Non-small Cell Lung CancerPhase 2NCT05351788

SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer.

A Phase 2 study testing SKB264, KL-A167 and Carboplatin in people with Non-small Cell Lung Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

The purpose of this study is to assess the safety, tolerability and preliminary antitumor activity of SKB264 in combination with KL-A167 with or without chemotherapy with advanced or metastatic non-small cell lung cancer. The study is divided into two parts. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Non-small Cell Lung Cancer
What is being tested?: SKB264, KL-A167 and Carboplatin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 2 sitesChina
Study dates: 20 May 2022to 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

Males or females ≥ 18 and ≤ 75 years of age at the time of signing the informed consent form;
Histologically and cytologically confirmed NSCLC;
Cohort 1: Patients with locally advanced/metastatic NSCLC with wild-type EGFR and negative ALK fusion gene, no or at most one prior line of systemic chemotherapy regimen for advanced or metastatic NSCLC. Cohort 2: Patients with locally advanced/metastatic NSCLC with wild-type EGFR and negative ALK fusion gene, no prior systemic therapy. Cohort 3: Patients with locally advanced/metastatic NSCLC with EGFR activating mutation and negative ALK fusion gene, who have failed previous treatment with EGFR-TKIs.
Provide fresh or archival tumor tissue for biomarker testing and analysis;
Patients with at least one measurable lesion per RECIST v1.1 criteria, and patients with only skin or bone lesions cannot be enrolled;
Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with an expected survival of ≥ 12 weeks;

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Adequate organ and bone marrow function
For female patients of childbearing age and male patients with partners of childbearing age, they must use effective medical contraception during the study treatment period and for 6 months after the last dose of study medication (see Annex for specific contraceptive measures);
Each patient must voluntarily agree to participate in the study, sign the informed consent form, and comply with the protocol-specified visits and relevant procedures.

Who cannot join

Presence of small cell lung carcinoma (SCLC) components in histological pathology;
History of other malignancies;
Presence of metastases to brainstem, meninges and spinal cord, or spinal cord compression;
Presence of active central nervous system (CNS) metastases;
Imaging (CT or MRI) shows that the tumor surrounds important blood vessels, or the investigator determines that the tumor is most likely to invade important blood vessels during the subsequent study to cause fatal major hemorrhage;
Serious or uncontrolled cardiac disease or clinical symptoms requiring treatment, including any of the following:

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Patients with (noninfectious) interstitial lung disease (ILD) or history of pneumonia requiring steroid therapy; patients with serious pulmonary function impairment due to lung disease;
Uncontrolled systemic disease as judged by the investigator, included uncontrolled hypertension, uncontrolled diabetes, pesence of pleural effusion, pericardial effusion, or ascites that is clinically symptomatic or requires repeated drainage;
Certain viral infections including active hepatitis B or hepatitis C; known history of positive human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS); or positive syphilis antibody test;
Known active tuberculosis;
Known hypersensitivity to the study drug or any of its components, or severe allergic reactions to other monoclonal antibodies;
Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
Pregnant or lactating women;
Any patient whose condition deteriorates rapidly during the screening process prior to the first dose, such as severe changes in performance status, unstable pain requiring adjustment of analgesic therapy, etc
Other circumstances that, in the opinion of the investigator, are not appropriate for participation in this study.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

XiaoPin Jin contact

028-67255165

jinxp@kelun.com

China2 sites, 2 recruiting

Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Li Zhang, professor, 021-87342288, zhangli@sysucc.org.cn
Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Li Zhang
Recruiting

Other trials in China

About this study

Official title: A Phase Ⅱ Clinical Study of Combination Therapy of SKB264 in Patients With Advanced or Metastatic Non-small Cell Lung Cancer

Conditions: Non-small Cell Lung Cancer
Being tested: SKB264, KL-A167, Carboplatin, Cisplatin
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

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

SKB264Drug
SKB264 will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (5mg/kg)
KL-A167Drug
KL-A167 will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (1200mg Q3W)
CarboplatinDrug
Carboplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle（AUC 5)
CisplatinDrug
Cisplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (75mg/m²)

Study groups in NCT05351788
Study group	Role	What they receive
SKB264+KL-A167	Experimental	Participants received SKB264 followed by KL-A167 Receives: Drug: SKB264; Drug: KL-A167
SKB264+KL-A167+ Carboplatin or Cisplatin (EGFR wide type)	Experimental	Participants received SKB264 followed by KL-A167 with Carboplatin or Cisplatin Receives: Drug: SKB264; Drug: KL-A167; Drug: Carboplatin; Drug: Cisplatin
SKB264+KL-A167+ Carboplatin or Cisplatin (EGFR mutation)	Experimental	Participants received SKB264 followed by KL-A167 with Carboplatin or Cisplatin Receives: Drug: SKB264; Drug: KL-A167; Drug: Carboplatin; Drug: Cisplatin

