Non Small Cell Lung CancerPhase 2NCT04636593

A Phase 2 Trial of Almonertinib With Concurrent Radiotherapy in The Treatment of Local Advanced EGFR-mutant NSCLC

A Phase 2 study testing Almonertinib in people with Non Small Cell Lung Cancer and Stage III NSCLC, run by First People's Hospital of Hangzhou 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Who is it for?: Ages 18 years and older
Conditions the study is for: Non Small Cell Lung Cancer, Stage III NSCLC, EGFR Activating Mutation
What is being tested?: Almonertinib
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteChina
Study dates: 1 Aug 2020to 31 Dec 2022
Phase: Phase 2
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

Confirmed histologically or pathologically as non-small cell lung cancer;
According to the eighth edition of the 2015 IASLC international lung cancer staging, imaging staging assessed as inoperable stage III patients (according to the eighth edition of the 2015 IASLC international lung cancer staging);
Blood or tissue EGFR detection is Exon 19 deletion or L858R mutation;
Have not received systemic anti-tumor therapy;
FEV1>0.75L;
Age ≥ 18 years old;

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ECOG PS score ≤ 2;
Estimated survival period ≥ 6 months;
Women must undergo surgical sterilization, post-menopausal, or take contraceptive measures during the treatment period and within 3 months after the end;
Sign the informed consent form.

Who cannot join

Previously received other anti-tumor treatment, including almonertinib or other EGFR-TKI drugs;
Contraindications for radiotherapy such as uncontrolled systemic lupus erythematosus, scleroderma or other connective tissue diseases;
Other malignant tumors within 5 years (except for non-melanoma skin cancer and cervical cancer);
Any medical or non-medical reasons prevent the patient from continuing to participate in the research;
It is expected that the patient will not be able to comply with the research procedures, restrictions and requirements, and researchers determine that the patient is not suitable for participating in the trial;
Currently receiving (or unable to stop using it before receiving the first dose of study treatment) drugs or herbal supplements known to be potent inducers of CYP3A4 (at least 3 weeks ago);

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The patient is taking any drugs that prolong the QT interval, and the drug cannot be stopped before the treatment of almonertinib;
Patients with lung V20 > 28% even after two-month almonertinib treatment.
Pregnancy or breastfeeding.

Trial locations and contacts

1 site in 1 country.

Shenglin Ma, M.D contact

086-0571-56006013

Mashenglin@medmail.com.cn

China1 site, 1 recruiting

Hangzhou Cancer hospital
Hangzhou, Zhejiang, 310002
Bing Xia, M.D, 086-0571-56006388, bxia_hzch@hotmail.com
Recruiting

Other trials in China

About this study

Official title: Almonertinib With Concurrent Radiotherapy in The Treatment of Unresectable, Stage Ⅲ Non-small-cell Lung Cancer Harboring EGFR Mutations: A PhaseⅡCohort Study

Previous clinical studies showed there is a potential value of EGFR-TKI in local advanced EGFR-mutant NSCLC, while the risk of radiation pneumonia in combination of EGFR-TKI with thoracic radiotherapy is unknown. This study aims to explore the safety and efficacy of concurrent almonertinib, a new third-generation EGFR-TKI drug, with radiotherapy in local advanced EGFR-mutant NSCLC patients.

Read the detailed description

Doublet platinum-based therapy combined with radiotherapy remains the standard treatment for first-line management of unresectable stage III NSCLC patients, regardless of the EGFR mutation status. But the 5-year survival rate is not satisfying. Previous clinical studies showed there is a potential value but also a high risk of radiation pneumonia in treatment regimens of combination TKI with radiotherapy. This study intends to explore the safety and efficacy of concurrent almonertinib, a new third-generation EGFR-TKI drug, with radiotherapy in EGFR-sensitive mutated locally advanced NSCLC patients.

Conditions: Non Small Cell Lung Cancer, Stage III NSCLC, EGFR Activating Mutation
Being tested: Almonertinib
Keywords: radiotherapy, radiation pneumonitis, almonertinib, lung cancer, EGFR-TKI
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Radiation Pneumonitis, Lung Neoplasms

What participants receive

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

AlmonertinibDrug
Also called Thoracic Radiotherapy
All enrolled patients underwent positioning CT scans before the initial treatment, a radiotherapy plan was made for each patient, and the lung V20 of each patient was calculated. Patients with lung V20 ≥ 28% were enrolled in group A: Almonertinib induction therapy was given for 2 months firstly, followed by Almonertinib combined with radiotherapy; patients with lung V20<28% were enrolled in group B: Almonertinib was synchronized with radiotherapy initially.

