NSCLC (Non-small Cell Lung Cancer)Phase 2NCT07193160
Sacituzumab Tirumotecan in Combination With Furmonertinib as Second-line Treatment for EGFR-mutant Advanced or Metastatic NSCLC After Failure of First-line Third-generation EGFR-TKI Therapy
A Phase 2 study testing Sacituzumab Tirumotecan and Furmonertinib in people with NSCLC (Non-small Cell Lung Cancer), run by Fudan University.
Trial summary
This study is a multicenter, single-arm, phase II clincial trial. The main objective of the study is to evaluate the efficacy and safety of the combination of Sacituzumab Tirumotecan (sac-TMT) and Furmonertinib in the treatment of EGFR-mutant advanced or metastatic NSCLC after failure of first-line Third-generation… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC (Non-small Cell Lung Cancer)
- What is being tested?
- Sacituzumab Tirumotecan and Furmonertinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 30 May 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Aged 18 to 75 years at the time of signing the informed consent form, regardless of gender; 2. Histologically or cytologically confirmed non-squamous NSCLC, which is locally advanced (Stage ⅢB/ⅢC) or metastatic (Stage Ⅳ) NSCLC that is not suitable for radical surgery and/or radical radiotherapy (whether concurrent chemotherapy is administered or not) [according to the 8th Edition of the Lung Cancer TNM Staging System by the Union for International Cancer Control (UICC) and the American Joint Committee on Cancer (AJCC)]; 3. There must be medical records showing evidence of previous EGFR mutation test results (known presence of EGFR mutations sensitive to EGFR-TKI [Ex19del, L858R], which may exist alone or concurrently with other EGFR mutations, possibly including T790M); 4. Subjects who experienced extracranial radiological progression after achieving remission (CR or PR) or stable disease (SD ≥ 6 months) during the first-line treatment with third-generation EGFR-TKI, but have not received further subsequent treatment (for subjects who received first-line treatment with a third-generation EGFR-TKI other than furmonertinib, the interval between the last dose of the first-line third-generation EGFR-TKI and the first dose of this study must be at least 8 days); 5. The brain metastasis status of subjects at enrollment must meet one of the following conditions:
- No brain metastasis;
- Stable brain metastasis, defined as no central nervous system (CNS) symptoms; or clinically stable for at least 4 weeks before enrollment, with all CNS symptoms returned to the baseline state; no evidence of new or enlarged brain metastatic lesions; and no need for treatment with glucocorticoids or anticonvulsants for at least 2 weeks before enrollment; 6. According to RECIST v1.1, the investigator assesses that there is at least one measurable target lesion that has not been irradiated, is non-central nervous system, and is measurable (if a subject has only one measurable lesion and must undergo tissue biopsy, the baseline tumor assessment needs to be performed at least 14 days after the screening biopsy); 7. Eastern Cooperative Oncology Group (ECOG) Performance Status Score (see Appendix 1 for details) of 0 or 1;
Who cannot join
- 1. Tumor histologically or cytologically confirmed to be combined with small cell lung cancer, neuroendocrine carcinoma, carcinosarcoma components, or squamous cell carcinoma components; 2. Radiologically diagnosed central nervous system (CNS) progression that occurred during or after previous first-line treatment with third-generation EGFR-TKI; 3. Subjects with known meningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, or active central nervous system (CNS) metastasis; 4. Subjects who have previously received systemic antineoplastic therapy (such as chemotherapy and immunotherapy) for locally advanced or metastatic non-squamous NSCLC other than third-generation EGFR-TKI; 5. Previous treatment with TROP2-targeted therapy or any drug therapy targeting topoisomerase Ⅰ, including antibody-drug conjugate (ADC) therapy (including in the context of adjuvant or neoadjuvant therapy); 6. Radiotherapy with a total dose of > 30 Gy administered to lung lesions within 6 months before the first dose; non-thoracic radiotherapy or extensive radiotherapy with a total dose of > 30 Gy administered within 4 weeks before the first dose; palliative radiotherapy for symptom control is allowed, but it must be completed at least 2 weeks before the first dose; 7. History of other malignant tumors within 3 years before the first dose (except for tumors cured by local treatment, such as cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, carcinoma in situ of the cervix, etc.);
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: A Multicenter, Single-arm, Phase II Clinical Study of Sacituzumab Tirumotecan in Combination With Furmonertinib as Second-line Treatment for EGFR-mutant Advanced or Metastatic NSCLC After Failure of First-line Third-generation EGFR-TKI Therapy
This study is a multicenter, single-arm, phase II clincial trial. The main objective of the study is to evaluate the efficacy and safety of the combination of Sacituzumab Tirumotecan (sac-TMT) and Furmonertinib in the treatment of EGFR-mutant advanced or metastatic NSCLC after failure of first-line Third-generation EGFR-TKI therapy.
