Lung CarcinomaPhase 2NCT07019675
A Study of SKB518 in Patients With Lung Cancer
A Phase 2 study testing SKB518, Tislelizumab and Carboplatin in people with Lung Carcinoma, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 17 sites in China.
Trial summary
This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB518 in patients with lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Carcinoma
- What is being tested?
- SKB518, Tislelizumab and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 17 sitesChina
- Study dates
- 29 Aug 2025to 20 Oct 2027
- 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
- Age between 18 and 75 years old at the time of signing the informed consent form, applicable to both males and females.
- Non-small cell lung cancer (NSCLC) or small cell lung cancer(SCLC) confirmed by histology or cytology.
- At least one measurable tumor lesion per RECIST v1.1.
- Performance status score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
- Expected survival period ≥ 12 weeks.
- The function of important organs meets the requirements of the protocol.
Who cannot join
- Symptomatic or uncontrolled cardiovascular disease
- History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD;
- Subjects with the disease that requires systemic corticosteroid therapy (prednisolone or equivalent dose of similar drugs at a dose of >10 mg/d) or other immunosuppressive therapy within 14 days before the first dose.
- Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
- The Investigator considers other situations that will interfere with the evaluation of the study intervention or the safety of the subjects or the interpretation of the results of the study.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
China17 sites, 17 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Science
Beijing
Jie Wang, zlhuxi@163.com
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan
Hui Wang
Bolin Chen
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Yun Fan
- Recruiting
Cancer Hospital of Shandong First Medical University
Jinan, Shandong
Xiangjiao Meng
- Recruiting
Yunnan Cancer Hospital
Kunming, Yunnan
Runxiang Yang
- Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi
Hui Luo
- Recruiting
Cancer Hospital of Guangxi Medical University
Nanning, Guangxi
Wenhua Zhao
- Recruiting
Shanghai Pulmonary Hospital (Affiliated to Tongji University)
Shanghai
Yayi He
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, Guangdong
Shi Jin
- Recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi
Qinxiang Guo
- Recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang
Dongqing Lv
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Peng Chen
- Recruiting
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Chunlin Liu
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei
Bin Yang
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei
Qibin Song
- Recruiting
Xiangyang Central Hospital
Xiangyang, Hubei
Tienan Yi
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Sanxing Guo
About this study
Official title: A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of SKB518 in Patients With Lung Cancer
This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB518 in patients with lung cancer. Eligible subjects will receive SKB518 monotherapy, until radiographic disease progression, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
- Conditions
- Lung Carcinoma
- Being tested
- SKB518, Tislelizumab, Carboplatin
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKB518Drug
SKB518 is administered every 3 weeks(Q3W) until radiographic disease progression, intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
TislelizumabDrug
Also called Tevimbra
Tislelizumab is administered every 3 weeks(200 mg, Q3W) until radiographic disease progression, intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
CarboplatinDrug
Carboplatin is administered at every 3 weeks(AUC 5 mg/mL/min, Q3W) for 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| 2L+ SCLC or non-Squamous NSCLC | Experimental | SKB518 monotherapy Receives: Drug: SKB518 |
| 2L SCLC | Experimental | SKB518+Tislelizumab or Tislelizumab monotherapy Receives: Drug: SKB518; Drug: Tislelizumab |
| 1L ES-SCLC | Experimental | SKB518+Tislelizumab+Carboplatin Receives: Drug: SKB518; Drug: Tislelizumab; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE
Incidence and severity of Adverse Events (AEs)
Measured: Up to 24 months
ORR in specific arms
Objective Response Rate (ORR) assessed by the investigators per RECIST v1.1
Measured: Up to 24 months
PFS in specific arm
Progression-Free Survival (PFS) assessed by the investigators per RECIST v1.1
Measured: Up to 24 months
Secondary outcomes (5)
PFS in specific arms
Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.
Measured: Up to 24 months
DOR in specific arms
Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.
Measured: Up to 24 months
OS
Time from start of treatment to death due to any reason.
Measured: Up to 24 months
Pharmacokinetics
Maximum and minimum drug concentrations (Cmax and Cmin) of SKB518-ADC and SKB518-TAb (antibody-drug conjugate and total antibody forms of SKB518) in Serum; Cmax and Cmin of SKB518-Free Payload in Plasma
Measured: Up to 24 months
Immunogenicity
Anti-Drug Antibody(ADA) Titre of SKB518
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start29 Aug 2025
- Primary completion20 Feb 2027 (estimated)
- Study completion20 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019675
- Sponsor's protocol ID
- SKB518-II-02
- Status last verified
- May 2026
- First submitted
- 5 Jun 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of SKB518 in Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT07019675
- Acronym / sponsor ID
- SKB518-II-02
- Conditions
- Lung Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Aug 2025 (actual)
- Primary completion
- 20 Feb 2027 (estimated)
- Study completion
- 20 Oct 2027 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB518 in patients with lung cancer. Eligible subjects will receive SKB518 monotherapy, until radiographic disease progression, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2L+ SCLC or non-Squamous NSCLC | Experimental | Drug: SKB518SKB518 monotherapy |
| 2L SCLC | Experimental | Drug: SKB518, Drug: TislelizumabSKB518+Tislelizumab or Tislelizumab monotherapy |
| 1L ES-SCLC | Experimental | Drug: SKB518, Drug: Tislelizumab, Drug: CarboplatinSKB518+Tislelizumab+Carboplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 75 years old at the time of signing the informed consent form, applicable to both males and females.
- Non-small cell lung cancer (NSCLC) or small cell lung cancer(SCLC) confirmed by histology or cytology.
- At least one measurable tumor lesion per RECIST v1.1.
- Performance status score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
- Expected survival period ≥ 12 weeks.
Key exclusion criteria (5 listed)
- Symptomatic or uncontrolled cardiovascular disease
- History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD;
- Subjects with the disease that requires systemic corticosteroid therapy (prednisolone or equivalent dose of similar drugs at a dose of >10 mg/d) or other immunosuppressive therapy within 14 days before the first dose.
- Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
- The Investigator considers other situations that will interfere with the evaluation of the study intervention or the safety of the subjects or the interpretation of the results of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SKB518SKB518 is administered every 3 weeks(Q3W) until radiographic disease progression, intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first. | Drug | 1L ES-SCLC, 2L SCLC, 2L+ SCLC or non-Squamous NSCLC |
| TislelizumabAlso: TevimbraTislelizumab is administered every 3 weeks(200 mg, Q3W) until radiographic disease progression, intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first. | Drug | 1L ES-SCLC, 2L SCLC |
| CarboplatinCarboplatin is administered at every 3 weeks(AUC 5 mg/mL/min, Q3W) for 4 cycles | Drug | 1L ES-SCLC |
Primary outcome
AE
Time frame: Up to 24 months
Incidence and severity of Adverse Events (AEs)
ORR in specific arms
Time frame: Up to 24 months
Objective Response Rate (ORR) assessed by the investigators per RECIST v1.1
PFS in specific arm
Time frame: Up to 24 months
Progression-Free Survival (PFS) assessed by the investigators per RECIST v1.1
5 secondary outcomes
PFS in specific arms
Time frame: Up to 24 months
DOR in specific arms
Time frame: Up to 24 months
OS
Time frame: Up to 24 months
Pharmacokinetics
Time frame: Up to 24 months
Immunogenicity
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SKB518, Tislelizumab and Carboplatin in people with Lung Carcinoma, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 17 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 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?
Contact Xin Li (086-010-58202512, lixin@kelun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE (time frame: Up to 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2026.