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NSCLC Patients With Brain MetastasisPhase 3NCT06970639

A Study Evaluating Furmonertinib Plus Platinum-based Doublet Chemotherapy Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Sensitizing Mutation-Positive Non-squamous Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases

A Phase 3 study testing Furmonertinib Mesilate Tablets, Carboplatin Injection and Cisplatin for injection in people with NSCLC Patients With Brain Metastasis, run by Allist Pharmaceuticals, Inc. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a Phase III, international, multicenter, randomized, controlled, open-label clinical trial. The primary objective is to evaluate the efficacy and safety of furmonertinib plus platinum-based doublet chemotherapy (Arm A) versus osimertinib monotherapy (Arm B) in patients with EGFR sensitizing… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC Patients With Brain Metastasis
What is being tested?
Furmonertinib Mesilate Tablets, Carboplatin Injection and Cisplatin for injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
380 participants
Where
1 siteChina
Study dates
26 Sep 2024to Sep 2029
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Fully understand the trial and voluntarily sign the informed consent form;
  • Age ≥18 years at the time of signing ICF, regardless of gender;
  • Histologically/cytologically confirmed non-squamous NSCLC with brain parenchymal metastases assessed by BICR; Subjects with both brain parenchymal and leptomeningeal metastases are eligible. Subjects without brain metastases may be enrolled in the safety run-in phase.
  • For subjects with brain metastases: clinically stable for ≥4 weeks prior to first dose AND no requirement for corticosteroids/anticonvulsants for ≥14 days prior to first dose; Investigator-confirmed no need for local therapy for brain metastases during screening.
  • Confirmed EGFR sensitizing mutations (ex19del or L858R) via tumor tissue/cytology/blood testing;
  • No prior systemic anti-tumor therapy for advanced/metastatic NSCLC; Subjects who received (neo)adjuvant chemotherapy or definitive chemoradiotherapy must have disease recurrence/progression ≥6 months after completion;
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  • ≥1 measurable intracranial AND extracranial lesion(s) per RECIST v1.1 without prior local treatment;
  • ECOG PS 0-1 with no deterioration within 2 weeks prior to first dose, and life expectancy ≥3 months;
  • Adequate bone marrow and organ function (no transfusion/G-CSF within 2 weeks prior to first dose);
  • All prior treatment-related toxicities resolved to ≤Grade 1 (per NCI CTCAE v5.0) except alopecia (≤Grade 2) or peripheral neuropathy (≤Grade 2);
  • Women of childbearing potential (WOCBP) must have negative serum pregnancy test within 7 days prior to first dose, be non-lactating, and use effective contraception from ICF signing until 6 months after last dose. Male subjects with fertile partners must use contraception during the same period.

