Non-small Cell Lung CancerPhase 2NCT05430802
Neoadjuvant Furmonertinib and Cisplatin/Pemetrexed as in EGFR Mutated Stage IIA-IIIB Resectable NSCLC (FORESEE)
A Phase 2 study testing Furmonertinib+cisplating/pemetrexed in people with Non-small Cell Lung Cancer, run by Tang-Du Hospital at 1 site in China.
Trial summary
In this single-arm, phase II clinical trial, patients with resectable, EGFR-mutated, stage II-IIIB NSCLC received neoadjuvant therapy with furmonertinib (oral, 80 mg once daily, stopped 1 week preoperatively) in combination with platinum-based doublet chemotherapy every 3 weeks for a total of 3 cycles. 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?
- Furmonertinib+cisplating/pemetrexed
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2023to 1 Dec 2029
- 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
- With written informed consent before any study procedure
- Histology or cytology diagnose of non-small cell lung cancer within 60 days
- Stage IIA-IIIB (T3N2M0 only), with resectable lesion(s) by radiology
- EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)
- Without prior anti-tumor treatment
- With at least one measurable lesions
- ECOG performance status 0-1
- Using adequate and effective contraception, 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
- EGFR Exon 20 insertions positive
- Mixed with small cell cancer, or other mixed types of lung cancer
- Any prior anti-tumor treatment
- Major surgery within 4 weeks before enrollment
- Women with pregnancy or breastfeeding
- Use of strong CYP3A4 inhibitors within 7 days or strong CYP3A4 inducers within 21 days before enrollment; use of traditional Chinese medicine with anti-tumor effect within 21 days before enrollment
Show all 15Show fewer
- With history of other malignancy except for radical resected tumors without recurrence for 5 years or more
- 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
- Severe gastrointestinal diseases which may affect the intake and absorption of study drug
- Prolongation of ECG QTc or with relative risk factors
- History of interstitial lung disease or with relative risk factors
- Inadequate organ function of hematology, liver and kidney
- Allergic to study drugs or any component
- Poor adherence or other situation judged by investigator
- Patients who had participated other clinical studies of tumors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Furmonertinib Combined With Cisplatin/Pemetrexed as Neoadjuvant Therapy in EGFR Mutated Stage IIA-IIIB Resectable Non-small Cell Lung Cancer (FORESEE): a Prospective, Open-label, Single-arm, Phase 2 Study
In this single-arm, phase II clinical trial, patients with resectable, EGFR-mutated, stage II-IIIB NSCLC received neoadjuvant therapy with furmonertinib (oral, 80 mg once daily, stopped 1 week preoperatively) in combination with platinum-based doublet chemotherapy every 3 weeks for a total of 3 cycles. Surgery was performed 4-6 weeks after chemotherapy. The primary endpoint was objective response rate (ORR). Secondary endpoints included the pathological complete response (pCR) rate, major pathological response (MPR) rate, TNM downstaging rate, R0 resection rate, EFS, overall survival (OS), drug safety and surgical complications.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Furmonertinib+cisplating/pemetrexed
- Keywords
- furmonertinib, AST2818
- 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.
