOR is defined as the change amount of the sum of the lengths of the longest diameters of the target lesions on blinded independent central review assessment according to RECIST 1.1 in the absence of New Lesions (NLs) or progression of Non-Target Lesions when compared to baseline.
Measured: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression; up to a maximum of approximately 3 years.
Proportion of patients alive and progression free at 6 months (APF6) assessed by IRC
APF6 is defined as the percentage (%) of patients who were alive and progression free per RECIST 1.1 at 6 months after randomization.
Measured: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 6 months post-randomization.
Proportion of patients alive and progression free at 9 months (APF9) assessed by IRC
APF9 is defined as the percentage (%) of patients who were alive and progression free per RECIST 1.1 at 9 months after randomization.
Measured: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 9 months post-randomization.
Proportion of patients alive and progression free at 12 months (APF12) assessed by IRC
APF12 is defined as the percentage (%) of patients who were alive and progression free per RECIST 1.1 at 12 months after randomization.
Measured: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 12 months post-randomization.
Proportion of patients alive and progression free at 24 months (APF24) assessed by IRC
APF24 is defined as the percentage (%) of patients who were alive and progression free per RECIST 1.1 at 24 months after randomization.
Measured: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 24 months post-randomization.
Overall survival (OS)
OS is deﬁned as the time from the date of randomization until death due to any cause.
Measured: From the date of randomization until death due to any cause; up to a maximum of approximately 3 years.
Percentage of patients alive at 36 months (OS36)
OS36 was defined as the percentage (%) of patients who were alive at 36 months after randomization per the Kaplan-Meier estimate of OS at 36 months.
Measured: From randomization until death due to any cause, up to a maximum of approximately 3 years.
Incidence of Adverse Events (AEs)
AEs are graded according to CTCAE v5.0 and recorded in the case report form.
Measured: From the screening period to 28 days after treatment completion, approximately 3 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 20216 Sep 2024

First posted7 Jul 2021
Study start15 Jul 2021 (estimated)
Primary completion4 Oct 2023 (estimated)
Study completion6 Sep 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
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: 220 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04951648
Sponsor's protocol ID: HS-10296-305
Status last verified: Jun 2021
First submitted: 30 Jun 2021
Last updated: 7 Jul 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled, Open-lable, Phase III, Multicenter Clinical Study of Almonertinib Versus Platinum-based Chemotherapy as First-line Therapy in Patients With Locally Advanced or Metastatic NSCLC Harbouring Uncommon EGFR Mutation
ClinicalTrials.gov ID: NCT04951648
Acronym / sponsor ID: HS-10296-305
Conditions: Non-small Cell Lung Cancer
Keywords: Phase III, NSCLC, Almonertinib, uncommon EGFR mutation, first-line therapy，platinum-based chemotherapy
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 220 participants (estimated)
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 15 Jul 2021 (estimated)
Primary completion: 4 Oct 2023 (estimated)
Study completion: 6 Sep 2024 (estimated)
First posted: 7 Jul 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Almonertinib	Experimental	Drug: Almonertinib
Platinum-based doublet chemotherapy	Active comparator	Drug: chemotherapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Subjects are willing to participate in this clinical study, understand the study procedures and are able to sign the informed consent in person.
Age at least 18 years.
Histologically or cytologically confirmed diagnosis of primary non-small lung cancer (NSCLC), histologically confirmed non-squamous pathology.
Locally advanced or metastatic NSCLC.
Patients must be treatment-naïve for locally advanced or metastatic NSCLC.

Key exclusion criteria (24 listed)

Treatment with any of the following:
Any unresolved toxicity Common Terminology Criteria for Adverse Events (CTCAE) ≥ Grade 2 from the prior anticancer therapy.
Inadequate bone marrow reserve or organ function.
Any of the following cardiac criteria:
History of other malignancies, excluding fully treated non-melanoma skin cancer, Malignant freckled nevus, in-situ cancer, other solid tumors that hadn't been recurrent for > 5 years following the end of treatment, or local prostate cancer after radical resection.

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
AlmonertinibAlso: HS-10296Almonertinib 165 mg，orally once a day Treatment can continue until disease progression, unacceptable toxicity or other discontinuation criteria are met.	Drug	Almonertinib
chemotherapyPemetrexed (500mg/m2) plus Carboplatin (AUC5)or Pemetrexed (500mg/m2) plus Cisplatin (75mg/m2) on Day 1 of 21day cycles (every 3 weeks) for 4~6 cycles, followed by pemetrexed mainten-ance therapy every 3 weeks until disease progress-ssion, unacceptable toxicity or other discontinuation criteria are met.	Drug	Platinum-based doublet chemotherapy

Primary outcome

Progression-free survival (PFS) assessed by IRC (Independent Review Committee)
Time frame: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression; up to a maximum of approximately 2 years.
PFS is defined as the time from randomization until the date of objective disease progression or death regardless of whether the patient withdraws from randomised therapy or receives another anti-cancer therapy prior to progression, based on blinded independent central review assessment according to RECIST 1.1.

12 secondary outcomes

PFS assessed by INVs (Investigators)
Time frame: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression; up to a maximum of approximately 2 years.
Objective response rate (ORR) assessed by IRC
Time frame: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression; up to a maximum of approximately 2 years.
Duration of response (DoR) assessed by IRC
Time frame: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression; up to a maximum of approximately 2 years.
Disease control rate (DCR) assessed by IRC
Time frame: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression; up to a maximum of approximately 2 years.
Depth of response (DepOR) assessed by IRC
Time frame: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression; up to a maximum of approximately 3 years.
Proportion of patients alive and progression free at 6 months (APF6) assessed by IRC
Time frame: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 6 months post-randomization.
Proportion of patients alive and progression free at 9 months (APF9) assessed by IRC
Time frame: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 9 months post-randomization.
Proportion of patients alive and progression free at 12 months (APF12) assessed by IRC
Time frame: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 12 months post-randomization.
Proportion of patients alive and progression free at 24 months (APF24) assessed by IRC
Time frame: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 24 months post-randomization.
Overall survival (OS)
Time frame: From the date of randomization until death due to any cause; up to a maximum of approximately 3 years.
Percentage of patients alive at 36 months (OS36)
Time frame: From randomization until death due to any cause, up to a maximum of approximately 3 years.
Incidence of Adverse Events (AEs)
Time frame: From the screening period to 28 days after treatment completion, approximately 3 years.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
Individual participant dataSharing planned: Undecided

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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.

Li Zhang contact

020-87342288

zhangli@sysucc.org.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Almonertinib and chemotherapy in people with Non-small Cell Lung Cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.

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 10 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Li Zhang (020-87342288, zhangli@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) assessed by IRC (Independent Review Committee) (time frame: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression; up to a maximum of approximately 2 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04951648.

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 7 Jul 2021.