Non-Small Cell Lung CancerPhase 2NCT07622186
A Study of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing SKB571 for injection, Osimertinib and Furmonertinib in people with Non-Small Cell Lung Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 27 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 SKB571 Combination Therapy in participants with Non-Small Cell Lung Cancer (NSCLC). 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?
- SKB571 for injection, Osimertinib and Furmonertinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 27 sitesChina
- Study dates
- 15 Jul 2026to 31 Dec 2029
- 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
- Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).
- Participants must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
- At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 12 weeks as assessed by the investigator.
- Adequate organ and bone marrow function.
- Male and female participants must agree to use highly effective methods of contraception during the study treatment period.
- Participants must voluntarily join this study, sign the ICF, and be able to comply with the visits and related procedures specified in the protocol.
Who cannot join
- Participants with other malignant tumors within 3 years before the first dose of study treatment.
- Active or untreated central nervous system (CNS) metastasis.
- Current uncontrolled concomitant diseases
- Clinically severe lung damage due to complications of lung disorder
- Participants with a history of interstitial lung disease (ILD)/non-infectious pneumonitis
- A history of severe skin diseases
Show all 13Show fewer
- Unresolved toxicity from prior anti-tumor therapy
- Serious infection within 4 weeks before the first dose of study treatment
- Known active pulmonary tuberculosis.
- Participants who have undergone major surgery or had severe trauma within 4 weeks before the first dose, or are expected to require major surgery during the study.
- Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.
- Pregnant or breastfeeding women.
- Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
China27 sites, 27 recruiting
- Not yet recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Jian Fang
- Not yet recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130012
Haifeng Liu
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Bolin Chen
Xingxiang Pu
- Not yet recruiting
Sichuan Cancer Hospital & Institute
Chengdu, Sichuan, 610041
Wenxiu Yao
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Guowei Che
- Not yet recruiting
Xinqiao Hospital of Army Medical University
Chongqing, Chongqing Municipality, 400037
Zhi Xu
- Not yet recruiting
Dongguan People's Hospital
Dongguan, Guangdong, 523018
Guanming Jiang
- Not yet recruiting
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350014
Jing Zhang
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Li Zhang
- Recruiting
Guangzhou Medical University First Affiliated Hospital
Guangzhou, Guangdong, 510120
Chengzhi Zhou
- Not yet recruiting
Guilin Medical University First Affiliated Hospital
Guilin, Guangxi, 541001
Yanyi Zhao
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Xinmin Yu
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Yan Yu
Qingwei Meng
- Not yet recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Haiyong Wang
Yan Zhang
- Not yet recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650118
Runxiang Yang
- Not yet recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Zhentian Liu
- Not yet recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Wangjian Zha
- Not yet recruiting
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530021
Yun Zhao
Qitao Yu
- Not yet recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Wei Zheng
- Not yet recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030013
Wei Guo
- Not yet recruiting
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060
Liuchun Wang
- Not yet recruiting
Xinjiang Medical University Affiliated Tumor Hospital
Ürümqi, Xinjiang Uygur Autonomous Region, 830011
Chunling Liu
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, 710061
Yu Yao
- Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Jingxun Wu
- Not yet recruiting
Xiangyang Central Hospital
Xiangyang, Hubei, 441021
Tienan Yi
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Qiming Wang
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Siyuan Huang
About this study
Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)
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 SKB571 Combination Therapy in participants with Non-Small Cell Lung Cancer (NSCLC).
Read the detailed description
This is a multicenter, open-label, Phase II clinical study to evaluate the efficacy, safety, tolerability, PK characteristics, and immunogenicity of SKB571Combination Therapy in participants with Non-Small Cell Lung Cancer (NSCLC). Approximately 150 subjects will be enrolled in this study, including 3 cohorts.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- SKB571 for injection, Osimertinib, Furmonertinib, 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.
SKB571 for injectionDrug
Intravenous(IV) infusion(Q3W)
OsimertinibDrug
orally once daily
FurmonertinibDrug
orally once daily
carboplatinDrug
Intravenous(IV) infusion(Q3W)
CisplatinDrug
Intravenous(IV) infusion(Q3W)
PembrolizumabDrug
Intravenous(IV) infusion(Q3W)
| Study group | Role | What they receive |
|---|---|---|
| NSCLC with sensitive EGFR mutations | Experimental | Not described Receives: Drug: SKB571 for injection; Drug: Osimertinib; Drug: Furmonertinib |
| NSCLC with EGFR wild-type | Experimental | Not described Receives: Drug: SKB571 for injection; Drug: carboplatin; Drug: Cisplatin; Drug: Pembrolizumab |
| NSCLC with uncommon EGFR mutations | Experimental | Not described Receives: Drug: SKB571 for injection; Drug: Furmonertinib; Drug: carboplatin; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Measured: Up to approximately 36 months
Secondary outcomes (9)
Progression-free survival (PFS), duration of response (DOR), disease control rate (DCR), and overall survival (OS)
Measured: Up to approximately 36 months
Safety and tolerability
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (based on CTCAE v6.0), clinically significant abnormal laboratory test results, etc.