What is being measured

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

Incidence and severity of adverse events (AEs)
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: From baseline up to 30 days after last dose or to the beginning of the new anti-cancer therapy, up to 24 months
Objective Response Rate (ORR)
Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by Investigator based on RECIST version 1.1.
Measured: From baseline to first documented objective response, up to 24 months

Secondary outcomes (8)

Progression-free survival (PFS)
Progression-free survival (PFS) was defined as the time from baseline to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause. PD was defined as at least a 20% increase in the sum of diameters of target lesions.
Measured: From baseline to the first documented disease progression or date of death (whichever occurs first), up to 24 months
Duration of response (DOR)
Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR was measured for responding subjects (PR or CR) only.
Measured: From the date of first objective response (CR or PR) to the date of first documentation of PD or death (whichever occurs first), up to 24 months
Disease control rate (DCR)
Disease control rate (DCR) was defined as the sum of complete response (CR) rate, partial response (PR) rate, and stable disease (SD) rate. As per RECIST v1.1, CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
Measured: From baseline to date of first documented objective response (CR, PR, and SD), up to 24 months
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of SKB264-ADC, SKB264-TAB and free KL610023
Measured: Cycle 1-8, every 4 cycles starting from Cycle 12 Day 1: pre-dose, post-dose (each cycle is 21 days), up to 24 months
Pharmacokinetic Parameter Minimum Plasma Concentration (Cmin) of SKB264-ADC, SKB264-TAB and free KL610023
Measured: Cycle 1-8, every 4 cycles starting from Cycle 12 Day 1: pre-dose, post-dose (each cycle is 21 days), up to 24 months
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of KL-A167
Measured: Cycle 1-8, every 4 cycles starting from Cycle 12 Day 1: pre-dose, post-dose (each cycle is 21 days), up to 24 months
Pharmacokinetic Parameter Minimum Plasma Concentration (Cmin) of KL-A167
Measured: Cycle 1-8, every 4 cycles starting from Cycle 12 Day 1: pre-dose, post-dose (each cycle is 21 days), up to 24 months
Anti-drug Antibodies (ADA) for SKB264 and KL-A167
Measured: Cycle 1-8, every 4 cycles starting from Cycle 12 Day 1: pre-dose, post-dose (each cycle is 21 days), 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.

20 May 2022Dec 2026

First posted28 Apr 2022
Study start20 May 2022
Primary completionAug 2026 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Non-small Cell Lung CancerStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 110 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05351788
Sponsor's protocol ID: SKB264-Ⅱ-05
Status last verified: May 2026
First submitted: 24 Apr 2022
Last updated: 12 May 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Hong S, Wang Q, Cheng Y, Luo Y, Qu X, Zhu H, Ding Z, Li X, Wu L, Wang Y, Hu S, Wang E, Liu A, Sun Y, Fan Y, Ye F, Lu K, Fang J, Shen Y, Jin X, Ge J, Zhang L, Fang W. First-line sacituzumab tirumotecan with tagitanlimab in advanced non-small-cell lung cancer: a phase 2 trial. Nat Med. 2025 Nov;31(11):3654-3661. doi: 10.1038/s41591-025-03883-5. Epub 2025 Aug 19.
PubMed 40830660

Study at a glance

From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ⅱ Clinical Study of Combination Therapy of SKB264 in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT05351788
Acronym / sponsor ID: SKB264-Ⅱ-05
Conditions: Non-small Cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 110 participants (estimated)
Lead sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 20 May 2022 (actual)
Primary completion: Aug 2026 (estimated)
Study completion: Dec 2026 (estimated)
First posted: 28 Apr 2022 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
SKB264+KL-A167	Experimental	Drug: SKB264, Drug: KL-A167Participants received SKB264 followed by KL-A167
SKB264+KL-A167+ Carboplatin or Cisplatin (EGFR wide type)	Experimental	Drug: SKB264, Drug: KL-A167, Drug: Carboplatin, Drug: CisplatinParticipants received SKB264 followed by KL-A167 with Carboplatin or Cisplatin
SKB264+KL-A167+ Carboplatin or Cisplatin (EGFR mutation)	Experimental	Drug: SKB264, Drug: KL-A167, Drug: Carboplatin, Drug: CisplatinParticipants received SKB264 followed by KL-A167 with Carboplatin or Cisplatin

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Males or females ≥ 18 and ≤ 75 years of age at the time of signing the informed consent form;
Histologically and cytologically confirmed NSCLC;
Cohort 1: Patients with locally advanced/metastatic NSCLC with wild-type EGFR and negative ALK fusion gene, no or at most one prior line of systemic chemotherapy regimen for advanced or metastatic NSCLC. Cohort 2: Patients with locally advanced/metastatic NSCLC with wild-type EGFR and negative ALK fusion gene, no prior systemic therapy. Cohort 3: Patients with locally advanced/metastatic NSCLC with EGFR activating mutation and negative ALK fusion gene, who have failed previous treatment with EGFR-TKIs.
Provide fresh or archival tumor tissue for biomarker testing and analysis;
Patients with at least one measurable lesion per RECIST v1.1 criteria, and patients with only skin or bone lesions cannot be enrolled;

