NSCLC Stage IVPhase 2TROP-LUNGNCT07548060
A Phase II Study of Sacituzumab Tirumotecan in Combination With Furmonertinib in Patients With Non-squamous Non-Small Cell Lung Cancer Who Have Progressed After EGFR-TKI and Platinum-Based Chemotherapy
A Phase 2 study testing sacituzumab tirumotecan in people with NSCLC Stage IV and EGFR Gene Mutation, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Efficacy and Safety of Sacituzumab Tirumotecan Combined with Furmonertinib in Patients with Locally Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Who Have Progressed After EGFR-TKI and Platinum-Based Chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC Stage IV, EGFR Gene Mutation
- What is being tested?
- sacituzumab tirumotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 22 Jan 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed non-squamous NSCLC that is locally advanced (Stage ⅢB/ⅢC) or metastatic (Stage Ⅳ) and not amenable to curative surgery and/or curative concurrent/sequential chemoradiotherapy [according to the 8th edition TNM staging system for lung cancer by the Union for International Cancer Control (UICC) and American Joint Committee on Cancer (AJCC)], with tissue or blood-based genetic testing showing EGFR-sensitive mutations (19del and L858R).
- Subjects must have received prior EGFR-TKI therapy for locally advanced or metastatic disease and experienced treatment failure (documented radiographic disease progression), and must meet one of the following requirements: a) progressed after first- or second-generation EGFR-TKI, and histologically confirmed T790M-negative after treatment failure; b) progressed after third-generation EGFR-TKI regardless of T790M mutation status; and progressed after platinum-based chemotherapy or have chemotherapy intolerance.
- Note: For subjects who have received neoadjuvant or adjuvant EGFR-TKI therapy, if disease progression occurs ≤12 months from the last dose, this EGFR-TKI is considered first-line therapy for locally advanced or metastatic disease.
- Male or female subjects aged ≥18 years and ≤75 years who have signed the informed consent form.
- ECOG performance status of 0 or 1, with an expected survival >6 months.
- Agree to provide previously stored tumor tissue specimens or undergo biopsy to collect tumor lesion tissue for biomarker analysis.
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- Adequate organ function: Laboratory tests must meet the following requirements: Absolute neutrophil count (ANC) ≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin ≥90 g/L, white blood cell count ≥3.0×10^9/L; Liver function: Total bilirubin <1.5× upper limit of normal (ULN), aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT), and alkaline phosphatase (ALP) ≤2.5×ULN; If liver metastases are present, AST and ALT ≤5.0×ULN; If liver and/or bone metastases are present, ALP ≤5.0×ULN. Renal function: Serum creatinine (Scr) ≤1.5×ULN; Urine routine test shows urine protein <2(+); If baseline urine protein ≥2(+), 24-hour urine protein quantification must be ≤1.0 g; Coagulation function: International normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5×ULN.
- Cardiac function: Left ventricular ejection fraction (LVEF) ≥50%.
- -Able to communicate effectively with the investigator and comply with study requirements for visits, treatment, laboratory tests, and other relevant regulations.
Who cannot join
- Squamous cell carcinoma (including adenosquamous carcinoma and undifferentiated carcinoma); small cell lung cancer (including combined small cell and non-small cell lung cancer); patients who have previously received systemic therapy (prior adjuvant or neoadjuvant therapy is permitted).
- Patients with symptomatic brain metastases at the start of treatment (patients with previously treated brain metastases are eligible if asymptomatic brain metastases persist for at least 4 weeks while on stable dose medication).
- Patients who participated in an interventional oncology clinical trial concurrently during first-line therapy or within 30 days prior to first-line therapy.
- History of tracheoesophageal fistula, gastrointestinal perforation or fistula, or intra-abdominal abscess within 6 months before treatment initiation.
