Non-Small Cell Lung CancerPhase 3NCT06670196
A Study of SKB264 in Combination With Osimertinib Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
A Phase 3 study testing SKB264 and Osimertinib in people with Non-Small Cell Lung Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with osimertinib as first-Line treatment for patients with epidermal growth factor receptor (EGFR) mutations, locally advanced or metastatic non-squamous non-small cell lung cancer. 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 and Osimertinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 27 Nov 2024to Jul 2027
- Phase
- Phase 3
- 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
- Aged ≥18 years to ≤75 years at the time of signing the informed consent form (ICF), regardless of gender.
- Histologically or cytologically confirmed non-squamous NSCLC that is locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous NSCLC not eligible to radical surgery and/or radical radiotherapy.
- No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.
- Histologically or cytologically confirmed EGFR-sensitive mutations.
- Tumor tissue samples obtained at or after the diagnosis of locally advanced or metastatic tumor are eligible.
- At least one target lesion assessed by the investigator based on RECIST v1.1.
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- ECOG performance status score of 0 or 1 within 7 days prior to randomization.
- Life expectancy ≥ 12 weeks.
- Adequate organ and bone marrow function.
Who cannot join
- Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components or squamous cell carcinoma components of more than 10%.
- Subjects who have received prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.
- Subjects who have received any of the following therapies (including the adjuvant/neoadjuvant therapy):
- Targeted TROP2 therapy;
- Any drug therapy that targets topoisomerase I, including antibody-drug conjugates (ADCs).
- Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, active or central nervous system (CNS) metastase.
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- Other malignancies within 3 years prior to randomization.
- Clinically significant abnormalities found on resting electrocardiogram (ECG)
- Presence of any of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
- History of interstitial lung disease (ILD), drug-induced ILD, history of non-infectious pneumonitis requiring steroid treatment, current ILD or non-infectious pneumonitis.
- Clinically severe lung injuries caused by lung diseases.
- Unresolved toxicities from previous anti-tumor therapy to ≤ Grade 1 (based on NCI CTCAE v5.0) or the level specified in the inclusion and exclusion criteria.
- Subjects who have received systemic corticosteroids > 10 mg/day of prednisone or other immunosuppressive agents within 2 weeks prior to randomization.
- Known active pulmonary tuberculosis.
- Known history of allogeneic organ transplant and allogeneic hematopoietic stem cell transplant.
- Presence of active hepatitis B or hepatitis C.
- Positive result of human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
- Known allergy to osimertinib, SKB264 or any of their components (including but not limited to polysorbate-20), history of severe hypersensitivity to other biologics.
- Vaccination with live vaccines within 30 days prior to randomization, or planned vaccination with live vaccines during the study.
- Women who are pregnant or breastfeeding.
- Presence of local or systemic diseases caused by non-malignancies, or diseases or symptoms secondary to tumors.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Multicenter, Phase III Clinical Study of SKB264 in Combination With Osimertinib Versus Osimertinib Alone as First-Line Treatment for Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with osimertinib as first-Line treatment for patients with epidermal growth factor receptor (EGFR) mutations, locally advanced or metastatic non-squamous non-small cell lung cancer.
Read the detailed description
This is a randomized, open-Label, multicenter, Phase 3 study to evaluate the efficacy and safety of SKB264 in combination with osimertinib versus osimertinib alone as first-line treatment for patients with EGFR mutations, locally advanced or metastatic non-squamous non-small cell lung cancer.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- SKB264, Osimertinib
- Keywords
- SKB264, NSCLC
- 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
4mg/kg, intravenous (IV) infusion
OsimertinibDrug
80mg, QD
| Study group | Role | What they receive |
|---|---|---|
| SKB264+Osimertinib | Experimental | Participants will receive SKB264 on Day 1 and Day 15 of each 4-week cycle, Osimertinib once-daily for each 4-week cycle. Receives: Drug: SKB264; Drug: Osimertinib |
| Osimertinib | Active comparator | Participants will receive Osimertinib once-daily for each 4-week cycle. Receives: Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first.
Measured: Randomization up to approximately 36 months
Secondary outcomes (6)
Overall Survival (OS)
OS is defined as the time from randomization until the date of death due to any cause.
Measured: Randomization up to approximately 49 months
Progression-Free Survival (PFS) assessed by Investigator
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator or death due to any cause, whichever occurs first.