Who cannot join

  • The tumor histology or cytology confirmed that the combination of neuroendocrine carcinoma, sarcomatoid carcinoma or squamous cell carcinoma was more than 10%;
  • Known subjects with ALK positive, ros1 positive, RET fusion positive, ntrk fusion positive, BRAF V600 mutation, met exon 14 skipping variant and other approved drugs for this target;
  • Subjects with meningeal metastasis but no brain parenchymal metastasis confirmed by MRI and / or CSF malignant cell examination;
  • Subjects who have previously received any of the following treatments:
  • Have received any systemic anti-tumor therapy targeting EGFR in the past, including those in clinical research stage (including EGFR TKI, monoclonal antibody, bispecific antibody, etc.);
  • Previously received systemic antitumor therapy (such as chemotherapy, targeted therapy, immunotherapy, etc.) for locally advanced / metastatic non-small cell lung cancer;
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  • Received > 30 Gy of chest radiotherapy within 6 months before the first dose; Received non thoracic radiotherapy of >30 Gy within 4 weeks before the first dose; Received palliative radiotherapy ≤ 30Gy within 2 weeks before the first dose; Previous brain radiotherapy;
  • Chinese patent medicine that has received non-specific immune modulators (including but not limited to interferon and IL-2) and approved anti-tumor indications within 2 weeks before the first administration;
  • Have used any strong inhibitor of cytochrome P450 3A4 (CYP3A4) within 7 days before the first administration or any strong inducer of CYP3A4 within 21 days before the first administration;
  • Other malignant tumors in addition to the primary tumor; Skin basal cell or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, breast ductal carcinoma in situ and papillary thyroid cancer that can be treated locally and have been cured can be selected; Subjects with a history of other malignancies and who have been cured for ≥ 3 years after radical treatment can be enrolled;
  • Brain metastasis subjects with known brain stem metastasis, spinal cord metastasis and / or compression; Subjects with acute or progressive intracranial hypertension related symptoms during the screening period; Subjects with brain herniation or near brain herniation; Brain imaging revealed significant brain midline deviation and other subjects requiring urgent local treatment;
  • According to CTCAE 5.0, there were subjects with grade 2 headache, vomiting, papilledema, etc. caused by increased intracranial pressure during the screening period; Subjects with grade 2 sensory / motor impairment and visual field damage caused by brain metastasis during the screening period; Subjects with mental symptoms (such as dementia, sluggish reaction, etc.) or seizures caused by brain metastasis during the screening period; Subjects who can control relevant central nervous system symptoms ≤ 1 grade by steroid hormones or anticonvulsants can be enrolled;
  • The tumor invades the surrounding important organs and blood vessels (such as the heart, esophagus, superior vena cava, etc.) or has the risk of esophago tracheal fistula or esophago pleural fistula;
  • Cardiovascular and cerebrovascular disease or cardiovascular and cerebrovascular risk factors exist.
  • There are uncontrollable systemic diseases.
  • There is a history of (non infectious) interstitial lung disease (ILD) or non infectious pneumonia requiring steroid treatment.
  • Pulmonary complications lead to clinically severe lung damage.
  • Severe acute or chronic infection
  • Subjects who are receiving long-term systemic corticosteroid therapy with prednisone > 10 mg/d or equivalent anti-inflammatory active drugs or any form of immunosuppressive therapy before the first administration [subjects who need bronchodilators, inhaled or topical steroids or local steroid injection therapy, or as preventive medication for hypersensitivity reactions (such as medication before CT examination, etc.), or to control central nervous system symptoms in patients with brain metastasis can be included in the study];
  • Subjects who had undergone major surgery within 4 weeks before the first dose or were expected to undergo major surgery during the study;
  • Bleeding symptoms with significant clinical significance or obvious bleeding tendency within 4 weeks before the first administration.
  • Severe gastrointestinal dysfunction is known.
  • Known or suspected allergy to the ingredients of the study drug or its analogues;
  • Pregnant or lactating women or female subjects who plan to become pregnant during the study or within 6 months after the last dose;
  • In the judgment of the investigator, the subject has other factors that may affect the results of the study or cause the forced termination of the study, such as alcohol abuse, drug abuse, suffering from other serious diseases (including mental diseases) requiring combined treatment, serious abnormal laboratory test values, family or social factors and other conditions that may affect the safety of the subject or the collection of test data.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd contact

021-80423288

zhenhua.gong@allist.com.cn

China1 site, 1 recruiting

  • Guangdong Provincial People's Hospital

    Guangdong, Guangzhou

    Deng Jing Deng Jing, 020-83525173, gdghospital_ec@gdph.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase III, International, Multicenter, Randomized, Controlled, Open-label Clinical Study Evaluating Furmonertinib Plus Platinum-based Doublet Chemotherapy Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Sensitizing Mutation-Positive Non-squamous Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases

This study is a Phase III, international, multicenter, randomized, controlled, open-label clinical trial. The primary objective is to evaluate the efficacy and safety of furmonertinib plus platinum-based doublet chemotherapy (Arm A) versus osimertinib monotherapy (Arm B) in patients with EGFR sensitizing mutation-positive non-squamous non-small cell lung cancer (NSCLC) and brain metastases. Additionally, a proportion of subjects will receive furmonertinib monotherapy (Arm C) to further explore its efficacy and safety profile.

Stage 1 is the safety run-in phase, planned to enroll approximately 30 subjects who will be randomized at a 1:1 ratio to receive either furmonertinib 80 mg QD plus platinum-based chemotherapy or furmonertinib 160 mg QD plus platinum-based chemotherapy, aiming to evaluate the safety and tolerability of different furmonertinib doses in combination with platinum-based chemotherapy.

Stage 2 is the randomized controlled phase, in which approximately 350 subjects will be randomized in a 3:3:1 ratio (Arm A : Arm B : Arm C) to receive the investigational treatments.

Being tested
Furmonertinib Mesilate Tablets, Carboplatin Injection, Cisplatin for injection, Pemetrexed Disodium for Injection, Osimertinib Mesylate Tablets
Keywords
EGFR, firmonertinib

What participants receive

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

  • Furmonertinib Mesilate TabletsDrug

    Usage and dosage: 80mg, 240mg, or 160mg QD orally Medication duration: A cycle of 21 days until intolerable toxicity, disease progression, death, or initiation of new anti-tumor therapy occurs

  • Carboplatin InjectionDrug

    Usage and dosage: Administer via IV infusion, with a dosage of AUC5, not exceeding 750 mg.

    Medication schedule: every 3 weeks as a cycle, D1 administration per cycle, immediate administration of carboplatin upon completion of pemetrexed infusion, intravenous infusion, carboplatin can be used for up to 4 cycles.

  • Cisplatin for injectionDrug

    Usage and dosage: Administer via IV infusion at a dose of 75 mg/m2. Medication schedule: Every 3 weeks as a cycle, with D1 administration per cycle. Cisplatin is administered approximately 30 minutes after the infusion of pemetrexed, via intravenous infusion. Adequate hydration therapy must be received before and after cisplatin treatment. Cisplatin can be used for up to 4 cycles.