- Patients with severe cardiovascular or cerebrovascular diseases, including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction within 6 months before enrollment, and significant vascular disease (including but not limited to aortic aneurysm requiring surgical repair or recent arterial thrombosis); patients with unstable angina, New York Heart Association (NYHA) class ≥II heart failure; mean resting corrected QT interval (QTc) >470 ms; any clinically significant resting ECG rhythm, conduction, or morphological abnormalities, such as complete left bundle branch block, third-degree heart block, second-degree heart block, interval >250 ms. Any factors increasing the risk of QTc prolongation or arrhythmic events, such as heart failure, electrolyte abnormalities (including: serum/plasma potassium < LLN; serum/plasma magnesium < LLN; serum/plasma calcium < LLN), congenital long QT syndrome, family history of long QT syndrome, or sudden unexplained death in a first-degree relative under 40 years of age, or any concomitant medication known to prolong QT interval and cause torsades de pointes.
- Uncontrolled systemic diseases as determined by the investigator:
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- Poorly controlled diabetes (fasting blood glucose ≥10 mmol/L on two consecutive occasions);
- Poorly controlled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg);
- Presence of symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage (>1 time/week).
- History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment, current ILD or non-infectious pneumonitis, or suspected ILD or non-infectious pneumonitis at screening that cannot be ruled out by imaging examination.
- Clinically significant pulmonary impairment due to concurrent lung disease, including but not limited to any underlying pulmonary disease (such as pulmonary embolism within 3 months before first dosing, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or prior pneumonectomy.
- Subjects with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, gastrointestinal perforation, intra-abdominal abscess, or acute gastrointestinal bleeding.
- Tumor invasion of surrounding vital organs and vessels (such as heart, esophagus, superior vena cava, etc.) or risk of developing tracheoesophageal fistula or esophagopleural fistula.
- Toxicities from prior anti-tumor therapy that have not recovered to ≤Grade 1 (based on NCI CTCAE version 5.0 assessment) or to the level specified in inclusion/exclusion criteria (except for alopecia, fatigue, and other toxicities that the investigator deems pose no safety risk).
- Known or suspected hypersensitivity to furmonertinib and sacituzumab tirumotecan and/or other components of their formulations.
- Women of childbearing potential or male subjects who are unwilling to use effective contraception during the study or for 6 months after the last dose of study drug.
- Active hepatitis B (positive hepatitis B surface antigen (HBsAg) requiring HBV-DNA testing; HBV-DNA ≥500 IU/mL or higher than the lower limit of detection, whichever is higher) or hepatitis C (positive hepatitis C antibody and HCV-RNA higher than the lower limit of detection).
- Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
- Other conditions that the investigator considers unsuitable for enrollment in addition to the above situations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zhanyu Pan contact
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
AND NSCLC, hanyai@163.com
About this study
Official title: Tianjin Medical University Cancer Institute and Hospital
Efficacy and Safety of Sacituzumab Tirumotecan Combined with Furmonertinib in Patients with Locally Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Who Have Progressed After EGFR-TKI and Platinum-Based Chemotherapy.
Read the detailed description
Currently, treatment benefit after EGFR-TKI resistance is limited. Newly published data from the Phase 2 ORCHARD study demonstrated that osimertinib combined with Dato-DXd showed encouraging efficacy and an acceptable safety profile in EGFR-mutated non-small cell lung cancer (NSCLC) patients who progressed after first-line osimertinib therapy, with an ORR of 43%, median PFS of 11.7 months, and median DoR of 20.5 months. A drug of the same class, sacituzumab tirumotecan, exhibited prominent efficacy in the EGFR-mutated population, achieving an ORR of 60.0%, median DoR of 8.7 months, mPFS of 11.5 months, and mOS of 22.7 months, demonstrating promising potential. Furmonertinib is a novel third-generation EGFR-TKI with excellent efficacy and a favorable safety profile. Therefore, this study intends to explore the efficacy and safety of furmonertinib combined with sacituzumab tirumotecan in patients with advanced EGFR-mutated NSCLC, aiming to provide greater survival benefits to patients and to guide clinical practice.
