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New hope for tough lung cancer: drug combo targets tumors after first treatment fails

NCT ID NCT07388875

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a combination of two drugs, sacituzumab tirumotecan and anlotinib, in 30 people with extensive-stage small cell lung cancer whose disease got worse after initial chemotherapy plus immunotherapy. The goal is to see if the combo can shrink tumors or slow cancer growth. Participants will receive the drugs and be monitored for side effects and outcomes.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥18 years at the time of signing informed consent; male or female. * Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC). * Disease progression after receiving only one prior line of therapy consisting of a PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy. * At least one measurable target lesion per RECIST v1.1 as assessed by the investigator, which has not been previously irradiated. * Patients with asymptomatic brain metastases, or patients with treated brain metastases and stable symptoms for ≥4 weeks, are eligible. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Estimated life expectancy of at least 12 weeks. * Adequate organ and bone marrow function (no blood transfusion, recombinant human thrombopoietin, or colony-stimulating factors within 2 weeks prior to first dose), defined as follows: * Hematologic function: * Absolute neutrophil count ≥1.5 × 10⁹/L * Platelet count ≥100 × 10⁹/L * Hemoglobin ≥90 g/L * Hepatic function: * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN; for patients with liver metastases, AST and ALT ≤5 × ULN * Albumin ≥30 g/L * Total bilirubin ≤1.5 × ULN * Renal function: * Creatinine clearance ≥50 mL/min, calculated using the Cockcroft-Gault formula * Coagulation function: * International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) ≤1.5 × ULN * Women of childbearing potential and men with partners of childbearing potential must agree to use effective medical contraception from signing informed consent until 6 months after the last dose of study treatment. * Subjects must voluntarily participate in the study, provide written informed consent, and be able to comply with protocol-required visits and study procedures. Exclusion Criteria: * Participation in another interventional drug clinical trial within 4 weeks prior to enrollment. * Tumors with a high risk of massive hemoptysis, as judged by the investigator. * Prior systemic anti-tumor therapy with anti-angiogenic agents. * Prior treatment with TROP2-targeted therapies and/or topoisomerase I inhibitors. * History of other malignancies within the past 5 years, except for adequately treated cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin. * Known hypersensitivity or allergy to any investigational product or its components. * Known positive human immunodeficiency virus (HIV) infection, history of acquired immunodeficiency syndrome (AIDS), or known active syphilis infection. * History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. * Receipt of live vaccines within 30 days prior to the first dose of study treatment. * History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment; current ILD or non-infectious pneumonitis; or suspected ILD or non-infectious pneumonitis that cannot be excluded by imaging at screening. Severe pulmonary impairment due to pulmonary comorbidities, including but not limited to: * Pulmonary embolism within 3 months prior to first dose * Severe asthma * Severe chronic obstructive pulmonary disease * Restrictive lung disease * Pleural effusion * Autoimmune, connective tissue, or inflammatory diseases involving the lungs (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis) * Prior pneumonectomy * Active autoimmune disease requiring systemic treatment within the past 2 years (hormone replacement therapy is not considered systemic treatment, such as type 1 diabetes mellitus, hypothyroidism requiring only thyroid hormone replacement, or adrenal or pituitary insufficiency requiring physiologic doses of corticosteroids). * Active infection requiring systemic therapy within 2 weeks prior to the first dose of study treatment. * Serious concomitant diseases that, in the investigator's judgment, may compromise patient safety or interfere with completion of the study, including but not limited to uncontrolled hypertension, severe diabetes mellitus, or active infection. * Documented severe dry eye syndrome, severe meibomian gland dysfunction and/or blepharitis, or a history of corneal disorders that may interfere with delayed corneal healing. * Pregnant or breastfeeding women; women of childbearing potential with a positive baseline pregnancy test; or women of childbearing potential who are unwilling to use effective contraception during study treatment and for 6 months after the last dose of study treatment. * Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in the study.

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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

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  1. 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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