  • Pemetrexed Disodium for InjectionDrug

    Usage and dosage: Intravenous (IV) infusion administration, dosage of 500 mg/m2 Medication schedule: Administer on the first day of each cycle (21 days per cycle, i.e. every 3 weeks) until intolerable toxicity, disease progression, death, or initiation of new anti-tumor therapy occurs.

  • Osimertinib Mesylate TabletsDrug

    Usage and dosage: 80mg, QD administration Medication duration: A cycle of 21 days until intolerable toxicity, disease progression, death, or initiation of new anti-tumor therapy occurs

Study groups in NCT06970639
Study groupRoleWhat they receive
Furmonertinib combined with chemotherapyExperimentalFurmonertinib Mesilate Tablets+Carboplatin Injection/Cisplatin for injection+Pemetrexed Disodium for Injection
Receives: Drug: Furmonertinib Mesilate Tablets; Drug: Carboplatin Injection; Drug: Cisplatin for injection; Drug: Pemetrexed Disodium for Injection
Osimertinib Mesylate TabletsActive comparatorOsimertinib Mesylate Tablets
Receives: Drug: Osimertinib Mesylate Tablets

What is being measured

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

  1. Adverse Events (AE)

    Safe import period

    Measured: Up to 4 years

  2. Serious Adverse Event (SAE)

    Safe import period

    Measured: Up to 4 years

  3. Progression-free survival (PFS)

    Randomized Controlled Phase：PFS assessed by BICR based on recist1.1; PFS was defined as the time from the date of randomization to the date of first documented disease progression (assessed according to RECIST v1.1 criteria) or death from any cause, whichever occurred first.

    Measured: Up to 4 years

Secondary outcomes (15)

  1. Progression free survival (PFS) evaluated by researchers based on RECIST 1.1

    Both the safe introduction period and randomized controlled trials require evaluation of progression free survival (PFS)

    Measured: Up to 4 years

  2. Objective response rate (ORR)

    Both the safe introduction period and randomized controlled trials require evaluation of objective response rate (ORR)

    Measured: Up to 4 years

  3. Disease control rate (DCR)

    Both the safe introduction period and randomized controlled trials require evaluation of disease control rate (DCR)

    Measured: Up to 4 years

  4. Duration of Relief (DOR)

    Both the safe introduction period and randomized controlled trials require evaluation of Duration of Relief (DOR)

    Measured: Up to 4 years

  5. Overall survival (OS)

    safe introduction period

    Measured: Up to 4 years

  6. InterPlanetary File System（iPFS） by researchers and BICR based on RECIST 1.1 evaluation

    Randomized Controlled Phase

    Measured: Up to 4 years

  7. Depth of Response（DepOR） by researchers and BICR based on RECIST 1.1 evaluation

    Randomized Controlled Phase

    Measured: Up to 4 years

  8. adverse events (AE)

    Randomized Controlled Phase

    Measured: Up to 4 years

  9. serious adverse events (SAE)

    Randomized Controlled Phase

    Measured: Up to 4 years

  10. Patient Reported Outcomes by EORTC QLQ LC13 questionnaire

    Randomized Controlled Phase：To assess the impact of firmonertinib on patients' disease-related symptoms and health related quality of life (HRQoL).

    Measured: Up to 4 years

  11. Patient Reported Outcomes by EORTCQLQ-C30 questionnaire

    Randomized Controlled Phase：To assess the impact of firmonertinib on patients' disease-related symptoms and health related quality of life (HRQoL).

    Measured: Up to 4 years

  12. Peak Plasma Concentration (Cmax)

    Randomized Controlled Phase

    Measured: Up to 4 years

  13. Steady-state oral clearance（CLss/F）

    Randomized Controlled Phase

    Measured: Up to 4 years

  14. Steady-state minimal concentration（Cmin,ss）

    Randomized Controlled Phase

    Measured: Up to 4 years

  15. Steady-state area under the curve（AUCss）

    Randomized Controlled Phase

    Measured: Up to 4 years

Timeline

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

  1. First posted14 May 2025
  2. Study start26 Sep 2024
  3. Primary completionMar 2029 (estimated)
  4. Study completionSep 2029 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
380 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06970639
Sponsor's protocol ID
ALSC014AST2818
Status last verified
Aug 2026
First submitted
9 Apr 2025
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Furmonertinib Mesilate Tablets, Carboplatin Injection and Cisplatin for injection in people with NSCLC Patients With Brain Metastasis, run by Allist Pharmaceuticals, Inc. 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 25 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: looking for participants now, as of the sponsor's last update on 13 Aug 2026. 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?

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?

Contact Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd (021-80423288, zhenhua.gong@allist.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (AE) (time frame: Up to 4 years). The study lists 3 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 NCT06970639.

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 13 Aug 2026.

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