- Conditions
- NSCLC Stage IV, EGFR Gene Mutation
- Being tested
- sacituzumab tirumotecan
- Keywords
- NSCLC, TROP-2 ADC, EGFR-TKI
- 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.
sacituzumab tirumotecanDrug
Also called furmonertinib
Sacituzumab tirumotecan 5 mg/kg by intravenous infusion on Days 1 and Day 15 of each cycle; Furmonertinib mesylate 80 mg once daily.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Experimental | Sacituzumab tirumotecan 5 mg/kg by intravenous infusion on Days 1 and Day 15 of each cycle; Furmonertinib mesylate 80 mg once daily. Receives: Drug: sacituzumab tirumotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
PFS was defined as the time from the initial treatment to the first occurrence of disease progression or all-cause death (whichever occurs first ) assessed by the investigator according to RECIST v1.1.
Measured: up to 24 months
Secondary outcomes (6)
OS
OS was defined as the time from the initial treatment until the date of death due to any cause.
Measured: up to 24 months
ORR
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 before surgery.
Measured: Up to 24 weeks
DCR
The percentage of patients who have achieved CR，PR and SD assessed by BIRC and investigators per RECIST v 1.1
Measured: up to 24 months
Duration of Response (DoR)
From the date that response criteria are first met to the first occurrence of PD as determined by BIRC and investigators per RECIST v1.1 or death from any cause, whichever occurs first
Measured: up to 24 months
Quality of life
To assess the impact of ST on disease related symptoms and health related quality of life (HRQoL) in this patient population using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale
Measured: 1 week before and every 6 weeks after the study date up to 24 months
safety
Incidence and severity of AEs and SAEs (per CTCAE 5.0), and clinically significant abnormal laboratory findings
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 Feb 2026
- Primary completion22 Jan 2028 (estimated)
- Study completion22 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IVStudies 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
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhanyu Pan, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548060
- Sponsor's protocol ID
- Trop-lung
- Acronym
- TROP-LUNG
- Status last verified
- Jan 2026
- First submitted
- 5 Feb 2026
- Last updated
- 23 Apr 2026
- Results posted
- 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tianjin Medical University Cancer Institute and Hospital
- ClinicalTrials.gov ID
- NCT07548060
- Acronym / sponsor ID
- TROP-LUNG / Trop-lung
- Conditions
- NSCLC Stage IV, EGFR Gene Mutation
- Keywords
- NSCLC, TROP-2 ADC, EGFR-TKI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 22 Jan 2028 (estimated)
- Study completion
- 22 Jan 2028 (estimated)
- First posted
- 23 Apr 2026 (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.
Efficacy and Safety of Sacituzumab Tirumotecan Combined with Furmonertinib in Patients with Locally Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Who Have Progressed After EGFR-TKI and Platinum-Based Chemotherapy.
Detailed description
Currently, treatment benefit after EGFR-TKI resistance is limited. Newly published data from the Phase 2 ORCHARD study demonstrated that osimertinib combined with Dato-DXd showed encouraging efficacy and an acceptable safety profile in EGFR-mutated non-small cell lung cancer (NSCLC) patients who progressed after first-line osimertinib therapy, with an ORR of 43%, median PFS of 11.7 months, and median DoR of 20.5 months. A drug of the same class, sacituzumab tirumotecan, exhibited prominent efficacy in the EGFR-mutated population, achieving an ORR of 60.0%, median DoR of 8.7 months, mPFS of 11.5 months, and mOS of 22.7 months, demonstrating promising potential. Furmonertinib is a novel third-generation EGFR-TKI with excellent efficacy and a favorable safety profile. Therefore, this study intends to explore the efficacy and safety of furmonertinib combined with sacituzumab tirumotecan in patients with advanced EGFR-mutated NSCLC, aiming to provide greater survival benefits to patients and to guide clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Drug: sacituzumab tirumotecanSacituzumab tirumotecan 5 mg/kg by intravenous infusion on Days 1 and Day 15 of each cycle; Furmonertinib mesylate 80 mg once daily. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically confirmed non-squamous NSCLC that is locally advanced (Stage ⅢB/ⅢC) or metastatic (Stage Ⅳ) and not amenable to curative surgery and/or curative concurrent/sequential chemoradiotherapy [according to the 8th edition TNM staging system for lung cancer by the Union for International Cancer Control (UICC) and American Joint Committee on Cancer (AJCC)], with tissue or blood-based genetic testing showing EGFR-sensitive mutations (19del and L858R).
