Malignant Tumor of LungPhase 1NCT05826483
Almonertinib in the First-line Treatment of Patients of NSCLC With Poor Performance Status
A Phase 1 study testing Almonertinib in people with Malignant Tumor of Lung and Poor Performance Status, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
Most of the lung cancer patients treated in hospitals in China are in advanced stage, accounting for more than 2/3 of all lung cancer patients, and some of the patients have a poor performence status.At present, most of the patients included in clinical trials are patients with good PS score, and the NCCN guidelines… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Tumor of Lung, Poor Performance Status
- What is being tested?
- Almonertinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Dec 2024
- Phase
- Phase 1
- 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
- The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
- Male or female who is over 18 years old.
- Malignant tumorsr proved by pathology.
- NSCLC patients with EGFR mutation (19 deletion/21 L858R point mutation) or primary T790M mutation in pre-enrollment genetic testing.
- PS score of 2-4; this score is caused by complications caused by the tumor and cannot be improved by any non-anti-tumor means.
- Patients with brain metastases may be enrolled at the discretion of the investigator.
- Appropriate organ system function.
Who cannot join
- Patients who have previously used any antineoplastic drugs。
- Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer);
- Genetic testing results in patients with rare EGFR genotypes (G719X, E709X, Del18 on exon 18, Ins19 on exon 19, Ins20, S768I on exon 20, and L861Q on exon 21).
- Patients with other mutations (ALK, Ros-1, C-MET).
- Imperfection of upper gastrointestinal physiology, or absorption disorder syndrome, or inability to tolerate oral drugs, or active peptic ulcer;
- Participated in other clinical trials within 4 weeks before the start of the study;
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- patients with hypertension who cannot control well through single antihypertensive medication (systolic blood pressure > 140mmhg, diastolic blood pressure > 90mmhg), myocardial ischemia or myocardial infarction, arrhythmia (including QT interval > 440 ms) or cardiac insufficiency;
- Allergic to any ingredient in the drug;
- Patients with abnormal coagulation function, receiving thrombolysis or anticoagulation therapy, bleeding tendency or have clear gastrointestinal bleeding concerns;
- Hyperactive/venous thrombosis events, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism occurred in 6 months before the start of the study;
- Wound or fracture has not been healed for a long time;
- urinary protein was greater than ++ and 24-hour urinary protein quantification #1.0 g.
- Severe or uncontrolled infections;
- Substance abuse or mental disorder;
- Objective evidence of a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, and severe impairment of pulmonary function;
- Immunodeficiency, including being HIV-positive, or having other acquired, congenital immunodeficiency diseases, or having a history of organ transplantation;
- Other malignant tumors within 5 years, except cured basal cell carcinoma of the skin and orthotopic carcinoma of the cervix;
- Who have received VEGFR inhibitors, such as sorafenib and sunitinib, etc.;
- pregnant or lactating women;
- the researchers considered it unsuitable for inclusion。
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhou Chengzhi
Guangzhou, Guangdong, 510120
Chengzhi Zhou, Professor, 13560351186, doctorzcz@163.com
About this study
Official title: Exploration of the Clinical Application of Almonertinib in the First-line Treatment of Patients With EGFR Mutation-positive Advanced Non-small Cell Lung Cancer With Poor Performance Status
Most of the lung cancer patients treated in hospitals in China are in advanced stage, accounting for more than 2/3 of all lung cancer patients, and some of the patients have a poor performence status.At present, most of the patients included in clinical trials are patients with good PS score, and the NCCN guidelines for advanced lung cancer patients with poor performence status recommend the best supportive care.Therefore, the investigator wanted to explore the efficacy and safety of Almonertinib in lung cancer patients with poor performance status.
Read the detailed description
Most of the lung cancer patients treated in hospitals in China are in advanced stage, accounting for more than 2/3 of all lung cancer patients, and some of the patients have a poor performence status.In recent years, systemic treatments with good efficacy and low toxicity, such as gene-targeted therapy, anti-angiogenic therapy and immunotherapy, have largely replaced single chemotherapy, and have great potential to benefit from existing treatments for poor PS scores of advanced lung cancer patients can adopt more aggressive treatment strategies.At present, most of the patients included in clinical trials are patients with good PS score, and the NCCN guidelines for advanced lung cancer patients with poor performence status recommend the best supportive care.Therefore,the investigator wanted to explore the efficacy and safety of Almonertinib in lung cancer patients with poor performance status.