Measured: Up to approximately 36 months
Maximum Plasma Concentration (Cmax) of SKB571-ADC
Blood Samples will be collected to determine the Cmax of SKB571-ADC in the plasma
Measured: Up to approximately 36 months
Immunogenicity
Blood Samples will be collected to measure Anti-drug antibody (ADA) against SKB571 in the serum
Measured: Up to approximately 36 months
Minimum Plasma Concentration(Cmin) of SKB571-ADC
Blood samples will be collected to determine the Cmin of SKB571-ADC in the plasma
Measured: Up to approximately 36 months
Maximum Plasma Concentration(Cmax) of SKB571-TAb
Blood samples will be collected to determine the Cmax of SKB571-TAb in the plasma
Measured: Up to approximately 36 months
Minimum Plasma Concentration(Cmin) of SKB571-TAb
Blood Samples will be collected to determine the Cmin of SKB571-TAb in the plasma
Measured: Up to approximately 36 months
Maximum Plasma Concentration (Cmax) of unconjugated KL610348
Blood Samples will be collected to determine the Cmax of unconjugated KL610348 in the plasma
Measured: Up to approximately 36 months
Minimum Plasma Concentration(Cmin) of unconjugated KL610348
Blood Samples will be collected to determine the Cmin of unconjugated KL610348 in the plasma
Measured: Up to approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start15 Jul 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xin Li, MD, Study director, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622186
- Sponsor's protocol ID
- SKB571-II-05
- Status last verified
- Aug 2026
- First submitted
- 26 May 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT07622186
- Acronym / sponsor ID
- SKB571-II-05
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Jun 2026 (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 SKB571 Combination Therapy in participants with Non-Small Cell Lung Cancer (NSCLC).
Detailed description
This is a multicenter, open-label, Phase II clinical study to evaluate the efficacy, safety, tolerability, PK characteristics, and immunogenicity of SKB571Combination Therapy in participants with Non-Small Cell Lung Cancer (NSCLC). Approximately 150 subjects will be enrolled in this study, including 3 cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NSCLC with sensitive EGFR mutations | Experimental | Drug: SKB571 for injection, Drug: Osimertinib, Drug: Furmonertinib |
| NSCLC with EGFR wild-type | Experimental | Drug: SKB571 for injection, Drug: carboplatin, Drug: Cisplatin, Drug: Pembrolizumab |
| NSCLC with uncommon EGFR mutations | Experimental | Drug: SKB571 for injection, Drug: Furmonertinib, Drug: carboplatin, Drug: Cisplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).
- Participants must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
- At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 12 weeks as assessed by the investigator.
Key exclusion criteria (13 listed)
- Participants with other malignant tumors within 3 years before the first dose of study treatment.
- Active or untreated central nervous system (CNS) metastasis.
- Current uncontrolled concomitant diseases
- Clinically severe lung damage due to complications of lung disorder
- Participants with a history of interstitial lung disease (ILD)/non-infectious pneumonitis
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 |
|---|---|---|
| SKB571 for injectionIntravenous(IV) infusion(Q3W) | Drug | NSCLC with EGFR wild-type, NSCLC with sensitive EGFR mutations, NSCLC with uncommon EGFR mutations |
| Osimertiniborally once daily | Drug | NSCLC with sensitive EGFR mutations |
| Furmonertiniborally once daily | Drug | NSCLC with sensitive EGFR mutations, NSCLC with uncommon EGFR mutations |
| carboplatinIntravenous(IV) infusion(Q3W) | Drug | NSCLC with EGFR wild-type, NSCLC with uncommon EGFR mutations |
| CisplatinIntravenous(IV) infusion(Q3W) | Drug | NSCLC with EGFR wild-type, NSCLC with uncommon EGFR mutations |
| PembrolizumabIntravenous(IV) infusion(Q3W) | Drug | NSCLC with EGFR wild-type |
Primary outcome
Objective response rate (ORR)
Time frame: Up to approximately 36 months
9 secondary outcomes
Progression-free survival (PFS), duration of response (DOR), disease control rate (DCR), and overall survival (OS)
Time frame: Up to approximately 36 months
Safety and tolerability
Time frame: Up to approximately 36 months
Maximum Plasma Concentration (Cmax) of SKB571-ADC
Time frame: Up to approximately 36 months
Immunogenicity
Time frame: Up to approximately 36 months
Minimum Plasma Concentration(Cmin) of SKB571-ADC
Time frame: Up to approximately 36 months
Maximum Plasma Concentration(Cmax) of SKB571-TAb
Time frame: Up to approximately 36 months
Minimum Plasma Concentration(Cmin) of SKB571-TAb
Time frame: Up to approximately 36 months
Maximum Plasma Concentration (Cmax) of unconjugated KL610348
Time frame: Up to approximately 36 months
Minimum Plasma Concentration(Cmin) of unconjugated KL610348
Time frame: Up to approximately 36 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 2 Sep 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.
Xin Li, MD study director
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
27 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 SKB571 for injection, Osimertinib and Furmonertinib in people with Non-Small Cell Lung Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 27 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 8 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: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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, MD (86-13311373861, lixin@kelun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Up to approximately 36 months). 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 2 Sep 2026.