- Subjects must have received prior EGFR-TKI therapy for locally advanced or metastatic disease and experienced treatment failure (documented radiographic disease progression), and must meet one of the following requirements: a) progressed after first- or second-generation EGFR-TKI, and histologically confirmed T790M-negative after treatment failure; b) progressed after third-generation EGFR-TKI regardless of T790M mutation status; and progressed after platinum-based chemotherapy or have chemotherapy intolerance.
- Note: For subjects who have received neoadjuvant or adjuvant EGFR-TKI therapy, if disease progression occurs ≤12 months from the last dose, this EGFR-TKI is considered first-line therapy for locally advanced or metastatic disease.
- Male or female subjects aged ≥18 years and ≤75 years who have signed the informed consent form.
- ECOG performance status of 0 or 1, with an expected survival >6 months.
Key exclusion criteria (19 listed)
- Squamous cell carcinoma (including adenosquamous carcinoma and undifferentiated carcinoma); small cell lung cancer (including combined small cell and non-small cell lung cancer); patients who have previously received systemic therapy (prior adjuvant or neoadjuvant therapy is permitted).
- Patients with symptomatic brain metastases at the start of treatment (patients with previously treated brain metastases are eligible if asymptomatic brain metastases persist for at least 4 weeks while on stable dose medication).
- Patients who participated in an interventional oncology clinical trial concurrently during first-line therapy or within 30 days prior to first-line therapy.
- History of tracheoesophageal fistula, gastrointestinal perforation or fistula, or intra-abdominal abscess within 6 months before treatment initiation.
- Patients with severe cardiovascular or cerebrovascular diseases, including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction within 6 months before enrollment, and significant vascular disease (including but not limited to aortic aneurysm requiring surgical repair or recent arterial thrombosis); patients with unstable angina, New York Heart Association (NYHA) class ≥II heart failure; mean resting corrected QT interval (QTc) >470 ms; any clinically significant resting ECG rhythm, conduction, or morphological abnormalities, such as complete left bundle branch block, third-degree heart block, second-degree heart block, interval >250 ms. Any factors increasing the risk of QTc prolongation or arrhythmic events, such as heart failure, electrolyte abnormalities (including: serum/plasma potassium < LLN; serum/plasma magnesium < LLN; serum/plasma calcium < LLN), congenital long QT syndrome, family history of long QT syndrome, or sudden unexplained death in a first-degree relative under 40 years of age, or any concomitant medication known to prolong QT interval and cause torsades de pointes.
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 |
|---|---|---|
| sacituzumab tirumotecanAlso: furmonertinibSacituzumab tirumotecan 5 mg/kg by intravenous infusion on Days 1 and Day 15 of each cycle; Furmonertinib mesylate 80 mg once daily. | Drug | Interventional Arm |
Primary outcome
PFS
Time frame: up to 24 months
PFS was defined as the time from the initial treatment to the first occurrence of disease progression or all-cause death (whichever occurs first ) assessed by the investigator according to RECIST v1.1.
6 secondary outcomes
OS
Time frame: up to 24 months
ORR
Time frame: Up to 24 weeks
DCR
Time frame: up to 24 months
Duration of Response (DoR)
Time frame: up to 24 months
Quality of life
Time frame: 1 week before and every 6 weeks after the study date up to 24 months
safety
Time frame: up to 24 months
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 23 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Zhanyu Pan contact
Zhanyu Pan principal investigator
Tianjin Medical University Cancer Institute and Hospital
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 sacituzumab tirumotecan in people with NSCLC Stage IV and EGFR Gene Mutation, run by Tianjin Medical University Cancer Institute and 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 9 inclusion and 19 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 23 Apr 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?
Contact haiyan Sun (+8613920916450, hanyai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: up to 24 months). 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 23 Apr 2026.