Study groups in NCT04636593
Study group	Role	What they receive
Induction group	Experimental	If the lung V20 of initial radiation plan is equal to or more than 28%, then the patient will receive 2 months almonertinib before concurrent thoracic radiotherapy Receives: Drug: Almonertinib
Concurrent group	Experimental	If the lung V20 of initial radiation plan is less than 28%, then the patient will receive concurrent thoracic radiotherapy with almonertinib. Receives: Drug: Almonertinib

What is being measured

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

RP(≥3)
incidence of radiation pneumonitis (≥ grade 3) within 6 month after Radiotherapy
Measured: 6 months

Secondary outcomes (3)

LCR
local control rate
Measured: 1 years
PFS
progression-free survival (PFS) defines as intervals from treatment to disease progression or death
Measured: 2 years
OS
overall survival (OS) intervals from treatment to death or last follow-uo
Measured: 2 years

Timeline

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

1 Aug 202031 Dec 2022

First posted19 Nov 2020
Study start1 Aug 2020
Primary completion31 Dec 2021 (estimated)
Study completion31 Dec 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Non Small Cell Lung CancerStudies 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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 43 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04636593
Sponsor's protocol ID: AlmonTRT
Status last verified: Jan 2021
First submitted: 15 Nov 2020
Last updated: 12 Jan 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Zhu L, Zou C, Zhang Z, Wang J, Yang L, Rao C, Yang Z, Liang J, Xia B, Shenglin MA. Thoracic radiotherapy and concurrent almonertinib for unresectable stage III EGFR-mutated non-small-cell lung cancer: a phase 2 study. BMC Cancer. 2021 May 7;21(1):511. doi: 10.1186/s12885-021-08266-w.
PubMed 33962566

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Almonertinib With Concurrent Radiotherapy in The Treatment of Unresectable, Stage Ⅲ Non-small-cell Lung Cancer Harboring EGFR Mutations: A PhaseⅡCohort Study
ClinicalTrials.gov ID: NCT04636593
Acronym / sponsor ID: AlmonTRT
Conditions: Non Small Cell Lung Cancer, Stage III NSCLC, EGFR Activating Mutation
Keywords: radiotherapy, radiation pneumonitis, almonertinib, lung cancer, EGFR-TKI
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 43 participants (estimated)
Lead sponsor: First People's Hospital of HangzhouUniversity, hospital or other
Collaborators: Hangzhou Cancer Hospital
Study start: 1 Aug 2020 (actual)
Primary completion: 31 Dec 2021 (estimated)
Study completion: 31 Dec 2022 (estimated)
First posted: 19 Nov 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Induction group	Experimental	Drug: AlmonertinibIf the lung V20 of initial radiation plan is equal to or more than 28%, then the patient will receive 2 months almonertinib before concurrent thoracic radiotherapy
Concurrent group	Experimental	Drug: AlmonertinibIf the lung V20 of initial radiation plan is less than 28%, then the patient will receive concurrent thoracic radiotherapy with almonertinib.

Who may qualify

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

Key inclusion criteria (10 listed)

Confirmed histologically or pathologically as non-small cell lung cancer;
According to the eighth edition of the 2015 IASLC international lung cancer staging, imaging staging assessed as inoperable stage III patients (according to the eighth edition of the 2015 IASLC international lung cancer staging);
Blood or tissue EGFR detection is Exon 19 deletion or L858R mutation;
Have not received systemic anti-tumor therapy;
FEV1>0.75L;

Key exclusion criteria (9 listed)

Previously received other anti-tumor treatment, including almonertinib or other EGFR-TKI drugs;
Contraindications for radiotherapy such as uncontrolled systemic lupus erythematosus, scleroderma or other connective tissue diseases;
Other malignant tumors within 5 years (except for non-melanoma skin cancer and cervical cancer);
Any medical or non-medical reasons prevent the patient from continuing to participate in the research;
It is expected that the patient will not be able to comply with the research procedures, restrictions and requirements, and researchers determine that the patient is not suitable for participating in the trial;

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: Thoracic RadiotherapyAll enrolled patients underwent positioning CT scans before the initial treatment, a radiotherapy plan was made for each patient, and the lung V20 of each patient was calculated. Patients with lung V20 ≥ 28% were enrolled in group A: Almonertinib induction therapy was given for 2 months firstly, followed by Almonertinib combined with radiotherapy; patients with lung V20<28% were enrolled in group B: Almonertinib was synchronized with radiotherapy initially.	Drug	Concurrent group, Induction group

Primary outcome

RP(≥3)
Time frame: 6 months
incidence of radiation pneumonitis (≥ grade 3) within 6 month after Radiotherapy

3 secondary outcomes

LCR
Time frame: 1 years
PFS
Time frame: 2 years
OS
Time frame: 2 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
Derived from this study: PubMed 33962566Zhu L, Zou C, Zhang Z, Wang J, Yang L, Rao C, Yang Z, Liang J, Xia B, Shenglin MA. Thoracic radiotherapy and concurrent almonertinib for unresectable stage III EGFR-mutated non-small-cell lung cancer: a phase 2 study. BMC Cancer. 2021 May 7;21(1):511. doi: 10.1186/s12885-021-08266-w.
Individual participant dataSharing planned: No

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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.

Shenglin Ma, M.D contact

086-0571-56006013

Mashenglin@medmail.com.cn

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 Almonertinib in people with Non Small Cell Lung Cancer and Stage III NSCLC, run by First People's Hospital of Hangzhou 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 9 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 12 Jan 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 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?

Results are not available in the source record.

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

Contact Shenglin Ma, M.D (086-0571-56006013, Mashenglin@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RP(≥3) (time frame: 6 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 NCT04636593, which also lists 1 linked publication.

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 12 Jan 2021.