Non-Squamous Non-Small Cell Lung CancerPhase 2NCT07854509
A Phase II Study of SKB264 + SKB118 in Nsq-NSCLC After EGFR-TKI Failure
A Phase 2 study testing SKB264+SKB118 in people with Non-Squamous Non-Small Cell Lung Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd..
Trial summary
This is an open-label, multicenter, Phase II clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with locally advanced or metastatic non-squamous NSCLC harboring EGFR-sensitizing mutations who have failed EGFR-TKI therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Squamous Non-Small Cell Lung Cancer
- What is being tested?
- SKB264+SKB118
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 30 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
- Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-squamous NSCLC that is not suitable for radical surgery and/or radical radiotherapy (regardless of whether concurrent chemotherapy has been received).
- Confirmed EGFR-sensitizing mutations.
- Participants must have failed prior EGFR-TKI therapy for locally advanced or metastatic disease.
- Participants must be confirmed during the screening period to be able to provide a tumor tissue sample. If this cannot be met, acceptability should be discussed with the medical monitor.
- At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
- ECOG performance status of 0 or 1.
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- Life expectancy ≥ 12 weeks.
- Adequate bone marrow, liver, kidney, and coagulation function.
- Male and female participants must agree to use highly effective contraceptive measures during the specified period of the study.
Who cannot join
- Histologically or cytologically confirmed small cell lung cancer, neuroendocrine carcinoma, or sarcomatoid carcinoma components, or with a squamous component of more than 10%.
- Presence of known driver gene alterations with approved targeted therapies.
- Participants with known metastases to meninges, brainstem metastases, spinal cord metastases and/or compression, active or untreated brain metastases.
- Participants with other malignant tumors within 3 years prior to the first dose.
- Presence of uncontrolled, or symptomatic, or recurrent pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid therapy, current ILD or non-infectious pneumonia.
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- Presence of other moderate to severe lung disorders that may interfere with the detection or management of drug-related pulmonary toxicity and severely affect respiratory function.
- Risk of developing esophago-tracheal fistula or esophago-pleural fistula, or tumor invasion or compression of surrounding vital organs and major blood vessels.
- History of hemorrhagic diathesis or coagulopathy and/or clinically significant bleeding symptoms or risks.
- Previous or concurrent gastrointestinal diseases, surgery, and wound healing complications.
- Unresolved toxicity from prior anti-tumor therapy, defined as toxicity not recovered to Grade 0 or 1 of CTCAE v6.0, or to the level specified in the inclusion/exclusion criteria, with the exception of alopecia.
- Serious infection within 4 weeks before the first dose, active infection requiring systemic anti-infective therapy within 2 weeks before the first dose.
- Presence of active hepatitis B or hepatitis C or co-infection with HBV and HCV.
- Positive human immunodeficiency virus (HIV) test or known history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
- Known active tuberculosis.
- Known history of allogeneic organ transplant or hematopoietic stem cell transplant.
- With Grade ≥ 2 peripheral neuropathy.
- Active autoimmune disease requiring systemic treatment within the past two years.
- Participants who have received any of the following systemic anti-tumor therapies (including in the adjuvant or neoadjuvant setting):
- Prior treatment with immune checkpoint inhibitors, immune checkpoint agonists, or any therapy targeting the immune mechanism of the tumor, such as immune cell therapy.
- Prior treatment with PD-(L)1/VEGF bispecific antibodies or therapies targeting VEGF/VEGFR with monoclonal antibodies or small molecules.
- Therapy targeting TROP2.
- Any drug therapy targeting topoisomerase I, including antibody-drug conjugate (ADC) therapy.
- Pregnant or lactating women.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II Clinical Study to Evaluate Sacituzumab Tirumotecan (SKB264) in Combination With SKB118 for the Treatment of EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer in Participants Who Have Failed Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy
This is an open-label, multicenter, Phase II clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with locally advanced or metastatic non-squamous NSCLC harboring EGFR-sensitizing mutations who have failed EGFR-TKI therapy. The study includes a dose escalation phase and an expansion phase.