- Conditions
- Malignant Tumor of Lung, Poor Performance Status
- Being tested
- Almonertinib
- Keywords
- Almonertinib, Non-Small Cells Lung Cancer, poor performance status
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlmonertinibDrug
Almonertinib Mesilate Tablets
| Study group | Role | What they receive |
|---|---|---|
| Almonertinib | Experimental | Almonertinib, 110 mg, po, QD; 28 days every cycle Receives: Drug: Almonertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate
Measured: 24 months
Time of PS score change from 2~4 to 1
Time of performance status score change from 2~4 to 1
Measured: 6 months
Secondary outcomes (3)
PFS
Median progression-free survival
Measured: 24 months
OS
Median overall survival
Measured: from baseline until death due to any cause, up to a maximum of approximately 4years
DCR
Disease control rate
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 Jan 2022
- Primary completion28 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Tumor of LungStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment Almonertinib monotherapy
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Chengzhi, Guangzhou Institute of Respiratory Disease
- Investigators
- Zhou Chengzhi, MD, Study director, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826483
- Sponsor's protocol ID
- CROC202201
- Status last verified
- Apr 2023
- First submitted
- 5 Feb 2022
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Clinical Application of Almonertinib in the First-line Treatment of Patients With EGFR Mutation-positive Advanced Non-small Cell Lung Cancer With Poor Performance Status
- ClinicalTrials.gov ID
- NCT05826483
- Acronym / sponsor ID
- CROC202201
- Conditions
- Malignant Tumor of Lung, Poor Performance Status
- Keywords
- Almonertinib, Non-Small Cells Lung Cancer, poor performance status
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 28 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 24 Apr 2023 (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.
Most of the lung cancer patients treated in hospitals in China are in advanced stage, accounting for more than 2/3 of all lung cancer patients, and some of the patients have a poor performence status.At present, most of the patients included in clinical trials are patients with good PS score, and the NCCN guidelines for advanced lung cancer patients with poor performence status recommend the best supportive care.Therefore, the investigator wanted to explore the efficacy and safety of Almonertinib in lung cancer patients with poor performance status.
Detailed description
Most of the lung cancer patients treated in hospitals in China are in advanced stage, accounting for more than 2/3 of all lung cancer patients, and some of the patients have a poor performence status.In recent years, systemic treatments with good efficacy and low toxicity, such as gene-targeted therapy, anti-angiogenic therapy and immunotherapy, have largely replaced single chemotherapy, and have great potential to benefit from existing treatments for poor PS scores of advanced lung cancer patients can adopt more aggressive treatment strategies.At present, most of the patients included in clinical trials are patients with good PS score, and the NCCN guidelines for advanced lung cancer patients with poor performence status recommend the best supportive care.Therefore,the investigator wanted to explore the efficacy and safety of Almonertinib in lung cancer patients with poor performance status.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment Almonertinib monotherapy
| Arm | Type | Receives |
|---|---|---|
| Almonertinib | Experimental | Drug: AlmonertinibAlmonertinib, 110 mg, po, QD; 28 days every cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
- Male or female who is over 18 years old.
- Malignant tumorsr proved by pathology.
- NSCLC patients with EGFR mutation (19 deletion/21 L858R point mutation) or primary T790M mutation in pre-enrollment genetic testing.
- PS score of 2-4; this score is caused by complications caused by the tumor and cannot be improved by any non-anti-tumor means.
Key exclusion criteria (20 listed)
- Patients who have previously used any antineoplastic drugs。
- Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer);
- Genetic testing results in patients with rare EGFR genotypes (G719X, E709X, Del18 on exon 18, Ins19 on exon 19, Ins20, S768I on exon 20, and L861Q on exon 21).
- Patients with other mutations (ALK, Ros-1, C-MET).
- Imperfection of upper gastrointestinal physiology, or absorption disorder syndrome, or inability to tolerate oral drugs, or active peptic ulcer;
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 |
|---|---|---|
| AlmonertinibAlmonertinib Mesilate Tablets | Drug | Almonertinib |
Primary outcome
ORR
Time frame: 24 months
Objective Response Rate
Time of PS score change from 2~4 to 1
Time frame: 6 months
Time of performance status score change from 2~4 to 1
3 secondary outcomes
PFS
Time frame: 24 months
OS
Time frame: from baseline until death due to any cause, up to a maximum of approximately 4years
DCR
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Individual participant dataSharing planned: No. no plan
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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.
Zhou Chengzhi, MD study director
The First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Almonertinib in people with Malignant Tumor of Lung and Poor Performance Status, run by Guangzhou Institute of Respiratory Disease 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 7 inclusion and 20 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 24 Apr 2023. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Zhou Chengzhi, MD (13560351186, doctorzcz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 24 months). The study lists 2 primary outcomes in all. 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 24 Apr 2023.