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Extensive-stage Small-cell Lung CancerPhase 1NCT06732258

Low-dose Radiotherapy Combined With Concurrent Chemotherapy, Toripalimab and Tifcemalimab in the Treatment of ES-SCLC

A Phase 1 study testing Low-dose radiotherapy, Tifcemalimab injection and Toripalimab in people with Extensive-stage Small-cell Lung Cancer, run by Sichuan University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

To evaluate the tolerability and safety of Low-dose radiotherapy combined with concurrent Chemotherapy, Toripalimab and Tifcemalimab in first-line treatment of Extensive-Stage Small Cell Lung Cancer, and to determine the RP2D. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Extensive-stage Small-cell Lung Cancer
What is being tested?
Low-dose radiotherapy, Tifcemalimab injection and Toripalimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
10 Jan 2025to 29 Feb 2028
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years, male or female;
  • Histologically or cytologically confirmed extensive stage small cell lung cancer;
  • Previously untreated extensive stage small cell lung cancer;
  • ECOG PS 0-1;
  • Measurable lesions according to RECIST 1.1, and measurable lesions can only be included in previously irradiated lesions if the lesion shows definite disease progression after radiotherapy;
  • Expected survival ≥ 3 months;
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  • Normal function of major organs, that is, meet the following criteria: neutrophils ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, hemoglobin ≥ 90 g/L; serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min; serum total bilirubin ≤ 1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; ALT and AST ≤ 5 × ULN in patients with liver metastases; international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN unless the subject is receiving anticoagulant therapy, activated partial thrombin time (aPTT) ≤ 1.5 × ULN unless the subject is receiving anticoagulant therapy;
  • Female subjects of childbearing potential, as well as male subjects with partners of childbearing potential, need to use a medically recognized contraceptive (such as an intrauterine device, contraceptive, or condom containing spermicide) during study treatment and for at least 4 months after the last use of study drug;
  • Voluntary participation in this study, signed informed consent, good compliance, with follow-up.

Who cannot join

  • Mixed SCLC and non-small cell lung cancer (NSCLC);
  • Symptomatic, untreated or progressive central nervous system (CNS) metastases;
  • Received any systemic anti-tumor therapy for ES-SCLC;
  • Previously received any immune checkpoint inhibitors, including but not limited to CTLA-4 inhibitors, PD-1/PD-L1 inhibitors, BTLA inhibitors;
  • Known hypersensitivity to the study drug or excipients, known serious allergic reactions to any monoclonal antibody;
  • Pulmonary artery invasion;
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  • History of leptomeningeal disease;
  • Uncontrollable tumor-related pain;
  • Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
  • Uncontrolled or symptomatic hypercalcemia;
  • Uncontrolled hypertension, history of hypertensive crisis or hypertensive encephalopathy;
  • Patients with active autoimmune diseases, autoimmune diseases or systemic use of steroids/immunosuppressive agents;
  • History of idiopathic pulmonary fibrosis, tissue pneumonia, drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on chest CT scan;
  • Active pulmonary tuberculosis, or patients with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or patients with a history of active pulmonary tuberculosis infection more than 1 year ago but without regular treatment;
  • Known human immunodeficiency virus (HIV) infection, active hepatitis B or C patients; HBsAg positive patients may participate in this study if HBV DNA testing is < 500 IU/ml or if the lower limit of detection at the site. HCV antibody positive patients may participate in this study if HCV RNA detection is less than the lower limit of detection value at the site where they are located;
  • Patients with severe cardiovascular disease, such as New York Heart Association (NYHA) class 2 or higher heart failure, unstable angina pectoris, unstable arrhythmia, myocardial infarction or cerebrovascular accident within 6 months before enrollment;
  • Patients with other malignant tumors (except for non-melanoma skin basal cell carcinoma or squamous cell carcinoma, breast/cervical carcinoma in situ, superficial bladder cancer and other carcinoma in situ who have received radical treatment and have no evidence of disease recurrence) within 5 years before the start of treatment or at the same time;
  • According to the investigator 's judgment, the subject has other factors that may cause the subject to be forced to terminate the study halfway, such as having other serious diseases (including mental illness) requiring concomitant treatment, severely abnormal laboratory test values, and/or family or social factors that may affect the patient' s safety or collection of trial data.

