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SCLC, Extensive StagePhase 1/2NCT06477523

Phase 1b/2 Study of LDRT in Combination With AK104 Plus Chemotherapy as First-line Treatment for ES-SCLC

A Phase 1/2 study testing AK104, Etoposide and Carboplatin in people with SCLC, Extensive Stage, run by Sichuan University at 2 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Phase Ib/II, open-label, multicentre study to evaluate the efficacy and safety of low-dose radiotherapy (LDRT) combined with AK104 and chemotherapy as first-line treatment for patients with ES-SCLC. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
SCLC, Extensive Stage
What is being tested?
AK104, Etoposide and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
2 sitesChina
Study dates
16 May 2024to 31 Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 to 80 years old.
  • Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
  • Histologically or cytologically confirmed diagnosis of ES-SCLC per the Veterans Administration Lung Study Group (VALG) staging system.
  • No prior treatment for ES-SCLC.
  • Measurable disease, as defined by RECIST v1.1.
  • Eastern Cooperative Oncology Group performance status ≤ 1.
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  • Life expectancy ≥ 3 months.
  • Adequate hematologic and end-organ function.
  • All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.

Who cannot join

  • Symptomatic or actively progressing Central nervous system metastases.
  • Uncontrolled carcinomatous meningitis.
  • Uncontrolled severe cancer pain
  • Uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures (once a month or more frequently).
  • Uncontrolled or symptomatic hypercalcemia.
  • History of autoimmune disease.
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  • History of idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on chest computed tomography (CT) during screening.
  • Active Tuberculosis infection.
  • Significant cardiovascular disease.
  • Major surgical procedure within 28 days prior to enrollment or anticipation of need for major surgical procedure during the course of the study.
  • Known additional malignancy that is progressing or requires active treatment.
  • Active infection requiring systemic therapy
  • Prior allogenic bone marrow transplantation or solid organ transplant.
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk for treatment complications.
  • Receipt of live attenuated vaccination within 4 weeks prior to the first dose of study treatment, or plan to receive live attenuated vaccine during the study.
  • Currently receiving the treatment of hepatitis B virus infection..
  • Received approved or under development systematic anti-tumor therapy within 28 days before enrollment
  • Previously received immune checkpoint agonists (antibodies to CD137 targets) or immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.) , immune cell therapy and other treatment of any immune mechanism for tumors
  • Treatment with systemic immunosuppressive medications within 1 week prior to enrollment..
  • Known allergies or intolerant to test drugs or their excipients; or a known history of severe hypersensitivity reactions to other antibodies.
  • Women who are pregnant (positive pregnancy test before medication) or breastfeeding.
  • Received chest radiation therapy prior to the first dose.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • China West Hospital

    Chengdu, Sichuan, 610000

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: Phase 1b/2 Study of AK104 (Anti-PD1/CTLA4 Bispecific Antibody) in Combination With Etoposide and Carboplatin Plus Low-dose Radiotherapy (LDRT) for the First-line Treatment of Patients With Extensive Stage Small Cell Lung Cancer

Phase Ib/II, open-label, multicentre study to evaluate the efficacy and safety of low-dose radiotherapy (LDRT) combined with AK104 and chemotherapy as first-line treatment for patients with ES-SCLC.

Read the detailed description

This trial aims to assess the safety and efficacy of a new therapeutic strategy that combines to low-dose radiotherapy combination With AK104 plus etoposide and carboplatin/cisplatin.

Being tested
AK104, Etoposide, Carboplatin, low-dose radiotherapy

What participants receive

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

  • AK104Drug

    Also called Cadonilimab

    IV infusion

  • EtoposideDrug

    Also called Chemotherapy

    Etoposide intravenous infusion was administered at a dose of 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle during the induction phase (Cycles 1-4).

  • CarboplatinDrug

    Also called Chemotherapy

    Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).

