EGFRPhase 3NCT06956001
Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for NSCLC With EGFR PACC or EGFR l861q Mutation
A Phase 3 study testing Firmonertinib Mesilate Tablets, Pemetrexed Disodium for Injection and Cisplatin for injection in people with EGFR and NSCLC (Advanced Non-small Cell Lung Cancer), run by Allist Pharmaceuticals, Inc. at 2 sites in China.
Trial summary
This study is a randomized, open, multicenter phase III clinical study, which aims to evaluate the efficacy and safety of firmonertinib mesylate compared with platinum based chemotherapy for patients with locally advanced or metastatic NSCLC who have not been treated with systemic antitumor therapy and carry EGFR PaCC… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR, NSCLC (Advanced Non-small Cell Lung Cancer)
- What is being tested?
- Firmonertinib Mesilate Tablets, Pemetrexed Disodium for Injection and Cisplatin for injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesChina
- Study dates
- 19 Nov 2024to Jul 2028
- 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
- Voluntarily sign the informed consent form (ICF).
- Age ≥18 years at the time of ICF signing.
- At least one measurable lesion per RECIST v1.1, meeting the following:
- No prior local therapy (e.g., radiotherapy)
- Not used for biopsy during screening
- Histologically/cytologically confirmed non-squamous NSCLC, classified as:
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- Locally advanced (Stage IIIB/IIIC, unsuitable for curative surgery and/or definitive chemoradiotherapy)
- Metastatic (Stage IV) (Based on UICC/AJCC 8th edition TNM staging)
- Agreement to provide:
- Recent tumor tissue (from untreated lesions)
- Blood samples
- Central lab-confirmed EGFR PACC or L861Q mutation (If tumor tissue is unavailable due to inaccessible lesions, sponsor consultation is required.)
- No prior systemic therapy for advanced/metastatic NSCLC.
- Allowed if: Prior (neo)adjuvant/definitive chemoradiotherapy completed ≥12 months before recurrence/progression
- ECOG performance status 0-1.
- Life expectancy ≥12 weeks.
- Adequate bone marrow/organ function within 14 days before treatment (no transfusion/G-CSF within 2 weeks prior).
- Women of childbearing potential (WOCBP):
- Abstinence or contraception use
- No egg donation
- Non-sterilized males:
- Abstinence or contraception use
- No sperm donation
- CNS metastases allowed if protocol-specified criteria are met.
Who cannot join
- Histologically/cytologically confirmed tumor with >10% neuroendocrine carcinoma, sarcomatoid carcinoma, or squamous cell components.
- Known ALK-positive, ROS1-positive, RET fusion-positive, NTRK fusion-positive, BRAF V600E mutation, MET exon 14 skipping mutation, or other targetable alterations with approved therapies.
- Prior treatments including:
- Systemic anti-tumor therapy for advanced/metastatic NSCLC (e.g., chemotherapy/targeted/immunotherapy). Neoadjuvant/adjuvant therapy exceptions per Inclusion Criterion #6.
- >30 Gy thoracic radiotherapy within 6 months or non-thoracic radiotherapy within 4 weeks prior to first dose (brain radiotherapy exceptions per Inclusion Criterion #12).
- Any prior EGFR-targeted therapy (including investigational EGFR-TKIs, mAbs, bispecific antibodies, etc.).
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- Strong CYP3A4 inhibitors within 7 days or inducers within 21 days prior to first dose.
- Anticancer traditional Chinese medicines within 2 weeks prior to first dose.
- Non-specific immunomodulators (e.g., interferon, IL-2, thymosin) within 2 weeks prior to first dose.
- Major trauma/surgery within 4 weeks prior to treatment initiation.
- Clinically significant gastrointestinal abnormalities, including:
- Moderate/severe atrophic gastritis
- GI obstruction/perforation
- Chronic diarrhea/short bowel syndrome
- Major upper GI surgery (e.g., gastrectomy)
- Inflammatory bowel disease (Crohn's/ulcerative colitis) or active intestinal inflammation
- Inability to swallow tablets
- Uncontrolled systemic diseases.
- Severe acute/chronic infections.
- Interstitial lung disease (ILD)/non-infectious pneumonia:
- History requiring clinical intervention
- Current presence
- Suspicious imaging findings unresolved at screening
- Clinically significant cardiovascular dysfunction (active or history).
- Tumor invasion of critical adjacent structures (heart/esophagus/SVC etc.) with high bleeding/fistula risk. Exceptions may be considered if investigator assesses minimal risk.
- Pulmonary comorbidities causing severe impairment, including:
- Baseline lung diseases (e.g., pulmonary embolism [≤3 months], severe asthma/COPD/restrictive disease)
- Autoimmune/connective tissue disorders with pulmonary involvement (e.g., rheumatoid arthritis, sarcoidosis)
- Residual toxicity >Grade 1 (per NCI CTCAE v5.0) from prior anticancer therapy (except alopecia/neuropathy).
