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New combo aims to stall aggressive lung cancer

NCT ID NCT07376499

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial tests a four-drug maintenance therapy for people with extensive small cell lung cancer that has responded to initial treatment. The combination includes liposome irinotecan, platinum chemotherapy, an immune checkpoint inhibitor (toripalimab), and an anti-angiogenic drug (anlotinib). The goal is to see if this regimen can delay cancer progression and improve survival. The study plans to enroll 31 participants and is not yet recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Liposome irinotecan, platinum (carboplatin or cisplatin), anlotinib, and toripalimab
What this could lead to
If successful, this combination could offer a new maintenance option to keep extensive small cell lung cancer from progressing longer after initial treatment.
What could go wrong
This is a small, early-phase (phase 2) trial with only 31 people, so results may not apply broadly. The drug combo also carries risks like severe side effects from chemotherapy and immune-related reactions.

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 31 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jun 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: * 1\. Volunteer to join the study, sign the informed consent and sign the date, have good compliance, and cooperate with follow-up 2. Age≥18 years 3. Diagnosis of extensive stage small cell lung cancer (ES-SCLC) confirmed histologically or pathologically (according to American Veterans Lung Cancer Association, VALG staging) 4. ECOG 0-2 5. Subjects had not received any systemic treatment for ES-SCLC in the past (including chemotherapy, use of similar VEGFR inhibitors and immune checkpoint inhibitors, etc.) 6. Subjects with limited-stage small cell lung cancer (LS-SCLC) have received radiotherapy, chemotherapy, or chemoradiotherapy for more than 6 months 7. Expected survival ≥ 3 months 8. Must have measurable target lesions that meet RECIST1.1 criteria (CT scan length of tumor lesion \>10mm); In patients with initial asymptomatic brain metastases, craniocerebral radiotherapy may be performed during induction chemotherapy 9. If the major organs are functioning normally, the following criteria are met: 1. Blood routine examination must meet (no blood transfusion within 14 days, no hematopoietic factor and no drug correction) : ANC ≥ 1.5×10\^9/L; HB ≥ 90 g/L; PLT ≥ 100×10\^9/L 2. Biochemical examination must meet the following criteria: TBIL ≤ 1.5ULN; ALT and AST≤ 2.5ULN; 3. Renal function must meet the following criteria: serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥40 mL/min (using the standard Cockcroft-Gault formula) 4. Coagulation function must meet: INR≤1.5 and APTT≤1.5ULN 10. Female who are fertile must have a serum or urine pregnancy test within 72 hours before the first medication and the result is negative. Fertile female and male subjects whose partners are fertile female must agree to a highly effective method of avoiding and breastfeeding during the study period until 90 days after the last dose of the study drug. The investigator or designee, in consultation with the subject, shall confirm that the subject understands the proper and consistent use of contraceptive methods 11. For males, they should be surgically sterilized or consent to a highly effective method of avoidance during the trial and for 90 days after the last administration of the experimental drug 12. Female participants had to agree not to breastfeed during the study period or for 180 days after the last dose of study treatment Exclusion Criteria: * 1\. Patients with meningeal metastases or symptomatic brain metastases 2. Previous T cell co-stimulation or immune checkpoint therapy, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4)inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, CD137 agonists, or other targeting T cell drugs; 3. Past treatment with anlotinib 4. Factors affecting oral medication, such as inability to swallow, post-GI resection, chronic diarrhea, intestinal obstruction, etc 5. Uncontrollable pleural effusion or ascites 6. Have any active autoimmune disease or history of autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (may be included after hormone replacement therapy), tuberculosis); Patients with skin conditions (such as vitiligo, psoriasis, or alopecia) that have been in complete remission from childhood asthma and do not require any intervention in adulthood and do not require systemic treatment may be included. Patients who require medical intervention with bronchodilators may not be included 7. Patients with congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500IU/ml), hepatitis C (HCV antibody positive and HCV-RNA above the lower detection limit of analytical methods), or co-infection with hepatitis B and hepatitis C 8. Urine routine suggests urinary protein ≥(++), or 24h urinary protein ≥2g or severe hepatic and renal insufficiency 9. Patients requiring systemic therapy with corticosteroids (\>10mg/ day of prednisone or equivalent) or other immunosuppressants within 14 days prior to initial medication. In the absence of active autoimmune disease, inhaled or topical corticosteroids are permitted, as well as adrenal hormone replacement therapy at doses \>10 mg/ day of prednisone efficacy 10. Patients who have been treated with anti-tumor vaccine or other immunostimulating anti-tumor agents (interferon, interleukin, thymosin, immunocell therapy, etc.) within 1 month prior to initial medication 11. Other malignant neoplasms were present within 5 years prior to admission, except for adequately treatable carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery 12. There is evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiological pneumonia, drug-induced pneumonia, radiologically proven active pneumonia, and severe impairment of lung function 13. Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90mmHg, despite optimal medical treatment 14. Patients with grade II or higher myocardial ischemia or myocardial infarction and poorly controlled arrhythmias (including QTc interval * 450ms in men and ≥470ms in women). According to the NYHA criteria, patients with grade III to # cardiac insufficiency, or those with left ventricular ejection fraction (LVEF) \< 50% indicated by color Doppler ultrasound had myocardial infarction in the 6 months prior to enrollment, heart failure of New York Heart Society grade II or above, uncontrolled angina, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, and myocardial infarction. Or electrocardiogram suggests acute ischemia or abnormal active conduction system 15. Concurrent severe infection within 4 weeks prior to first dosing, or unexplained fever \>38.5°C during screening/prior to first dosing 16. Major surgery, open biopsy, or significant trauma were performed within 28 days prior to enrollment 17. Aortic/venous thrombosis occurred within 6 months 18. The researchers assessed possible risk of severe hemoptysis, bleeding events, or wearing 19.Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation 20.Pregnant or lactating women; Fertile patients who are unwilling or unable to use effective contraception 21.Allergic reaction to any investigational drug or its ingredients 22.Any condition that the investigator believes is likely to harm the subject or cause the subject to be unable to meet or perform the study requirements

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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

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