Non-small Cell Lung CancerPhase 2NCT06890182
Firmonertinib Combined With Chemotherapy as Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢB EGFR Sensitive Mutanted NSCLC
A Phase 2 study testing Firmonertinib combined with Carboplatin/Cisplatin and Pemetrexed in people with Non-small Cell Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
This is a phase II study aimed to assess the efficacy and safety of firmonertinib combined with carboplatin/cisplatin and pemetrexed as neoadjuvant therapy in stage II-IIIB resectable NSCLC patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Firmonertinib combined with Carboplatin/Cisplatin and Pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Dec 2027
- Phase
- Phase 2
- 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
- Provide informed consent prior to any study specific procedures
- at least 18 years of age
- Histology or cytology diagnose of non-small cell lung cancer within 60 days
- ECOG PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks
- Stage II-IIIB NSCLC that is expected to be resectable, as assessed by the investigator (8 thUICCTNM staging),
- According to RECIST 1.1, patients have at least one measureable tumor lesion (The longest axis ≥10mm)
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- EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)
- Without prior anti-tumor treatment
- Withe adequate organ function of hematology, liver and kidney
- Using adequate and effective contraception, Male patients should be use condoms; women should refrain from breastfeeding and have a negative pregnancy test prior to the first administration of the study drug if within during child-bearing age
Who cannot join
- Dual or multiple primary NSCLC
- Any prior anti-tumor treatment
- With history of other malignancy except for radical resected tumors without recurrence for 5 years or more
- Diseases or clinical states with severe abnormalities of gastrointestinal function that may interfere with the ingestion, transit, or absorption of the study drug.e.g., inability to take medication orally, uncontrolled nausea and vomiting
- With severe or uncontrolled systemic disease such as uncontrolled hypertention, diabetes mellitus, chronic heart failure, unstable angina, myocardial infarction within 1 year, active hemorrhage, active HBV/HCV/HIV or other infections requiring infusion treatment
- Laboratory tests indicate insufficient bone marrow reserve or organ reserve
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- Women with pregnancy or breastfeeding
- Patients with known or suspected drug allergies, or other contraindications
- Other conditions that, in the opinion of the investigator, make participation in this trial inappropriate
- Patients who are currently or previously enrolled in any other anti-tumor clinical study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Firmonertinib Combine With Carboplatin/Cisplatin and Pemetrexed as Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢB EGFR Sensitive Mutanted NSCLC
This is a phase II study aimed to assess the efficacy and safety of firmonertinib combined with carboplatin/cisplatin and pemetrexed as neoadjuvant therapy in stage II-IIIB resectable NSCLC patients.
Read the detailed description
In this open-label, single-arm, phase 2 study, 31 eligible patients with EGFR mutated stage IIIA-IIIB resectable NSCLC will be recruited to receive firmonertinib for 12 weeks combined with carboplatin/cisplatin and pemetrexed for 4 cycles (21 d/cycle) as neoadjuvant therapy before radical surgery. Radiological and pathological evaluations will be performed before and after the neoadjuvant therapy to assess the efficacy of treatment. Adverse events during neoadjuvant therapy, disease and survival status will also be collected in the study.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Firmonertinib combined with Carboplatin/Cisplatin and Pemetrexed
- 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 combined with Carboplatin/Cisplatin and PemetrexedDrug
furmonertinib 80mg/d for 12 weeks and carboplatin AUC5 d1 iv / cisplatin 75mg/m2 d1 iv+ pemetrexed 500mg/m2 d1 iv at 21 day cycles for 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Firmonertinib combined with Carboplatin/Cisplatin and Pemetrexed | Experimental | furmonertinib 80mg/d for 12 weeks and carboplatin AUC5 d1 iv / cisplatin 75mg/m2 d1 iv+ pemetrexed 500mg/m2 d1 iv at 21 day cycles for 4 cycles Receives: Drug: Firmonertinib combined with Carboplatin/Cisplatin and Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological response rate (MPR)
Proportion of resected specimens with ≤10% residual tumor cells assessed by surgical specimen pathology
Measured: Approximately 24 weeks following the first dose of study drug
Secondary outcomes (5)
Pathological Complete Response Rate（pCR)
The proportion of patients with pathological response rate in the resected tumor.
Measured: Approximately 24 weeks following the first dose of study drug
Objective Response Rate (ORR)
According to RECIST 1.1 criteria, after 8 weeks of neoadjuvant therapy CT scans scans assessed the proportion of patients in partial and complete remission.
