Non-small Cell Lung Cancer Stage IIIPhase 2NCT04685070

Neoadjuvant HS-10296 (Almonertinib) Therapy for Potential Resectable Stage III EGFR Mutation-Positive Non-small Cell Lung Cancer

A Phase 2 study testing HS-10296 (Almonertinib) in people with Non-small Cell Lung Cancer Stage III, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This is a phase II, single-arm, open-label study to evaluate the efficacy and safety of the third generation tyrosine kinase inhibitors (TKIs) Almonertinib (HS-10296) as neoadjuvant and adjuvant therapy for potential resectable stage III EGFR mutation-positive Non-small Cell Lung Cancer. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Non-small Cell Lung Cancer Stage III
What is being tested?: HS-10296 (Almonertinib)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 1 siteChina
Study dates: 14 Dec 2021to 31 Dec 2027
Phase: Phase 2
Are there results?: Not yet: the study is under way

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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

NSCLC patient with EGFR sensitive mutation as confirmed by needle biopsy;
At stage III (TNM Staging, Version 8) as identified by chest CT, PET-CT or/and EBUS;
No systemic metastasis (confirmed by head MRI, whole body bone scan, PET-CT, liver and adrenal CT, etc.);
With the feasibility to receive radical surgery ;
Good lung function that could tolerate surgical treatment;
Aged 18-75 years;

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At least one measurable tumor foci (the longest diameter measured by CT shall be > 10 mm);
Other major organs shall function well (liver, kidney, blood system, etc.):
ECOG PS score shall be 0-1;
The child-bearing female must undergo pregnancy test within 7 days before starting the treatment and the result shall be negative. Reliable contraceptive measures, such as intrauterine device, contraceptive pill and condom, shall be adopted during the trial and within 30 days after completion of the trial. The child-bearing male shall use condom for contraception during the trial and within 30 days after completion of the trial;
The patient shall sign the Informed Consent Form.

Who cannot join

The patient has undergone any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment, etc.;
The patient suffered from other cancers besides NSCLC (except cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumor [including Ta and Tis]) within 5 years before the trial;
The patient suffers from any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that starts to attack within the last 3 months, congestive heart failure [≥ Grade II specified by New York Heart Association (NYHA)], cardiac infarction (6 months before enrollment), severe arrhythmia and liver, kidney or metabolic diseases that requires drug treatment;
The patient is a carrier of active hepatitis B, hepatitis C or HIV;
The patient suffers from severe or new-onset gastrointestinal diseases with diarrhea as the main symptom;
The patient has had or is currently suffering from cardiovascular malformation;

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The patient has had or is currently suffering from interstitial lung disease;
The patient had undergone other major systemic operations or suffered from severe trauma within 3 months before the trial;
The patient is allergic to afatinib or its any excipients;
The patient suffers from nervous system diseases or mental diseases and cannot keep compliance with the trial;
The patient has any malabsorption condition;
The female patient is in pregnancy or lactation period;
There are any conditions under which the investigator considers the patient is not suitable to be enrolled.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433

Other trials in China

About this study

Official title: Neoadjuvant HS-10296 (Almonertinib) Therapy for Potential Resectable Stage III EGFR Mutation-Positive Non-small Cell Lung Cancer: A Single-Arm, Open-Label, Phase II Clinical Trial

Conditions: Non-small Cell Lung Cancer Stage III
Being tested: HS-10296 (Almonertinib)
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.

HS-10296 (Almonertinib)Drug
Neoadjuvant treatment stage: HS-10296 110mg, qd, po, 4 weeks per cycle, 2-4 cycles in total; Surgical treatment stage: CR + PR patients and SD + PD patients who could still undergo surgery will receive radical surgery; Adjuvant treatment stage: CR, PR and SD patients who have been treated surgically: HS-10296 110mg, qd, po, up to 48 weeks (including neoadjuvant stage). PD patients: transferred into medical oncology or/and radiation oncology and receive comprehensive therapy.