About this study

Official title: Exploratory Clinical Study of Low-dose Radiotherapy Combined With Concurrent Chemotherapy, Toripalimab and Tifcemalimab in First-line Treatment of Extensive-Stage Small Cell Lung Cancer

To evaluate the tolerability and safety of Low-dose radiotherapy combined with concurrent Chemotherapy, Toripalimab and Tifcemalimab in first-line treatment of Extensive-Stage Small Cell Lung Cancer, and to determine the RP2D.

Read the detailed description

This is a single-center, single-arm, exploratory clinical study to evaluate the safety and tolerability of low-dose radiotherapy (LDRT) concurrent chemotherapy combined with toripalimab and Tifcemalimab (JS004) in the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Approximately 6-12 subjects were planned to be enrolled in this clinical study. The study will adopt a "3 + 3" dose escalation design, and the observation period for dose-limiting toxicities (DLTs) is 21 days after the first dose administration. Patients who meet the inclusion criteria will receive toripalimab 240 mg q3w, tifcemalimab 100 mg or 200 mg q3w until disease progression or intolerable toxicity; cisplatin for injection 75 mg/m2 or carboplatin AUC = 5, q3w, etoposide 100 mg/m2, d1, d2, d3, q3w for 4-6 cycles; low-dose radiotherapy with a total dose of 15 Gy, radiotherapy will be started on Cycle 1 Day 1 in 5 divided doses (15 Gy/5F).

Being tested
Low-dose radiotherapy, Tifcemalimab injection, Toripalimab, Cisplatin, Carboplatin
Keywords
ES-SCLC, Toripalimab, Tifcemalimab, LDRT
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-dose radiotherapyRadiation

    The LDRT deals with primary tumour in a 15 Gy of 5 fractions over five days, starting from Day 1 in the first cycle.

  • Tifcemalimab injectionDrug

    100 mg or 200 mg q3w until disease progression or intolerable toxicity;

  • ToripalimabDrug

    240 mg q3w until disease progression or intolerable toxicity;

  • CisplatinDrug

    75 mg/m2 q3w for 4-6 cycles;

  • CarboplatinDrug

    AUC = 5, q3w for 4-6 cycles;

  • EtoposideDrug

    100 mg/m2, d1, d2, d3, q3w for 4-6 cycles;

Study groups in NCT06732258
Study groupRoleWhat they receive
Low-dose radiotherapy concurrent Chemotherapy combined with Toripalimab and TifcemalimabExperimentalNot described
Receives: Radiation: Low-dose radiotherapy; Drug: Tifcemalimab injection; Drug: Toripalimab; Drug: Cisplatin; Drug: Carboplatin; Drug: Etoposide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Dose-limiting Toxicitys (DLTs)

    Measured: up to 21 days after the first dose

Secondary outcomes (5)

  1. Objective response rate (ORR)

    Defined as the proportion of subjects achieving a complete response (CR) or partial response (PR) during treatment.

    Measured: up to 2 years

  2. Disease control rate (DCR)

    Defined as the proportion of subjects achieving complete response (CR) or partial response (PR) or stable disease (SD) during treatment.

    Measured: up to 2 years

  3. Duration of response (DOR)

    Defined as the time from the first documented response (CR or PR) to the first documented disease progression or death, whichever came first.

    Measured: up to 2 years

  4. Progression-free survival (PFS)

    Defined as the time from enrollment to the first documented disease progression or death from any cause, whichever came first.

    Measured: up to 2 years

  5. Overall Survival (OS)

    Defined as the time from enrollment to death due to any cause.

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2024
  2. Study start10 Jan 2025 (estimated)
  3. Primary completion28 Feb 2026 (estimated)
  4. Study completion29 Feb 2028 (estimated)

Why it stopped: Inorder to avoid the serious adverse effect of Toripalimab combining with Tifcemalimab, considering as the protection of participants.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06732258
Sponsor's protocol ID
CONTEST
Status last verified
Apr 2026
First submitted
9 Dec 2024
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Low-dose radiotherapy, Tifcemalimab injection and Toripalimab in people with Extensive-stage Small-cell Lung Cancer, run by Sichuan University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Dose-limiting Toxicitys (DLTs) (time frame: up to 21 days after the first dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06732258.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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