Measured: Approximately 8 weeks following the first dose of study drug
Rate of R0 Resection
The proportion of patients with R0 resection.
Measured: Approximately 16 weeks following the first dose of study drug
Pathological downstaging of lymph node rate
The proportion of patients with pathological downstaging of lymph node rate
Measured: Approximately 16 weeks following the first dose of study drug
Incidence of adverse events (AE)
The number of patients with adverse events and the severity according to CTCAE v5.0
Measured: Approximately 12 weeks following the first dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhansheng Jiang, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890182
- Sponsor's protocol ID
- E20250016
- Status last verified
- Mar 2025
- First submitted
- 16 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Firmonertinib Combine With Carboplatin/Cisplatin and Pemetrexed as Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢB EGFR Sensitive Mutanted NSCLC
- ClinicalTrials.gov ID
- NCT06890182
- Acronym / sponsor ID
- E20250016
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Mar 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 is a phase II study aimed to assess the efficacy and safety of firmonertinib combined with carboplatin/cisplatin and pemetrexed as neoadjuvant therapy in stage II-IIIB resectable NSCLC patients.
Detailed description
In this open-label, single-arm, phase 2 study, 31 eligible patients with EGFR mutated stage IIIA-IIIB resectable NSCLC will be recruited to receive firmonertinib for 12 weeks combined with carboplatin/cisplatin and pemetrexed for 4 cycles (21 d/cycle) as neoadjuvant therapy before radical surgery. Radiological and pathological evaluations will be performed before and after the neoadjuvant therapy to assess the efficacy of treatment. Adverse events during neoadjuvant therapy, disease and survival status will also be collected in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Firmonertinib combined with Carboplatin/Cisplatin and Pemetrexed | Experimental | Drug: Firmonertinib combined with Carboplatin/Cisplatin and Pemetrexedfurmonertinib 80mg/d for 12 weeks and carboplatin AUC5 d1 iv / cisplatin 75mg/m2 d1 iv+ pemetrexed 500mg/m2 d1 iv at 21 day cycles for 4 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provide informed consent prior to any study specific procedures
- at least 18 years of age
- Histology or cytology diagnose of non-small cell lung cancer within 60 days
- ECOG PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks
- Stage II-IIIB NSCLC that is expected to be resectable, as assessed by the investigator (8 thUICCTNM staging),
Key exclusion criteria (10 listed)
- Dual or multiple primary NSCLC
- Any prior anti-tumor treatment
- With history of other malignancy except for radical resected tumors without recurrence for 5 years or more
- Diseases or clinical states with severe abnormalities of gastrointestinal function that may interfere with the ingestion, transit, or absorption of the study drug.e.g., inability to take medication orally, uncontrolled nausea and vomiting
- With severe or uncontrolled systemic disease such as uncontrolled hypertention, diabetes mellitus, chronic heart failure, unstable angina, myocardial infarction within 1 year, active hemorrhage, active HBV/HCV/HIV or other infections requiring infusion treatment
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 combined with Carboplatin/Cisplatin and Pemetrexedfurmonertinib 80mg/d for 12 weeks and carboplatin AUC5 d1 iv / cisplatin 75mg/m2 d1 iv+ pemetrexed 500mg/m2 d1 iv at 21 day cycles for 4 cycles | Drug | Firmonertinib combined with Carboplatin/Cisplatin and Pemetrexed |
Primary outcome
Major pathological response rate (MPR)
Time frame: Approximately 24 weeks following the first dose of study drug
Proportion of resected specimens with ≤10% residual tumor cells assessed by surgical specimen pathology
5 secondary outcomes
Pathological Complete Response Rate（pCR)
Time frame: Approximately 24 weeks following the first dose of study drug
Objective Response Rate (ORR)
Time frame: Approximately 8 weeks following the first dose of study drug
Rate of R0 Resection
Time frame: Approximately 16 weeks following the first dose of study drug
Pathological downstaging of lymph node rate
Time frame: Approximately 16 weeks following the first dose of study drug
Incidence of adverse events (AE)
Time frame: Approximately 12 weeks following the first dose of study drug
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 21 Mar 2025.
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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.
Zhansheng Jiang principal investigator
Tianjin Medical University Cancer Institute and Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Firmonertinib combined with Carboplatin/Cisplatin and Pemetrexed in people with Non-small Cell Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital.
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 10 inclusion and 10 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: opening soon, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Zhansheng Jiang (13512035574, 18526812877@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathological response rate (MPR) (time frame: Approximately 24 weeks following the first dose of study drug). 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 21 Mar 2025.