Measured: Randomization up to approximately 36 months
Objective Response Rate (ORR)
ORR is defined as the percentage of patients who achieve complete response(CR) or partial response (PR), as assessed by BICR/investigator per RECIST 1.1
Measured: Randomization up to approximately 36 months
Disease control rate (DCR)
DCR is defined as the percentage of patients who achieve CR, PR or stable disease (SD), as assessed by BICR/ investigator per RECIST 1.1
Measured: Randomization up to approximately 36 months
Duration of Response (DoR)
DoR is defined as the time from the date of first documented CR or PR until date of documented disease progression per RECIST 1.1, as assessed by BICR/investigator or death due to any cause, whichever occurs first.
Measured: Randomization up to approximately 36 months
Time to Response (TTR)
TTR is defined as the time from the date of randomization until the first documentation of CR or PR as assessed by BICR/investigator per RECIST 1.1.
Measured: Randomization 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 posted1 Nov 2024
- Study start27 Nov 2024
- Primary completionMay 2027 (estimated)
- Study completionJul 2027 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomised in a 1:1 ratio to one of two intervention groups.
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670196
- Sponsor's protocol ID
- SKB264-Ⅲ-15
- Status last verified
- May 2026
- First submitted
- 31 Oct 2024
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multicenter, Phase III Clinical Study of SKB264 in Combination With Osimertinib Versus Osimertinib Alone as First-Line Treatment for Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06670196
- Acronym / sponsor ID
- SKB264-Ⅲ-15
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- SKB264, NSCLC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 1 Nov 2024 (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.
The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with osimertinib as first-Line treatment for patients with epidermal growth factor receptor (EGFR) mutations, locally advanced or metastatic non-squamous non-small cell lung cancer.
Detailed description
This is a randomized, open-Label, multicenter, Phase 3 study to evaluate the efficacy and safety of SKB264 in combination with osimertinib versus osimertinib alone as first-line treatment for patients with EGFR mutations, locally advanced or metastatic non-squamous non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomised in a 1:1 ratio to one of two intervention groups.
| Arm | Type | Receives |
|---|---|---|
| SKB264+Osimertinib | Experimental | Drug: SKB264, Drug: OsimertinibParticipants will receive SKB264 on Day 1 and Day 15 of each 4-week cycle, Osimertinib once-daily for each 4-week cycle. |
| Osimertinib | Active comparator | Drug: OsimertinibParticipants will receive Osimertinib once-daily for each 4-week cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged ≥18 years to ≤75 years at the time of signing the informed consent form (ICF), regardless of gender.
- Histologically or cytologically confirmed non-squamous NSCLC that is locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous NSCLC not eligible to radical surgery and/or radical radiotherapy.
- No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.
- Histologically or cytologically confirmed EGFR-sensitive mutations.
- Tumor tissue samples obtained at or after the diagnosis of locally advanced or metastatic tumor are eligible.
Key exclusion criteria (21 listed)
- Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components or squamous cell carcinoma components of more than 10%.
- Subjects who have received prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.
- Subjects who have received any of the following therapies (including the adjuvant/neoadjuvant therapy):
- Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, active or central nervous system (CNS) metastase.
- Other malignancies within 3 years prior to randomization.
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 |
|---|---|---|
| SKB2644mg/kg, intravenous (IV) infusion | Drug | SKB264+Osimertinib |
| Osimertinib80mg, QD | Drug | Osimertinib, SKB264+Osimertinib |
Primary outcome
Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
Time frame: Randomization up to approximately 36 months
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first.
6 secondary outcomes
Overall Survival (OS)
Time frame: Randomization up to approximately 49 months
Progression-Free Survival (PFS) assessed by Investigator
Time frame: Randomization up to approximately 36 months
Objective Response Rate (ORR)
Time frame: Randomization up to approximately 36 months
Disease control rate (DCR)
Time frame: Randomization up to approximately 36 months
Duration of Response (DoR)
Time frame: Randomization up to approximately 36 months
Time to Response (TTR)
Time frame: Randomization 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 10 Jul 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SKB264 and Osimertinib in people with Non-Small Cell Lung Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 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 9 inclusion and 21 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 10 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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) assessed by Blinded Independent Central Review (BICR) (time frame: Randomization 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 10 Jul 2026.