- Concurrent malignancies except:
- Cured localized skin cancers (BCC/SCC), superficial bladder cancer, cervical/breast DCIS, or papillary thyroid cancer
- Other malignancies cured by radical therapy ≥3 years prior
- Pregnancy/lactation or planned pregnancy within 6 months post-treatment.
- Inability to comply with study procedures/follow-up.
- Known hypersensitivity to furmonertinib or excipients.
- History of allergic reactions to pemetrexed/cisplatin/carboplatin.
- Other exclusionary per investigator judgment, including:
- Alcohol/drug abuse
- Severe comorbidities (including psychiatric) requiring treatment
- Critical laboratory abnormalities
- Social/familial factors compromising safety/data collection
Trial locations and contacts
2 sites 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
China2 sites, 2 recruiting
- Recruiting
Ethics Committee of cancer hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Wu DaWei DaWei Wu，EC secretary, 8610-87788495, cancergcp@163.com
- Recruiting
Shandong Tumor Hospital
Shandong, Jinan
Shandong Tumor Hospital Shandong Tumor Hospital, 0531-67626929, sdzlllh803@126.com
About this study
Official title: A Phase III, Randomized, Multicentre, Open Label Study to Assess the Efficacy and Safety of Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients With EGFR PACC Mutation or EGFR l861q Mutation
This study is a randomized, open, multicenter phase III clinical study, which aims to evaluate the efficacy and safety of firmonertinib mesylate compared with platinum based chemotherapy for patients with locally advanced or metastatic NSCLC who have not been treated with systemic antitumor therapy and carry EGFR PaCC mutation or EGFR l861q mutation.
Eligible patients were stratified by EGFR mutation type and CNS metastasis at the time of enrollment. Approximately 300 patients would be randomly assigned 1:1 to receive either firmonertinib mesylate (240mg, orally on an empty stomach daily) or platinum containing dual agent chemotherapy.
- Conditions
- EGFR, NSCLC (Advanced Non-small Cell Lung Cancer)
- Being tested
- Firmonertinib Mesilate Tablets, Pemetrexed Disodium for Injection, Cisplatin for injection, Carboplatin Injection
- Keywords
- firmonertinib
- 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.
Firmonertinib Mesilate TabletsDrug
Usage and dosage: oral, 240mg, QD。 Medication duration: 21 days as a cycle, until intolerable toxicity, loss of clinical benefit, disease progression (confirmed by BICR), death or other anti-tumor treatment (whichever occurs first).
Pemetrexed Disodium for InjectionDrug
Usage and dosage: 500mg/m2, intravenous infusion. Medication duration: 21 days as a cycle, D1 administration, until the occurrence of intolerable toxicity, loss of clinical benefit, disease progression (confirmed by BICR), death or other anti-tumor treatment (whichever occurs first).
Cisplatin for injectionDrug
Usage and dosage: 75 mg/m2, i.v. Medication duration: 21 days as a cycle, D1 administration, up to 4 cycles.
Carboplatin InjectionDrug
Usage and dosage: give the drug according to AUC 5 mg/ml, intravenous drip.
Medication duration: 21 days as a cycle, D1 administration, up to 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Firmonertinib | Experimental | Oral administration, 240mg, QD。 Receives: Drug: Firmonertinib Mesilate Tablets |
| chemotherapy | Active comparator | Pemetrexed Disodium for Injection： 500mg/m2, intravenous infusion. Cisplatin for injection：75 mg/m2， intravenous infusion. Carboplatin Injection：administered according to the AUC of 5 mg/ml, intravenous infusion. Receives: Drug: Pemetrexed Disodium for Injection; Drug: Cisplatin for injection; Drug: Carboplatin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) assessed by the Independent Review Committee (BICR) according to RECIST v1.1.
The time from the date of randomization to the date of first documentation of disease progression (assessed according to RECIST v1.1 criteria) or death from any cause, whichever occurred first.
Measured: Up to 3 years
Secondary outcomes (5)
Overall survival (OS)
Measured: Up to 3 years
The incidence and severity of adverse events (AES) were determined according to NCI CTCAE V5.0
Measured: Up to 3 years
Patient Reported Outcomes by EORTC QLQ LC13 questionnaire
To assess the impact of firmonertinib on patients' disease-related symptoms and health related quality of life (HRQoL).
Measured: Up to 3 years
Patient Reported Outcomes by EORTC QLQ-C30 questionnaire
To assess the impact of firmonertinib on patients' disease-related symptoms and health related quality of life (HRQoL).
Measured: Up to 3 years
Plasma concentrations of firmonertinib and its major metabolite (ast5902) in patients treated with firmonertinib at the indicated sampling time points
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start19 Nov 2024
- Primary completionDec 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFRStudies of the same condition, open and under way.
