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New cocktail of immunotherapy, targeted drug, chemo, and radiation takes on lung cancer

NCT ID NCT07538258

Disease control Sponsor: Yayi He Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing a powerful combination of treatments for people with limited-stage small cell lung cancer (LS-SCLC) who have not had prior therapy. Participants will receive an immunotherapy drug (benmelstobart), an anti-angiogenic pill (anlotinib), standard chemotherapy (cisplatin or carboplatin plus etoposide), and radiation to the chest. The goal is to see how many tumors shrink or disappear. The study will enroll 27 people and follow them for up to 2 years on maintenance therapy. Because it is a small, single-arm study without a comparison group, results will be preliminary.

What this could mean

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

Active substance
benmelstobart (immunotherapy), anlotinib (anti-angiogenic drug), cisplatin or carboplatin (chemotherapy), etoposide (chemotherapy), and thoracic radiation
What this could lead to
If successful, this combination could improve tumor shrinkage and delay progression in limited-stage small cell lung cancer, potentially offering a more effective first-line treatment option.
What could go wrong
This is a small, early-phase (2) single-arm study with only 27 participants, so results may not be generalizable. Combining multiple therapies increases the risk of serious side effects, and the trial has not yet started recruiting.

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 27 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

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 to 75 years

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: Histologically or cytologically confirmed inoperable limited-stage small cell lung cancer (LS-SCLC) (per VALG staging). 2: No prior systemic therapy for limited-stage small cell lung cancer 3: Presence of measurable lesions as defined by RECIST 1.1. A previously irradiated lesion may be considered measurable only if it has demonstrated clear progression after radiotherapy and is not the sole lesion 4: Age ≥ 18 and ≤ 75 years 5: ECOG performance status: 0-1 6: Expected survival ≥ 3 months 7: Adequate hematologic and organ function, defined as meeting the following criteria: a) Hematologic function (no transfusion of blood or blood products, no G-CSF or other hematopoietic growth factors within 14 days): i. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L (1,500/mm³); ii. Platelet count (PLT) ≥ 100 × 10⁹/L (100,000/mm³); iii. Hemoglobin (HB) ≥ 80 g/L. b) Renal function: i. Calculated creatinine clearance (CrCl) ≥ 50 mL/min; ii. Urine protein \< 2+ or 24-hour urine protein quantification \< 1.0 g. c) Hepatic function: i. Serum total bilirubin (TBil) ≤ 1.5 × ULN; ii. AST and ALT ≤ 2.5 × ULN; iii. Serum albumin (ALB) ≥ 28 g/L. d) Coagulation function: i. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN. e) Cardiac function: i. Left ventricular ejection fraction (LVEF) ≥ 50%. 8: Subjects voluntarily participate in this study, provide written informed consent, demonstrate good compliance, and agree to comply with follow-up procedures. Exclusion Criteria: * 1: Prior use of anti-angiogenic agents such as anlotinib, apatinib, bevacizumab, or related immunotherapeutic agents targeting PD-1, PD-L1, etc 2: Presence of multiple factors affecting oral medication absorption (e.g., inability to swallow, status post gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.). 3: Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 4: Patients with imaging evidence of tumor invasion adjacent to major blood vessels, or judged by the investigator to have a high risk of fatal massive hemorrhage due to tumor invasion of major blood vessels during the subsequent study period. 5: History of severe bleeding tendency or coagulopathy, including but not limited to: clinically significant hemoptysis (more than one tablespoon per day) within 3 months prior to enrollment; or clinically significant bleeding symptoms or bleeding diathesis within 4 weeks prior to randomization, such as gastrointestinal bleeding, hemorrhagic gastric ulcer (including gastrointestinal perforation and/or fistula; however, patients with surgically repaired gastrointestinal perforation or fistula may be eligible), unhealed wounds, ulcers, or fractures, etc. 6: Undergoing major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to randomization. 7: History of arterial/venous thrombotic events within 6 months prior to randomization, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism. 8: Development of active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. 9: Any other conditions that, in the judgment of the investigator, would render the patient ineligible for study enrollment.

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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.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.