Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for NSCLC With EGFR PACC or EGFR l861q Mutation
NCT ID: NCT06956001
Last Updated: 2025-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2024-11-19
2028-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Firmonertinib
Oral administration, 240mg, QD。
Firmonertinib Mesilate Tablets
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).
chemotherapy
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.
Pemetrexed Disodium for Injection
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 injection
Usage and dosage: 75 mg/m2, i.v. Medication duration: 21 days as a cycle, D1 administration, up to 4 cycles.
Carboplatin Injection
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.
Interventions
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Firmonertinib Mesilate Tablets
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 Injection
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 injection
Usage and dosage: 75 mg/m2, i.v. Medication duration: 21 days as a cycle, D1 administration, up to 4 cycles.
Carboplatin Injection
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.
Eligibility Criteria
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Inclusion Criteria
2. Age ≥18 years at the time of ICF signing.
3. 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
4. Histologically/cytologically confirmed non-squamous NSCLC, classified as:
* Locally advanced (Stage IIIB/IIIC, unsuitable for curative surgery and/or definitive chemoradiotherapy)
* Metastatic (Stage IV) (Based on UICC/AJCC 8th edition TNM staging)
5. 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.)
6. No prior systemic therapy for advanced/metastatic NSCLC.
* Allowed if: Prior (neo)adjuvant/definitive chemoradiotherapy completed ≥12 months before recurrence/progression
7. ECOG performance status 0-1.
8. Life expectancy ≥12 weeks.
9. Adequate bone marrow/organ function within 14 days before treatment (no transfusion/G-CSF within 2 weeks prior).
10. Women of childbearing potential (WOCBP):
* Abstinence or contraception use
* No egg donation
11. Non-sterilized males:
* Abstinence or contraception use
* No sperm donation
12. CNS metastases allowed if protocol-specified criteria are met.
Exclusion Criteria
2. 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.
3. Prior treatments including:
1. Systemic anti-tumor therapy for advanced/metastatic NSCLC (e.g., chemotherapy/targeted/immunotherapy). Neoadjuvant/adjuvant therapy exceptions per Inclusion Criterion #6.
2. \>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).
3. Any prior EGFR-targeted therapy (including investigational EGFR-TKIs, mAbs, bispecific antibodies, etc.).
4. Strong CYP3A4 inhibitors within 7 days or inducers within 21 days prior to first dose.
5. Anticancer traditional Chinese medicines within 2 weeks prior to first dose.
6. Non-specific immunomodulators (e.g., interferon, IL-2, thymosin) within 2 weeks prior to first dose.
7. Major trauma/surgery within 4 weeks prior to treatment initiation.
4. 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
5. Uncontrolled systemic diseases.
6. Severe acute/chronic infections.
7. Interstitial lung disease (ILD)/non-infectious pneumonia:
* History requiring clinical intervention
* Current presence
* Suspicious imaging findings unresolved at screening
8. Clinically significant cardiovascular dysfunction (active or history).
9. Tumor invasion of critical adjacent structures (heart/esophagus/SVC etc.) with high bleeding/fistula risk. Exceptions may be considered if investigator assesses minimal risk.
10. Pulmonary comorbidities causing severe impairment, including:
1. Baseline lung diseases (e.g., pulmonary embolism \[≤3 months\], severe asthma/COPD/restrictive disease)
2. Autoimmune/connective tissue disorders with pulmonary involvement (e.g., rheumatoid arthritis, sarcoidosis)
11. Residual toxicity \>Grade 1 (per NCI CTCAE v5.0) from prior anticancer therapy (except alopecia/neuropathy).
12. 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
13. Pregnancy/lactation or planned pregnancy within 6 months post-treatment.
14. Inability to comply with study procedures/follow-up.
15. Known hypersensitivity to furmonertinib or excipients.
16. History of allergic reactions to pemetrexed/cisplatin/carboplatin.
17. 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
18 Years
ALL
No
Sponsors
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Allist Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Ethics Committee of cancer hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Shandong Tumor Hospital
Shandong, Jinan, China
Countries
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Central Contacts
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Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd
Role: CONTACT
Facility Contacts
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Other Identifiers
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ALSC013AST2818
Identifier Type: -
Identifier Source: org_study_id
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