New drug cocktail aims to tackle resistant lung cancer
NCT ID NCT07193160
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial tests a combination of two drugs—sacituzumab tirumotecan and furmonertinib—in 45 people with advanced EGFR-mutant non-small cell lung cancer whose first targeted therapy stopped working. The study measures how many patients respond to treatment and how long the benefit lasts. It is a single-arm, open-label trial, meaning everyone gets the same treatment and there is no placebo group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sacituzumab tirumotecan (a drug that targets cancer cells) and furmonertinib (a targeted therapy pill)
- What this could lead to
- If this combination works, it could offer a new second-line treatment option for people with a specific type of advanced lung cancer whose first treatment stopped working.
- What could go wrong
- This is a small, early-phase (Phase II) trial with only 45 people and no comparison group, so results may not apply broadly. The drug combination may cause side effects or not improve outcomes significantly.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2025
An estimate. Start dates often move.
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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: 1. No brain metastasis; 2. 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; Exclusion Criteria: * 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.);
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a guided missile for chemo hit tumors harder and spare healthy tissue?
- Can a Triple-Drug combo before surgery eliminate EGFR-Mutant lung cancer?
- Can a targeted pill after surgery keep early lung cancer from returning?
- Can a new immune drug outsmart Hard-to-Treat tumors?
- Can a pill plus immunotherapy and targeted radiation shrink lung tumors before surgery?
- Can a targeted drug combo boost chemoradiation in EGFR-Positive lung cancer?