Study groups in NCT04685070
Study group	Role	What they receive
HS-10296 (Almonertinib)	Experimental	Not described Receives: Drug: HS-10296 (Almonertinib)

What is being measured

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

Objective response rate (ORR)
ORR is defined as the proportion of patients who have completed the neoadjuvant treatment before operation and have achieved CR or PR as confirmed by CT evaluation in all patients.
Measured: up to 4 months

Secondary outcomes (6)

Major pathologic response (MPR)
MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery.
Measured: up to 5 months
Event free survival (EFS)
It refers to the time from randomization to disease progression, cessation of treatment for any reason, or death
Measured: up to 60 months
Overall survival (OS)
It is defined as the time from random enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date.
Measured: up to 60 months
R0 resection rate
complete removal of the tumor, with a negative microscopic margin indicating no residual tumor
Measured: up to 6 months
Treatment-related adverse events
It refers to the number of adverse events related to HS-10296 as evaluated according to CTCAE v4.0.
Measured: up to 13 months
Pathological complete response rate (pCR)
It refers to the number of cases with no residual invasive cancer in the primary tumor and lymph node HE staining accounted for the proportion of all patients who completed the treatment.
Measured: up to 24 months

Timeline

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

14 Dec 202131 Dec 2027

First posted28 Dec 2020
Study start14 Dec 2021
Primary completion31 Dec 2022
Study completion31 Dec 2027 (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 Cancer Stage IIIStudies of the same condition, open and under way.
More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 56 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04685070
Sponsor's protocol ID: LungMate-007
Status last verified: Aug 2024
First submitted: 5 Dec 2020
Last updated: 14 Aug 2024
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 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neoadjuvant HS-10296 (Almonertinib) Therapy for Potential Resectable Stage III EGFR Mutation-Positive Non-small Cell Lung Cancer: A Single-Arm, Open-Label, Phase II Clinical Trial
ClinicalTrials.gov ID: NCT04685070
Acronym / sponsor ID: LungMate-007
Conditions: Non-small Cell Lung Cancer Stage III
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 56 participants (estimated)
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
Study start: 14 Dec 2021 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 31 Dec 2027 (estimated)
First posted: 28 Dec 2020 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
HS-10296 (Almonertinib)	Experimental	Drug: HS-10296 (Almonertinib)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

NSCLC patient with EGFR sensitive mutation as confirmed by needle biopsy;
At stage III (TNM Staging, Version 8) as identified by chest CT, PET-CT or/and EBUS;
No systemic metastasis (confirmed by head MRI, whole body bone scan, PET-CT, liver and adrenal CT, etc.);
With the feasibility to receive radical surgery ;
Good lung function that could tolerate surgical treatment;

Key exclusion criteria (13 listed)

The patient has undergone any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment, etc.;
The patient suffered from other cancers besides NSCLC (except cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumor [including Ta and Tis]) within 5 years before the trial;
The patient suffers from any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that starts to attack within the last 3 months, congestive heart failure [≥ Grade II specified by New York Heart Association (NYHA)], cardiac infarction (6 months before enrollment), severe arrhythmia and liver, kidney or metabolic diseases that requires drug treatment;
The patient is a carrier of active hepatitis B, hepatitis C or HIV;
The patient suffers from severe or new-onset gastrointestinal diseases with diarrhea as the main symptom;

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
HS-10296 (Almonertinib)Neoadjuvant treatment stage: HS-10296 110mg, qd, po, 4 weeks per cycle, 2-4 cycles in total; Surgical treatment stage: CR + PR patients and SD + PD patients who could still undergo surgery will receive radical surgery; Adjuvant treatment stage: CR, PR and SD patients who have been treated surgically: HS-10296 110mg, qd, po, up to 48 weeks (including neoadjuvant stage). PD patients: transferred into medical oncology or/and radiation oncology and receive comprehensive therapy.	Drug	HS-10296 (Almonertinib)

Primary outcome

Objective response rate (ORR)
Time frame: up to 4 months
ORR is defined as the proportion of patients who have completed the neoadjuvant treatment before operation and have achieved CR or PR as confirmed by CT evaluation in all patients.

6 secondary outcomes

Major pathologic response (MPR)
Time frame: up to 5 months
Event free survival (EFS)
Time frame: up to 60 months
Overall survival (OS)
Time frame: up to 60 months
R0 resection rate
Time frame: up to 6 months
Treatment-related adverse events
Time frame: up to 13 months
Pathological complete response rate (pCR)
Time frame: up to 24 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HS-10296 (Almonertinib) in people with Non-small Cell Lung Cancer Stage III, run by Shanghai Pulmonary Hospital, Shanghai, China 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 11 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Objective response rate (ORR) (time frame: up to 4 months). 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 NCT04685070.

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 14 Aug 2024.