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Small-cell Lung CancerPhase 2NCT05957510

Safety and Efficacy Evaluation of Serplulimab Plus Chemo in SCLC Transformed From EGFR-mutated NSCLC After Treatment

A Phase 2 study testing Serplulimab and SOC in people with Small-cell Lung Cancer, run by Guangdong Association of Clinical Trials at 1 site 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

This investigator-initiated, open-label, prospective Phase II clinical trial, planned to take place across multiple centers in China. We design this trial to evaluate the safety and efficacy of Serplulimab plus chemotherapy in SCLC transformed from EGFR-mutated NSCLC after treatment. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Small-cell Lung Cancer
What is being tested?
Serplulimab and SOC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteChina
Study dates
7 Jul 2023to 31 Dec 2026
Phase
Phase 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Volunteer to participate in clinical studies.
  • Age 18-75 (including the cut-off value) when signing the Informed Consent Form (ICF)
  • Patients must provide pathological diagnosis reports and genetic testing reports before transformation, and the reports clearly indicate that they were non-small cell lung cancer containing EGFR mutations before transformation.
  • Patients must provide a pathological diagnosis report after transformation, as well as 10 unstained reports after transformation. The pathology of the patients after transformation was SCLC or high-grade neuroendocrine carcinoma or containing SCLC components.
  • Patients who have not received systemic therapy and anti-PD-1/L1 and CTLA-4 therapy after tissue type transformation. Patients are allowed to receive immunotherapy before transformation, but the last line of therapy cannot contain immunotherapy.
  • The end of previous anti-tumor treatment must be more than 2 weeks from the first medication in this study, and the treatment-related AE should be recovered to CTCAE 5.0 ≤ grade 1 (except for grade 2 alopecia).
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  • At least one measurable target lesion based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria identified within the four weeks leading up to the initial treatment dose
  • ECOG PS 0 or 1
  • Expected life expectancy of 12 weeks or more
  • Adequate organ function
  • The serum pregnancy test of female patients must be negative within 14 days before treatment, and effective contraceptive measures should be taken during treatment and within 6 months after treatment. Lactation is prohibited during treatment.
  • Male patients must agree to abstinence (avoid heterosexual intercourse) or take contraceptive measures.

Who cannot join

  • Patients cannot provide a pathology report after tissue type transformation.
  • Patients with a known history of severe allergies to any monoclonal antibody ( NCI-CTCAE 5.0 grade greater than grade 3 ); or known hypersensitivity to carboplatin/etoposide components.
  • Patients with known or screening findings of active central nervous system (CNS) metastases and/or cancerous meningitis (Exceptions will be made for patients with asymptomatic brain metastases or those who have had stable brain metastases for at least 4 weeks after treatment)
  • Patients who have received systemic therapy or other immune checkpoint inhibitors after tissue type transformation; patients who are preparing for or have previously received organ or bone marrow transplantation.
  • Any active infection requiring systemic anti-infectious therapy within 14 days before the first administration.
  • Myocardial infarction or poorly controlled arrhythmia has occurred within 6 months before the first administration; or according to the NYHA standard III-IV cardiac insufficiency or echocardiography left ventricular ejection fraction < 50 %; or pleural effusion, pericardial effusion or ascites requiring clinical intervention.
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  • Patients have uncontrolled or symptomatic hypercalcemia; Patients have poor blood pressure control; patients with deep vein thrombosis, being treated with anticoagulant or platelet therapy, or previous deep vein thrombosis or severe bleeding caused by the use of anti-angiogenic drugs; Patients with known active or suspected autoimmune diseases (Patients in a stable state who do not require systemic immunosuppressive therapy are allowed to be enrolled).
  • Patients who have been and were screened and judged by the investigator to be likely to interfere with the detection and management of suspected drug-related lung toxicity; Patients who the investigator believes have any factors that are inappropriate for participating in this trial.
  • Patients with hepatitis B; or hepatitis C patients; or syphilis screening positive; or known human immunodeficiency virus ( HIV ) positive history or HIV screening positive; known history of mental drug abuse or drug abuse.
  • Other active malignancies tumors within 5 years or concurrently.
  • Patients who were vaccinated with live or attenuated vaccines within 28 days before the first dose, or had plans to vaccinate such vaccines during the study period (but inactivated virus vaccines for seasonal influenza are allowed) or who underwent major surgery.
  • Patients with spinal cord compression who have not been radically cured by surgery and/or radiotherapy. Received radical radiotherapy within 3 months before the first administration.
  • Patients who were participating in other clinical studies, or who participated in any other clinical trials (including drugs and devices, etc.) and received intervention within 3 months or 5 half-lives (whichever is longer) before screening.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Guangdong Provincial Perople's Hospital