Furmonertinib+cisplating/pemetrexedDrug
Furmonertinib 80mg/d for 9 weeks and cisplating75mg/m2 d1 iv + pemetrexed 500mg/m2 d1 iv in 21-day cycles for 3 cycles
| Study group | Role | What they receive |
|---|---|---|
| furmonertinib plus platinum-based doublet chemotherapy | Experimental | furmonertinib (oral, 80 mg once daily, stopped 1 week preoperatively) in combination with platinum-based doublet chemotherapy every 3 weeks for a total of 3 cycles Receives: Drug: Furmonertinib+cisplating/pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
the proportion of patients achieving complete response (CR) or partial response (PR) as assessed by investigators according to RECIST version 1.1
Measured: 7 days before surgery
Secondary outcomes (7)
Major pathological response rate
MPR was defined as the presence of ≤10% residual viable tumor cells in the primary tumor and all lymph nodes from surgical specimens following R0 resection, and the MPR rate was subsequently calculated as the proportion of patients who achieved MPR
Measured: 7 days after surgery
Pathological complete response rate
pCR was defined as the absence of viable tumor cells in the primary tumor and all sampled regional lymph nodes from surgical specimens following R0 resection, and the pCR rate was calculated as the proportion of patients achieving this response
Measured: 7 days after surgery
R0 resection rate
the proportion of patients achieving R0 resection among all patients undergoing tumor resection surgery
Measured: 7 days after surgery
the TNM downstaging rate
defined as the proportion of patients whose post-neoadjuvant therapy TNM stage (prior to surgery) was lower than their baseline TNM stage
Measured: 7 days before surgery
Event-free survival
defined as the time from the date of informed consent to loss of surgical eligibility due to disease progression, postoperative recurrence, or death from any cause
Measured: 2 years
Overall survival
The time from enrolment to death of any reason
Measured: Approximately 5 years following the first dose of study drugs
drug safety and surgical complications
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 and Number of participants with surgical complications as assessed by Clavien-Dindo
Measured: Adverse events (AEs) will be followed up for 30 days, serious adverse events (SAEs) will be followed up until resolution (assessed up to 60 days), and surgical complications will be followed up for 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start10 Jan 2023
- Primary completion1 Sep 2025
- Study completion1 Dec 2029 (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 Tang-Du 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430802
- Sponsor's protocol ID
- PMR-21011
- Status last verified
- Sep 2026
- First submitted
- 20 Jun 2022
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Furmonertinib Combined With Cisplatin/Pemetrexed as Neoadjuvant Therapy in EGFR Mutated Stage IIA-IIIB Resectable Non-small Cell Lung Cancer (FORESEE): a Prospective, Open-label, Single-arm, Phase 2 Study
- ClinicalTrials.gov ID
- NCT05430802
- Acronym / sponsor ID
- PMR-21011
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- furmonertinib, AST2818
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 24 Jun 2022 (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.
In this single-arm, phase II clinical trial, patients with resectable, EGFR-mutated, stage II-IIIB NSCLC received neoadjuvant therapy with furmonertinib (oral, 80 mg once daily, stopped 1 week preoperatively) in combination with platinum-based doublet chemotherapy every 3 weeks for a total of 3 cycles. Surgery was performed 4-6 weeks after chemotherapy. The primary endpoint was objective response rate (ORR). Secondary endpoints included the pathological complete response (pCR) rate, major pathological response (MPR) rate, TNM downstaging rate, R0 resection rate, EFS, overall survival (OS), drug safety and surgical complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| furmonertinib plus platinum-based doublet chemotherapy | Experimental | Drug: Furmonertinib+cisplating/pemetrexedfurmonertinib (oral, 80 mg once daily, stopped 1 week preoperatively) in combination with platinum-based doublet chemotherapy every 3 weeks for a total of 3 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- With written informed consent before any study procedure
- Histology or cytology diagnose of non-small cell lung cancer within 60 days
- Stage IIA-IIIB (T3N2M0 only), with resectable lesion(s) by radiology
- EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)
- Without prior anti-tumor treatment
Key exclusion criteria (15 listed)
- EGFR Exon 20 insertions positive
- Mixed with small cell cancer, or other mixed types of lung cancer
- Any prior anti-tumor treatment
- Major surgery within 4 weeks before enrollment
- Women with pregnancy or breastfeeding
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 |
|---|---|---|
| Furmonertinib+cisplating/pemetrexedFurmonertinib 80mg/d for 9 weeks and cisplating75mg/m2 d1 iv + pemetrexed 500mg/m2 d1 iv in 21-day cycles for 3 cycles | Drug | furmonertinib plus platinum-based doublet chemotherapy |
Primary outcome
Objective response rate
Time frame: 7 days before surgery
the proportion of patients achieving complete response (CR) or partial response (PR) as assessed by investigators according to RECIST version 1.1
7 secondary outcomes
Major pathological response rate
Time frame: 7 days after surgery
Pathological complete response rate
Time frame: 7 days after surgery
R0 resection rate
Time frame: 7 days after surgery
the TNM downstaging rate
Time frame: 7 days before surgery
Event-free survival
Time frame: 2 years
Overall survival
Time frame: Approximately 5 years following the first dose of study drugs
drug safety and surgical complications
Time frame: Adverse events (AEs) will be followed up for 30 days, serious adverse events (SAEs) will be followed up until resolution (assessed up to 60 days), and surgical complications will be followed up for 90 days.
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 25 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Furmonertinib+cisplating/pemetrexed in people with Non-small Cell Lung Cancer, run by Tang-Du Hospital 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 8 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 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 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 7 days before surgery). 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 25 Sep 2026.