Read the detailed description
Monotherapy with third-generation EGFR-TKIs has become the standard first-line treatment for advanced NSCLC with EGFR mutations. However, acquired resistance inevitably occurs. ADCs harness the precise targeting and selectivity of monoclonal antibodies while capitalizing on the potent cytotoxic effects of their payload, thereby minimizing off-target toxicity. Sacituzumab Tirumotecan (sac-TMT) is a novel TROP2-directed ADC, had shown encouraging antitumor efficacy in previously treated patients with EGFR mutated advanced NSCLC. Theoretically, combination with small molecule inhibitors (including EGFR-TKI) are one of the combinational strategies for TROP2-ADC with synergistic mechanism.
This study aims to evaluate the efficacy and safety of furmonertinib plus Sacituzumab Tirumotecan in patients with EGFR mutated advanced NSCLC after failure of first-line third-generation EGFR-TKI therapy.
- Conditions
- NSCLC (Non-small Cell Lung Cancer)
- Being tested
- Sacituzumab Tirumotecan, Furmonertinib
- Keywords
- NSCLC, EGFR-mutant, ADC
- 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 sac-TMT, SKB264, MK-2870
fixed dosage 4mg/kg iv, D1, D15, each 4 weeks one cycle. Drug reduction will be implemented according to the research plan.
FurmonertinibDrug
160mg QD or 80mg QD, each 4 weeks one cycle, according to the safety run-in phase, until confirmed by the investigator as imaging disease progression, intolerable toxicity, subject's request to terrminate treatment, or other treatment termination criteria specified in the protocol. Drug reduction will be implemented according to the research plan.
| Study group | Role | What they receive |
|---|---|---|
| sac-TMT + Furmonertinib | Experimental | Not described Receives: Drug: Sacituzumab Tirumotecan; Drug: Furmonertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective Response Rate (ORR) assessed according to the evaluation criteria for the efficacy of RECIST v1.1
Measured: Up to approximately 12 months
Secondary outcomes (4)
Progression Free Survival (PFS)
The time from the beginning of the patient's treatment to the disease progression or death for any reason. Based on RECIST v1.1.
Measured: From treatment administration up to a maximum duration of 12 months.
Duration of Response (DoR)
The time from the first time the evaluation results meet CR or PR criteria to the observation of PD or death.
Measured: Through study completion, an expected average of 12 months.
Disease Control Rate (DCR)
The proportion of subjects with complete response (CR) and partial response (PR) and stable disease (SD) in total subjects after the last subject participating in.
Measured: From treatment administration up to a maximum duration of 12 months.
Overall Survival (OS)
Time from start of treatment to death due to any cause.
Measured: From treatment administration up to a maximum duration of 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jialei Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193160
- Sponsor's protocol ID
- SKB264-IIT-010
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 25 Sep 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 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-arm, Phase II Clinical Study of Sacituzumab Tirumotecan in Combination With Furmonertinib as Second-line Treatment for EGFR-mutant Advanced or Metastatic NSCLC After Failure of First-line Third-generation EGFR-TKI Therapy
- ClinicalTrials.gov ID
- NCT07193160
- Acronym / sponsor ID
- SKB264-IIT-010
- Conditions
- NSCLC (Non-small Cell Lung Cancer)
- Keywords
- NSCLC, EGFR-mutant, ADC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 25 Sep 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 study is a multicenter, single-arm, phase II clincial trial. The main objective of the study is to evaluate the efficacy and safety of the combination of Sacituzumab Tirumotecan (sac-TMT) and Furmonertinib in the treatment of EGFR-mutant advanced or metastatic NSCLC after failure of first-line Third-generation EGFR-TKI therapy.
Detailed description
Monotherapy with third-generation EGFR-TKIs has become the standard first-line treatment for advanced NSCLC with EGFR mutations. However, acquired resistance inevitably occurs. ADCs harness the precise targeting and selectivity of monoclonal antibodies while capitalizing on the potent cytotoxic effects of their payload, thereby minimizing off-target toxicity. Sacituzumab Tirumotecan (sac-TMT) is a novel TROP2-directed ADC, had shown encouraging antitumor efficacy in previously treated patients with EGFR mutated advanced NSCLC. Theoretically, combination with small molecule inhibitors (including EGFR-TKI) are one of the combinational strategies for TROP2-ADC with synergistic mechanism.