    Guangzhou, Guangdong

Other trials in China

About this study

Official title: Evaluation of Safety and Efficacy of Serplulimab Plus Chemotherapy in Patients With Histological Transformation From EGFR-mutated NSCLC to SCLC After Treatment: a Single-arm, Multicenter, Open-label Phase II Study

This investigator-initiated, open-label, prospective Phase II clinical trial, planned to take place across multiple centers in China. We design this trial to evaluate the safety and efficacy of Serplulimab plus chemotherapy in SCLC transformed from EGFR-mutated NSCLC after treatment.

Read the detailed description

Participants with EGFR-mutant NSCLC who were transformed into SCLC after treatment and did not undergo systemic anticancer therapy after transformation will be divided into three cohorts. We plan to enroll 36 patients in the first cohort, and 18 patients in the second cohort. Participants in cohort 1 and cohort 2 will undertake a combination chemotherapy regimen, comprised of serplulimab (300mg), etoposide (100 mg/m2), and carboplatin (AUC 5 mg/mL/min, up to 750mg). These agents will be administered intravenously in 3-week intervals over a span of 4 to 6 cycles. Participants in cohort 3 will be treated with the clinical routine treatment recommended by the investigator.

Being tested
Serplulimab, SOC
Keywords
transformed SCLC, EGFR-mutated NSCLC
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.

  • SerplulimabDrug

    Also called etoposide, carboplatin

    serplulimab 300mg, d1, q3w, iv. etoposide 100 mg/m2, d1-3, q3w, iv. carboplatin AUC 5 (up to 750mg), d1, q3w, iv.

  • SOCDrug

    the treatment recommended by the investigator

Study groups in NCT05957510
Study groupRoleWhat they receive
Cohort 1ExperimentalPatients who met the inclusion criteria, did not meet the exclusion criteria, and agreed to accept the treatment plan of this study will undertake a combination chemotherapy regimen, comprised of serplulimab (300mg), etoposide (100 mg/m2), and carboplatin (AUC 5 mg/mL/min, up to 750mg). These agents will be administered intravenously in 3-week intervals over a span of 4 to 6 cycles.
Receives: Drug: Serplulimab
Cohort 2ExperimentalPatients who met the specific inclusion criteria, did not meet the specific exclusion criteria, and agreed to accept the treatment of this study will undertake the same treatment as cohort 1 in the form of ' compassionate use '.
Receives: Drug: Serplulimab
Cohort 3ExperimentalPatients with treatment contraindications or unwillingness to accept the treatment of this study will be treated with the clinical routine treatment recommended by the investigator.
Receives: Drug: SOC

What is being measured

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

  1. Progression free survival (PFS)

    PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1).

    Measured: From date of first dosing to first documented progression or death from any cause, whichever came first, assessed up to 2 years.

Secondary outcomes (2)

  1. Objective Response Rate

    Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.

    Measured: Up to 2 years

  2. Overall survival (OS)

    OS is the time from the date of first dosing date to death due to any cause.

    Measured: Up to approximately 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 posted24 Jul 2023
  2. Study start7 Jul 2023
  3. Primary completion2 Jul 2026
  4. Study completion31 Dec 2026 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05957510
Sponsor's protocol ID
CTONG2302 (HLX10IIT39)
Status last verified
Jul 2026
First submitted
5 Jul 2023
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Huang J, Zhang XH, Cai Y, Yang D, Shi J, Xing P, Xu T, Wu L, Su W, Xu R, Wei T, Chen HJ, Yang JJ. Rationale and Design of a Phase II Trial of Combined Serplulimab and Chemotherapy in Patients with Histologically Transformed Small Cell Lung Cancer: a Prospective, Single-arm and Multicentre Study. Clin Oncol (R Coll Radiol). 2024 Jan;36(1):39-45. doi: 10.1016/j.clon.2023.11.030. Epub 2023 Nov 11.

    PubMed 37977903

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Serplulimab and SOC in people with Small-cell Lung Cancer, run by Guangdong Association of Clinical Trials at 1 site 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 12 inclusion and 13 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 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 phase mean?

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?

Progression free survival (PFS) (time frame: From date of first dosing to first documented progression or death from any cause, whichever came first, assessed up to 2 years.). 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 NCT05957510, which also lists 1 linked publication.

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 28 Jul 2026.

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