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Lung Cancer Stage IVPhase 2NCT04519983

Efficacy of SRT as Salvage Therapy in Patients With Brain Oligo-progression of EGFR-mutant Non-small Cell Lung Cancer After Failure of the Third-generation EGFR-TKIs

A Phase 2 study testing Aumolertinib Oral Tablet in people with Lung Cancer Stage IV, run by Shanghai Cancer Hospital, China 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 The sponsor has not verified this record for over two years, so it may be out of date.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

About 20%-40% of NSCLC patients develop intracranial metastases, and most clinical studies suggest that the survival of lung cancer patients will be significantly shortened once they develop intracranial metastases. Read more about this study

Who is it for?
Ages 15 to 75 years
Conditions the study is for
Lung Cancer Stage IV
What is being tested?
Aumolertinib Oral Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
1 Jan 2022to 15 Dec 2023
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 15 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age ≥ 18 and ≤ 75.
  • Life expectancy exceeding 3 months.
  • Histologic or cytologic pathology confirmed non-small cell lung cancer. However, sputum cytology results alone are not acceptable. The cytology results of tracheal swabbing, tracheal irrigation fluid and needle aspiration are acceptable.
  • Investigators have confirmed the presence of at least one intracranial measurable lesion according to RECIST 1.1 criteria.
  • Patients with stage IV NSCLC with intracranial metastases at MR baseline.
  • Eastern Oncology Collaborative Group (ECOG) fitness status score of 0 or 1.
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  • Genetic testing suggests EGFR driver gene positivity, which can be accompanied by other driver gene positivity.
  • Oligo-progression of intracranial tumors at the most recent evaluation following treatment with third- generation TKIs.
  • Good hematopoiesis, defined as an absolute neutrophil count ≥1.5 × 109/L, platelet count ≥100 ×109/L, blood erythropoietin ≥ 90 g/L [7 days without transfusion or erythropoietin (EPO-dependent).
  • Good liver function, defined as total bilirubin levels ≤ 1.5 times the upper limit of normal (ULN); inpatients without hepatic metastases, glutinous rice straw is used as a supplement.
  • Aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN; for patients with documented liver metastases. AST and ALT levels ≤5 times ULN.
  • Good renal function, defined as serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance ≥60 ml/min
  • (Cockcroft-Gault formula); less than 2+ urine protein on routine urinalysis, or 24-hour urine protein quantification <1 g.
  • Good coagulation, defined as an International Standardized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5times ULN; if the subject is receiving anticoagulant therapy, provided that the PT is within the intended range of use of the anticoagulant.
  • For female subjects of childbearing age, within 3 days prior to receiving the first study drug administration (Week 1, Day 1) A negative urine or serum pregnancy test is performed. If a negative urine pregnancy test cannot be confirmed, a blood pregnancy test may be ordered test.
  • High-performance contraception (i.e., methods with a failure rate of less than 1 per cent per year) for both male and female patients if there is a risk of conception.

Who cannot join

  • NSCLC EGFR driver gene negativity.
  • Patients who cannot be examined by MR.
  • Pathological examination of a mixture of small cell lung cancer components.
  • Currently participating in an interventional clinical research treatment or have received another investigational drug within 4 weeks prior to the first administration of the drug.
  • Use of third-generation TKIs or major surgical procedures within 3 weeks prior to the first dose of the drug.
  • Received palliative intracranial radiotherapy prior to first administration.
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  • Presence of clinically active diverticulitis, abdominal abscesses, gastrointestinal obstruction.
  • Have received a transplant of a solid organ or blood system.
  • Presence of clinically uncontrollable pleural effusion/abdominal fluid.
  • Known severe allergic reaction (≥ grade 3) to TKIs.
  • Have not sufficiently recovered from toxicity and/or complications from any of the interventions prior to initiating treatment (i.e. ≤ grade 1 or at baseline, not including weakness or hair loss).
  • Diagnosis of other malignancies within 5 years prior to the first dose, with exceptions including radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ.
  • Active infections that require systemic treatment.
  • The known existence of a mental illness or substance abuse condition that may affect compliance with the test requirements.
  • Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive).
  • Evidence of a medical history or illness that could interfere with the results of the trial, prevent the subject from participating throughout the study, abnormal values for treatment or laboratory tests, or other circumstances that, in the opinion of the investigator, make enrollment unsuitable.
  • Breastfeeding women.