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Being tested
- SKB264+SKB118
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKB264+SKB118Drug
Administered by intravenous infusion on Day 1 and Day 15 of each 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| SKB264 in combination with SKB118 | Experimental | SKB264 (4 mg/kg or other dose levels) combined with SKB118 (10 mg/kg, 20 mg/kg, or other dose levels). Receives: Drug: SKB264+SKB118 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of SKB264 in combination with SKB118 in participants with non-squamous non-small cell lung cancer (NSCLC)
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (per Common Terminology Criteria for Adverse Events [CTCAE] v6.0)
Measured: From enrollment to the end of treatment at 24 months
ORR(objective response rate)
ORR as assessed by the investigator based on RECIST v1.1
Measured: From enrollment to the end of treatment at 24 months
Secondary outcomes (4)
DCR(Disease control rate )
as assessed by the investigator based on RECIST v1.1
Measured: From enrollment to the end of treatment at 24 months
DOR(duration of response )
as assessed by the investigator based on RECIST v1.1
Measured: From enrollment to the end of treatment at 24 months
PFS(progression-free survival)
as assessed by the investigator based on RECIST v1.1
Measured: From enrollment to the end of treatment at 24 months
OS (overall survival)
Measured: From enrollment to the end of treatment at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 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-Squamous 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854509
- Sponsor's protocol ID
- SKB264-II-21
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 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 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Evaluate Sacituzumab Tirumotecan (SKB264) in Combination With SKB118 for the Treatment of EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer in Participants Who Have Failed Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy
- ClinicalTrials.gov ID
- NCT07854509
- Acronym / sponsor ID
- SKB264-II-21
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 2 Oct 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 clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with locally advanced or metastatic non-squamous NSCLC harboring EGFR-sensitizing mutations who have failed EGFR-TKI therapy. The study includes a dose escalation phase and an expansion phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SKB264 in combination with SKB118 | Experimental | Drug: SKB264+SKB118SKB264 (4 mg/kg or other dose levels) combined with SKB118 (10 mg/kg, 20 mg/kg, or other dose levels). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-squamous NSCLC that is not suitable for radical surgery and/or radical radiotherapy (regardless of whether concurrent chemotherapy has been received).
- Confirmed EGFR-sensitizing mutations.
- Participants must have failed prior EGFR-TKI therapy for locally advanced or metastatic disease.
- Participants must be confirmed during the screening period to be able to provide a tumor tissue sample. If this cannot be met, acceptability should be discussed with the medical monitor.
- At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
Key exclusion criteria (24 listed)
- Histologically or cytologically confirmed small cell lung cancer, neuroendocrine carcinoma, or sarcomatoid carcinoma components, or with a squamous component of more than 10%.
- Presence of known driver gene alterations with approved targeted therapies.
- Participants with known metastases to meninges, brainstem metastases, spinal cord metastases and/or compression, active or untreated brain metastases.
- Participants with other malignant tumors within 3 years prior to the first dose.
- Presence of uncontrolled, or symptomatic, or recurrent pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
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 |
|---|---|---|
| SKB264+SKB118Administered by intravenous infusion on Day 1 and Day 15 of each 28-day cycle. | Drug | SKB264 in combination with SKB118 |
Primary outcome
The safety of SKB264 in combination with SKB118 in participants with non-squamous non-small cell lung cancer (NSCLC)
Time frame: From enrollment to the end of treatment at 24 months
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (per Common Terminology Criteria for Adverse Events [CTCAE] v6.0)
ORR(objective response rate)
Time frame: From enrollment to the end of treatment at 24 months
ORR as assessed by the investigator based on RECIST v1.1
4 secondary outcomes
DCR(Disease control rate )
Time frame: From enrollment to the end of treatment at 24 months
DOR(duration of response )
Time frame: From enrollment to the end of treatment at 24 months
PFS(progression-free survival)
Time frame: From enrollment to the end of treatment at 24 months
OS (overall survival)
Time frame: From enrollment to the end of treatment at 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 2 Oct 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SKB264+SKB118 in people with Non-Squamous Non-Small Cell Lung Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd..
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 24 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: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Xiaoping Jin, PhD (028-67255495, jinxp@kelun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of SKB264 in combination with SKB118 in participants with non-squamous non-small cell lung cancer (NSCLC) (time frame: From enrollment to the end of treatment at 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?
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 Oct 2026.