New combo therapy targets hard-to-treat lung cancer

NCT ID NCT06217757

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 new treatment for people with a specific type of advanced small cell lung cancer (SLFN-11 positive). The treatment combines low-dose radiation, chemotherapy, an immunotherapy drug (sugemalimab), and a targeted drug (olaparib). The goal is to see if this combination is safe and works better than standard care. About 45 adults who have not had prior treatment for their extensive-stage cancer will take part.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 45 people

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

Started

Apr 2024

Expected to finish

Oct 2028

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. Men or women aged more than or equal to (≥) 18 years old and less than or equal to (≤) 75 years old 2. Histologically or cytologically confirmed ES-SCLC 3. No prior treatment for ES-SCLC 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5. Five white slides (unstained paraffin sections) were available for immunohistochemical SLFN-11 detection and SLFN-11 was positive 6. Extensive clinical stage. American Joint Committee on Cancer (AJCC) 8th edition Stage IV with lesions exceeding one side of the chest and including malignant pleural and pericardial effusions or hematogenous metastases (any T, any N, M1a/b/c); or T3-4 due to multiple nodules in the lung or tumor/nodule size too large to be included in a T3-4 disease within a tolerable radiotherapy schedule 7. The subjects were considered suitable for combining etoposide with cisplatin chemotherapy and low-dose radiotherapy as first-line treatment for extensive -stage small cell lung cancer 8. Have measurable lesions as defined by RECIST1.1, with at least one lesion (never previously treated with radiation) of ≥10 mm longest diameter accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) at baseline (except for lymph nodes, which must have a short axis of ≥15 mm) and the lesion is suitable for repeat and accurate measurements 9. Patients with brain metastases must be asymptomatic or stable on steroids and anticonvulsants for at least 1 month prior to study treatment. Participants with suspected brain metastases during screening should have a CT/MRI of the brain prior to study 10. No previous treatment with immune checkpoint inhibitors and PARP inhibitors, including but not limited to other anti-PD-1, anti-PD-L1 and anti-programmed cell death ligand 2 (anti-PD-L2) antibodies, with the exception of therapeutic anti-tumor vaccines. No prior chemotherapy or radiation therapy to the chest lesion 11. Weight over 30 Kg 12. Life expectancy ≥ 12 weeks 13. Have adequate organ and bone marrow functional reserve and normal major organ function 14. Patients were compliant, voluntarily enrolled in the study and signed an informed consent form 15. For women or men with childbearing potential: use effective contraception to avoid conception or embryonic drug exposure during treatment and for 5 months after the last dose of sugemalimab and for 6 months after the last dose of cisplatin or etoposide. Female subjects are prohibited from donating eggs during this period and males are prohibited from donating sperm during this period Exclusion Criteria: 1. Histopathologic or cytopathologic diagnosis of mixed small cell lung cancer or non-small cell lung cancer 2. Limited stage small cell lung cancer 3. Combination of poorly controlled malignant pleural or pericardial effusions requiring continuous drainage 4. Presence of active or symptomatic brain metastases or Leptomeningeal metastases 5. Prior systemic antitumor therapy (chemotherapy, targeted agents such as PARP inhibitors) or immune checkpoint inhibitors for SCLC 6. Presence of active, unstable systemic disease such as active infection, autoimmune disease, inflammatory disease (uncontrolled hypertension, heart failure (NYHA classification \>= Class II), unstable angina, acute coronary syndrome, severe arrhythmia, severe hepatic, renal or metabolic disease, human immunodeficiency virus (HIV) immunodeficiency virus (HIV) infected patients 7. Previous allogeneic stem cell or solid organ transplantation 8. Patients with prior interstitial lung disease, drug-induced interstitial lung disease, or active interstitial pneumonia requiring systemic glucocorticoid or immunosuppressive therapy; Patients with pulmonary interstitial fibrosis or active pulmonary tuberculosis 9. Severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia 10. Received therapeutic oral or intravenous infusion of antibiotics within 2 weeks prior to the start of study treatment 11. Been diagnosed or treated for another malignancy (excluding resected basal cell carcinoma of the skin or other carcinoma in situ) within 5 years prior to randomization to this study 12. For pregnant or lactating females or male or female subjects of reproductive potential who refuse to use effective contraception during treatment and within 5 months of the last dose of sugemalimab and within 6 months of the last dose of cisplatin or etoposide 13. Allergic to the study drug or its components 14. The investigator believes that the patients may not be able to complete the study or comply with the requirements of the study 15. Inadequate bone marrow function and vital organ function reserve 16. Concurrent participation in another clinical study, unless it is an observational (non-interventional) clinical study or a follow-up phase of an interventional study, excluding patients who have received any other experimental drug within 28 days prior to the start of study treatment 17. Patients who are not suitable for etoposide-cisplatin chemotherapy, sugemalimab or olaparib 18. History of thoracic radiotherapy or plan to receive intensive thoracic radiotherapy prior to systemic therapy. External chest radiotherapy for palliative purposes (e.g., bone metastases) is allowed, but must be completed prior to the first administration of study drug

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610044, China

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