Key exclusion criteria (15 listed)

Presence of small cell lung carcinoma (SCLC) components in histological pathology;
History of other malignancies;
Presence of metastases to brainstem, meninges and spinal cord, or spinal cord compression;
Presence of active central nervous system (CNS) metastases;
Imaging (CT or MRI) shows that the tumor surrounds important blood vessels, or the investigator determines that the tumor is most likely to invade important blood vessels during the subsequent study to cause fatal major hemorrhage;

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
SKB264SKB264 will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (5mg/kg)	Drug	SKB264+KL-A167, SKB264+KL-A167+ Carboplatin or Cisplatin (EGFR mutation), SKB264+KL-A167+ Carboplatin or Cisplatin (EGFR wide type)
KL-A167KL-A167 will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (1200mg Q3W)	Drug	SKB264+KL-A167, SKB264+KL-A167+ Carboplatin or Cisplatin (EGFR mutation), SKB264+KL-A167+ Carboplatin or Cisplatin (EGFR wide type)
CarboplatinCarboplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle（AUC 5)	Drug	SKB264+KL-A167+ Carboplatin or Cisplatin (EGFR mutation), SKB264+KL-A167+ Carboplatin or Cisplatin (EGFR wide type)
CisplatinCisplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (75mg/m²)	Drug	SKB264+KL-A167+ Carboplatin or Cisplatin (EGFR mutation), SKB264+KL-A167+ Carboplatin or Cisplatin (EGFR wide type)

Primary outcome

Incidence and severity of adverse events (AEs)
Time frame: From baseline up to 30 days after last dose or to the beginning of the new anti-cancer therapy, up to 24 months
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Objective Response Rate (ORR)
Time frame: From baseline to first documented objective response, up to 24 months
Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by Investigator based on RECIST version 1.1.

8 secondary outcomes

Progression-free survival (PFS)
Time frame: From baseline to the first documented disease progression or date of death (whichever occurs first), up to 24 months
Duration of response (DOR)
Time frame: From the date of first objective response (CR or PR) to the date of first documentation of PD or death (whichever occurs first), up to 24 months
Disease control rate (DCR)
Time frame: From baseline to date of first documented objective response (CR, PR, and SD), up to 24 months
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of SKB264-ADC, SKB264-TAB and free KL610023
Time frame: Cycle 1-8, every 4 cycles starting from Cycle 12 Day 1: pre-dose, post-dose (each cycle is 21 days), up to 24 months
Pharmacokinetic Parameter Minimum Plasma Concentration (Cmin) of SKB264-ADC, SKB264-TAB and free KL610023
Time frame: Cycle 1-8, every 4 cycles starting from Cycle 12 Day 1: pre-dose, post-dose (each cycle is 21 days), up to 24 months
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of KL-A167
Time frame: Cycle 1-8, every 4 cycles starting from Cycle 12 Day 1: pre-dose, post-dose (each cycle is 21 days), up to 24 months
Pharmacokinetic Parameter Minimum Plasma Concentration (Cmin) of KL-A167
Time frame: Cycle 1-8, every 4 cycles starting from Cycle 12 Day 1: pre-dose, post-dose (each cycle is 21 days), up to 24 months
Anti-drug Antibodies (ADA) for SKB264 and KL-A167
Time frame: Cycle 1-8, every 4 cycles starting from Cycle 12 Day 1: pre-dose, post-dose (each cycle is 21 days), 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 12 May 2026.
Derived from this study: PubMed 40830660Hong S, Wang Q, Cheng Y, Luo Y, Qu X, Zhu H, Ding Z, Li X, Wu L, Wang Y, Hu S, Wang E, Liu A, Sun Y, Fan Y, Ye F, Lu K, Fang J, Shen Y, Jin X, Ge J, Zhang L, Fang W. First-line sacituzumab tirumotecan with tagitanlimab in advanced non-small-cell lung cancer: a phase 2 trial. Nat Med. 2025 Nov;31(11):3654-3661. doi: 10.1038/s41591-025-03883-5. Epub 2025 Aug 19.

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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.

XiaoPin Jin contact

028-67255165

jinxp@kelun.com

2 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 SKB264, KL-A167 and Carboplatin in people with Non-small Cell Lung Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 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 15 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 12 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 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 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 XiaoPin Jin (028-67255165, jinxp@kelun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events (AEs) (time frame: From baseline up to 30 days after last dose or to the beginning of the new anti-cancer therapy, up to 24 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 NCT05351788, 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 12 May 2026.