Status:
RECRUITING
Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for NSCLC With EGFR PACC or EGFR l861q Mutation
Lead Sponsor:
Allist Pharmaceuticals, Inc.
Conditions:
EGFR
NSCLC (Advanced Non-small Cell Lung Cancer)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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:
- 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.
Exclusion
- 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.).
- 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
Key Trial Info
Start Date :
November 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06956001
Start Date
November 19 2024
End Date
July 1 2028
Last Update
May 2 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Ethics Committee of cancer hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
2
Shandong Tumor Hospital
Shandong, Jinan, China