  • low-dose radiotherapyRadiation

    Also called LDRT

    The subjects will receive LDRT, from C1D1-C1D5, once a day for 3Gy, until the target dose of 15Gy is achieved (Cycles 1).

    LDRT treatment for primary/mediastinal positive lymph nodes/metastatic lesions during maintenance therapy (C1D1-C1D5, 15Gy).

Study groups in NCT06477523
Study groupRoleWhat they receive
LDRT+AK104+chemotherapyExperimentalAK104(IV, D1) + Cisplatin (IV, D1)/Carboplatin (IV, D1) +Etoposide (IV, D1-D3) were administrated on a 21-day cycle for four cycles. Concurrent LDRT (15 Gy/5f) were conducted from D1-D5 in the first cycle. Then pts received LDRT and AK104 maintenance until loss of clinical benefit or unacceptable toxicity.
Receives: Drug: AK104; Drug: Etoposide; Drug: Carboplatin; Radiation: low-dose radiotherapy

What is being measured

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

  1. Incidence of treatment-related adverse events

    The incidence of treatment-related adverse events were measured for determining tolerability and safety. Adverse events (AEs) are evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). Events of grade 3-5 are defined as moderate and severe adverse events.

    Measured: 48 months

  2. Progression free survival at 6 months (PFS-6)

    PFS-6 is defined as patient outcomes were evaluated at diagnosis and in the subsets of patients achieving progression-free status at 6 months from diagnosis.

    Measured: 6 months

Secondary outcomes (8)

  1. Disease control rate (DCR)

    DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST V1.1

    Measured: Interval between the date of enrollment and the date of death due to any cause , up to a maximum of approximately 2 years

  2. Progression free survival (PFS)

    PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1) assessed by the investigator or death due to any cause (whichever occurs first)

    Measured: Interval between the date of enrollment and the date of progressive disease, or death due to any cause (whichever occurs first), up to a maximum of 24 months.

  3. PFS Rates at 12 months (PFS-12)

    PFS-6 is defined as patient outcomes were evaluated at diagnosis and in the subsets of patients achieving progression-free status at 12 months from diagnosis.

    Measured: 12 months.

  4. Overall survival (OS)

    OS is defined as the time from randomization to death.

    Measured: Interval between the date of enrollment and the date of progressive disease, or death due to any cause (whichever occurs first), up to a maximum of 24 months.

  5. OS Rates at 12 Months (OS-12)

    OS-12 is defined as patient outcomes were evaluated at diagnosis and in the subsets of patients survival at 12 months from diagnosis.

    Measured: 12 months

  6. OS Rates at 24 Months ( OS-24)

    OS-24 is defined as patient outcomes were evaluated at diagnosis and in the subsets of patients survival at 24 months from diagnosis.

    Measured: 24 months

  7. Objective Response Rate (ORR)

    ORR is proportion of subjects with complete response(CR) or partial response(PR). Tumor responses will be evaluated according to RECIST 1.1 criteria. Patients with no tumor assessment after baseline will be classified as non-responders.

    Measured: Interval between the date of enrollment and the date of death from any cause, up to a maximum of 18 months.

  8. Number of participants with adverse events (AEs)

    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product.

    temporally associated with the use of study treatment, whether or not considered related to the study treatment

    Measured: From the subject signs the Informed Consent Form to 90 days after the last dose of study treatment or initiation of other anti-tumor therapy

Timeline

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

  1. First posted27 Jun 2024
  2. Study start16 May 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06477523
Sponsor's protocol ID
AK104-IIT-027
Status last verified
Apr 2026
First submitted
19 Jun 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 1/2 study testing AK104, Etoposide and Carboplatin in people with SCLC, Extensive Stage, run by Sichuan University at 2 sites in China.

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 22 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: under way, not looking for participants, 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.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Incidence of treatment-related adverse events (time frame: 48 months). The study lists 2 primary outcomes in all. 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 NCT06477523.

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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