This study aims to evaluate the efficacy and safety of furmonertinib plus Sacituzumab Tirumotecan in patients with EGFR mutated advanced NSCLC after failure of first-line third-generation EGFR-TKI therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sac-TMT + Furmonertinib | Experimental | Drug: Sacituzumab Tirumotecan, Drug: Furmonertinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Aged 18 to 75 years at the time of signing the informed consent form, regardless of gender; 2. Histologically or cytologically confirmed non-squamous NSCLC, which is locally advanced (Stage ⅢB/ⅢC) or metastatic (Stage Ⅳ) NSCLC that is not suitable for radical surgery and/or radical radiotherapy (whether concurrent chemotherapy is administered or not) [according to the 8th Edition of the Lung Cancer TNM Staging System by the Union for International Cancer Control (UICC) and the American Joint Committee on Cancer (AJCC)]; 3. There must be medical records showing evidence of previous EGFR mutation test results (known presence of EGFR mutations sensitive to EGFR-TKI [Ex19del, L858R], which may exist alone or concurrently with other EGFR mutations, possibly including T790M); 4. Subjects who experienced extracranial radiological progression after achieving remission (CR or PR) or stable disease (SD ≥ 6 months) during the first-line treatment with third-generation EGFR-TKI, but have not received further subsequent treatment (for subjects who received first-line treatment with a third-generation EGFR-TKI other than furmonertinib, the interval between the last dose of the first-line third-generation EGFR-TKI and the first dose of this study must be at least 8 days); 5. The brain metastasis status of subjects at enrollment must meet one of the following conditions:
Key exclusion criteria (1 listed)
- 1. Tumor histologically or cytologically confirmed to be combined with small cell lung cancer, neuroendocrine carcinoma, carcinosarcoma components, or squamous cell carcinoma components; 2. Radiologically diagnosed central nervous system (CNS) progression that occurred during or after previous first-line treatment with third-generation EGFR-TKI; 3. Subjects with known meningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, or active central nervous system (CNS) metastasis; 4. Subjects who have previously received systemic antineoplastic therapy (such as chemotherapy and immunotherapy) for locally advanced or metastatic non-squamous NSCLC other than third-generation EGFR-TKI; 5. Previous treatment with TROP2-targeted therapy or any drug therapy targeting topoisomerase Ⅰ, including antibody-drug conjugate (ADC) therapy (including in the context of adjuvant or neoadjuvant therapy); 6. Radiotherapy with a total dose of > 30 Gy administered to lung lesions within 6 months before the first dose; non-thoracic radiotherapy or extensive radiotherapy with a total dose of > 30 Gy administered within 4 weeks before the first dose; palliative radiotherapy for symptom control is allowed, but it must be completed at least 2 weeks before the first dose; 7. History of other malignant tumors within 3 years before the first dose (except for tumors cured by local treatment, such as cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, carcinoma in situ of the cervix, etc.);
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: sac-TMT, SKB264, MK-2870fixed dosage 4mg/kg iv, D1, D15, each 4 weeks one cycle. Drug reduction will be implemented according to the research plan. | Drug | sac-TMT + Furmonertinib |
| Furmonertinib160mg QD or 80mg QD, each 4 weeks one cycle, according to the safety run-in phase, until confirmed by the investigator as imaging disease progression, intolerable toxicity, subject's request to terrminate treatment, or other treatment termination criteria specified in the protocol. Drug reduction will be implemented according to the research plan. | Drug | sac-TMT + Furmonertinib |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to approximately 12 months
Objective Response Rate (ORR) assessed according to the evaluation criteria for the efficacy of RECIST v1.1
4 secondary outcomes
Progression Free Survival (PFS)
Time frame: From treatment administration up to a maximum duration of 12 months.
Duration of Response (DoR)
Time frame: Through study completion, an expected average of 12 months.
Disease Control Rate (DCR)
Time frame: From treatment administration up to a maximum duration of 12 months.
Overall Survival (OS)
Time frame: From treatment administration up to a maximum duration of 12 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 25 Sep 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab Tirumotecan and Furmonertinib in people with NSCLC (Non-small Cell Lung Cancer), run by Fudan University.
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 3 inclusion and 1 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 25 Sep 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 Jialei Wang Ph.D (18017312369, wangjialei@shca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to approximately 12 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 25 Sep 2025.