- More trials run by Allist Pharmaceuticals, Inc.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allist Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956001
- Sponsor's protocol ID
- ALSC013AST2818
- 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Multicentre, Open Label Study to Assess the Efficacy and Safety of Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients With EGFR PACC Mutation or EGFR l861q Mutation
- ClinicalTrials.gov ID
- NCT06956001
- Acronym / sponsor ID
- ALSC013AST2818
- Conditions
- EGFR, NSCLC (Advanced Non-small Cell Lung Cancer)
- Keywords
- firmonertinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Allist Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 2 May 2025 (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.
This study is a randomized, open, multicenter phase III clinical study, which aims to evaluate the efficacy and safety of firmonertinib mesylate compared with platinum based chemotherapy for patients with locally advanced or metastatic NSCLC who have not been treated with systemic antitumor therapy and carry EGFR PaCC mutation or EGFR l861q mutation.
Eligible patients were stratified by EGFR mutation type and CNS metastasis at the time of enrollment. Approximately 300 patients would be randomly assigned 1:1 to receive either firmonertinib mesylate (240mg, orally on an empty stomach daily) or platinum containing dual agent chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Firmonertinib | Experimental | Drug: Firmonertinib Mesilate TabletsOral administration, 240mg, QD。 |
| chemotherapy | Active comparator | Drug: Pemetrexed Disodium for Injection, Drug: Cisplatin for injection, Drug: Carboplatin InjectionPemetrexed Disodium for Injection： 500mg/m2, intravenous infusion. Cisplatin for injection：75 mg/m2， intravenous infusion. Carboplatin Injection：administered according to the AUC of 5 mg/ml, intravenous infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Voluntarily sign the informed consent form (ICF).
- Age ≥18 years at the time of ICF signing.
- At least one measurable lesion per RECIST v1.1, meeting the following:
- Histologically/cytologically confirmed non-squamous NSCLC, classified as:
- Agreement to provide:
Key exclusion criteria (41 listed)
- Histologically/cytologically confirmed tumor with >10% neuroendocrine carcinoma, sarcomatoid carcinoma, or squamous cell components.
- Known ALK-positive, ROS1-positive, RET fusion-positive, NTRK fusion-positive, BRAF V600E mutation, MET exon 14 skipping mutation, or other targetable alterations with approved therapies.
- Prior treatments including:
- Clinically significant gastrointestinal abnormalities, including:
- Uncontrolled systemic diseases.
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 |
|---|---|---|
| Firmonertinib Mesilate TabletsUsage and dosage: oral, 240mg, QD。 Medication duration: 21 days as a cycle, until intolerable toxicity, loss of clinical benefit, disease progression (confirmed by BICR), death or other anti-tumor treatment (whichever occurs first). | Drug | Firmonertinib |
| Pemetrexed Disodium for InjectionUsage and dosage: 500mg/m2, intravenous infusion. Medication duration: 21 days as a cycle, D1 administration, until the occurrence of intolerable toxicity, loss of clinical benefit, disease progression (confirmed by BICR), death or other anti-tumor treatment (whichever occurs first). | Drug | chemotherapy |
| Cisplatin for injectionUsage and dosage: 75 mg/m2, i.v. Medication duration: 21 days as a cycle, D1 administration, up to 4 cycles. | Drug | chemotherapy |
| Carboplatin InjectionUsage and dosage: give the drug according to AUC 5 mg/ml, intravenous drip. Medication duration: 21 days as a cycle, D1 administration, up to 4 cycles. | Drug | chemotherapy |
Primary outcome
Progression-free survival (PFS) assessed by the Independent Review Committee (BICR) according to RECIST v1.1.
Time frame: Up to 3 years
The time from the date of randomization to the date of first documentation of disease progression (assessed according to RECIST v1.1 criteria) or death from any cause, whichever occurred first.
5 secondary outcomes
Overall survival (OS)
Time frame: Up to 3 years
The incidence and severity of adverse events (AES) were determined according to NCI CTCAE V5.0
Time frame: Up to 3 years
Patient Reported Outcomes by EORTC QLQ LC13 questionnaire
Time frame: Up to 3 years
Patient Reported Outcomes by EORTC QLQ-C30 questionnaire
Time frame: Up to 3 years
Plasma concentrations of firmonertinib and its major metabolite (ast5902) in patients treated with firmonertinib at the indicated sampling time points
Time frame: Up to 3 years
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 13 Aug 2026.
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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.
Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Firmonertinib Mesilate Tablets, Pemetrexed Disodium for Injection and Cisplatin for injection in people with EGFR and NSCLC (Advanced Non-small Cell Lung Cancer), run by Allist Pharmaceuticals, Inc. at 2 sites 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 24 inclusion and 41 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 2 sites 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?
Progression-free survival (PFS) assessed by the Independent Review Committee (BICR) according to RECIST v1.1. (time frame: Up to 3 years). 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 13 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.