Trial locations and contacts

1 site in 1 country.

JIAYAN CHEN contact

+8618121299483

chenjiayan2008@126.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Jiayan Chen, MD, 18121299483, chenjiayan2008@126.com

    Recruiting

Other trials in China

About this study

Official title: Efficacy of SRT as Salvage Therapy in Patients With Brain Oligo-progression of EGFR-mutant Non-small Cell Lung Cancer After Failure of the Third-generation EGFR-TKIs: A Multicenter, Open Label, Phase II Clinical Study

About 20%-40% of NSCLC patients develop intracranial metastases, and most clinical studies suggest that the survival of lung cancer patients will be significantly shortened once they develop intracranial metastases. EGFR tyrosine kinase inhibitors (EGFR-TKIs) remain the standard first-line therapy for patients with advanced EGFR-mutated NSCLC, including brain metastases(EGFR BMs). The survival rate of NSCLC patients with EGFR BMs was significantly improved compared with that of mutation-free patients. Third-generation EGFR-TKIs have unique advantages in the treatment of NSCLC BMs due to their improved blood-brain barrier permeability, and with the development of radiotherapy technology, stereotactic radiation therapy (SRT) has also demonstrated its remarkable qualities of high efficiency and low toxicity in a limited number of intracranial metastases. The clinical mechanisms of resistance to third-generation EGFR-TKIs are far more complex than those of first-generation TKIs, and the treatment paradigm for disease progression including intracranial progression is challenging. It would be interesting to design prospective clinical studies of patients with EGFR BMs treated with the third-generation TKIs followed by salvage SRT for oligo-progression. Therefore, the investigator designed this prospective, phase II clinical study of intracranial oligo-progression applied with stereotactic radiotherapy as salvage therapy in EGFR BMs patients after failure of the third-generation EGFR-TKIs.

Being tested
Aumolertinib Oral Tablet
Medical subject headings
Lung Neoplasms

What participants receive

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

  • Aumolertinib Oral TabletDrug

    Also called Stereotactic Radiation Therapy

    Aumolertinib 110 mg p.o. qd+ SRT(32Gy/4fx)

Study groups in NCT04519983
Study groupRoleWhat they receive
Upfront TKI + Salvage SRTExperimentalPatients With Brain metastases of EGFR-mutant Non-small Cell Lung Cancer should receive Aumolertinib as upfront treatment. SRT(32Gy/4fx) is given to progressive or recurrent intracranial lesions as salvage therapy after intracranial failure.
Receives: Drug: Aumolertinib Oral Tablet

What is being measured

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

  1. Intracranial objective response rate (iORR)

    the rate at which intracranial lesions experience complete and partial remission compared to baseline

    Measured: 2 years

  2. Intracranial progression-free survival (iPFS)

    the time between receiving treatment, observing intracranial disease progression or occurrence of death from any cause, two orders of iPFS will be available in this study analysis. Patients who are still alive at the time of analysis will have the date of their last contact as the cut-off date.

    Measured: 2 years

Secondary outcomes (1)

  1. Overall survival (OS)

    the time between receiving treatment, observing disease progression at any site, or occurrence of death from any cause, there will be two orders of PFS available for analysis in this study. Patients who are still alive at the time of analysis will have the date of their last contact as their cut-off date.

    Measured: 2years

Timeline

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

  1. First posted20 Aug 2020
  2. Study start1 Jan 2022
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion15 Dec 2023 (estimated)

Resources

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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04519983
Sponsor's protocol ID
FUSCC-BMSA
Status last verified
Mar 2023
First submitted
17 Aug 2020
Last updated
20 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aumolertinib Oral Tablet in people with Lung Cancer Stage IV, run by Shanghai Cancer Hospital, 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 16 inclusion and 17 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 20 Mar 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 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 JIAYAN CHEN (+8618121299483, chenjiayan2008@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intracranial objective response rate (iORR) (time frame: 2 years). 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?

On the ClinicalTrials.gov record for NCT04519983.

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 20 Mar 2023.

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