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Non-small Cell Lung CancerPhase 3NCT05870319

A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients

A Phase 3 study testing SKB264, Pemetrexed and Carboplatin in people with Non-small Cell Lung Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a randomized, open-label, multicenter Phase 3 clinical study to evaluate SKB264 monotherapy versus pemetrexed in combination with platinum in subjects with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy. 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, Pemetrexed and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
376 participants
Where
1 siteChina
Study dates
26 Jun 2023to 30 Sep 2026
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

  • Males or females aged ≥18 to ≤75 years at the time of signing the ICF;
  • Histologically or cytologically confirmed non-squamous NSCLC and locally advanced (stage IIIB/IIIC) or metastatic (Stage IV) non-squamous NSCLC not amenable to radical surgery and/or radical concurrent/sequential chemoradiotherapy;
  • EGFR-sensitive mutations;
  • Failure of prior EGFR-TKI therapy;
  • At least one measurable target lesion per RECIST 1.1 as assessed by the investigator;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
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  • Expected survival ≥12 weeks;
  • Adequate organ and bone marrow function;
  • Female subjects of childbearing potential and male subjects with partners of childbearing potential who use effective medical contraception from the time of signing the informed consent form until 6 months after the last dose;
  • Subjects voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures

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%;
  • Other malignancies within 3 years prior to the first dose;
  • History of (noninfectious) interstitial lung disease (ILD)/noninfectious pneumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis;
  • Subjects with active chronic inflammatory bowel disease, GI tract obstruction, severe ulcers, perforation gastrointestinal, abdominal abscess, or acute GI tract bleed;
  • Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1 (per NCI CTCAE 5.0) or to the level specified in the eligibility criteria;
  • Subjects with human immunodeficiency virus (HIV) test positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection;
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  • Prior TROP2-targeted therapy;
  • Prior treatment with any drug therapy targeting topoisomerase I inhibitor, including antibody-drug conjugates (ADCs);
  • Major surgery within 4 weeks prior to the first dose or expected to require major surgery during the study;
  • Subjects who have received live vaccines within 30 days prior to the first dose, or are scheduled to receive live vaccines during the study;
  • Pregnant or lactating women;

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: A Randomized, Open-Label, Multicenter Phase 3 Study to Evaluate SKB264 Monotherapy Versus Pemetrexed in Combination With Platinum in Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With EGFR Mutation Who Have Failed to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy

This is a randomized, open-label, multicenter Phase 3 clinical study to evaluate SKB264 monotherapy versus pemetrexed in combination with platinum in subjects with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy.

Read the detailed description

This is a randomized, open-label, multicenter Phase 3 clinical study to evaluate SKB264 monotherapy versus pemetrexed in combination with platinum in subjects with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy. The primary objective is to compare the efficacy and safety of SKB264 monotherapy versus pemetrexed in combination with platinum in patients with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy.

Being tested
SKB264, Pemetrexed, 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

    intravenous (IV) infusion (Q2W)

  • PemetrexedDrug

    500 mg/m2 intravenous (IV) infusion (Q3W)

  • CarboplatinDrug

    AUC 5 intravenous (IV) infusion (Q3W) 4cycles

  • CisplatinDrug

    75 mg/m2 intravenous (IV) infusion (Q3W) 4cycles

Study groups in NCT05870319
Study groupRoleWhat they receive
SKB264 by IV infusion on Days 1 and 15 of each 4-week cycle;ExperimentalNot described
Receives: Drug: SKB264
pemetrexed+ carboplatin or on Day 1 of each 3-week cycle, with 4 cycles chemoActive comparatorNot described
Receives: Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin

What is being measured

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

  1. Progression-free survival (PFS)

    PFS assessed by BIRC per RECIST 1.1

    Measured: From baseline until disease progression, death, or other protocol defined reason,up to approximately 36 months

Secondary outcomes (9)

  1. Overall survival (OS)

    Overall survival (OS)

    Measured: From the date of randomization to the date of death due to any cause. Up to 2 years.

  2. Progression-free survival (PFS)

    PFS assessed by the investigator per RECIST 1.1

    Measured: From baseline until disease progression, death, or other protocol defined reason,up to approximately 36 months

  3. Objective response rate(ORR)

    ORR assessed by the investigator and BIRC per RECIST 1.1

    Measured: Up to 2 years

  4. Disease control rate(DCR)

    DCR assessed by the investigator and BIRC per RECIST 1.1

    Measured: Up to 2 years

  5. Duration of response(DOR)

    DOR assessed by the investigator and BIRC per RECIST 1.1

    Measured: From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months

  6. Time to response(TTR)

    TTR assessed by the investigator and BIRC per RECIST 1.1

    Measured: Up to 2 years

  7. AEs and SAEs

    Incidence and severity of AEs and SAEs (per CTCAE 5.0), and clinically significant abnormal laboratory findings

    Measured: AEs should be observed and recorded from signing the ICF until 30 days after the last dose. AEs occurring 30 days after the last dose are not required to be actively collected by the investigator.

  8. Mean change from baseline in the European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality-of-life questionnaire (QLQ-C30）

    To assess the impact of SKB264 on disease related symptoms and health related quality of life (HRQoL) in this patient population.

    Measured: Up to 2 years

  9. Mean change from baseline in the European Organisation for Research and Treatment of Cancer (EORTC) complementary 13-item quality-of-life questionnaire - lung cancer symptoms questionnaire (QLQ-LC13)

    To assess the impact of SKB264 on disease related symptoms and health related quality of life (HRQoL) in this patient population

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2023
  2. Study start26 Jun 2023
  3. Primary completion11 Jul 2024
  4. Study completion30 Sep 2026 (estimated)

Resources

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
Masking
None (open label)
Enrolment
376 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05870319
Sponsor's protocol ID
SKB264-Ⅲ-09
Status last verified
May 2026
First submitted
18 Apr 2023
Last updated
8 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Fang W, Wu L, Meng X, Yao Y, Zuo W, Yao W, Xie Y, Zhang Y, Cui J, Zhang Y, Li X, Zhuang W, Fang J, Wang Q, Jiang W, Li K, Bai Y, Luo Y, Ma F, Yu Y, Zheng W, Liu Z, Yang B, Ma R, Fang Y, Yang R, Jiang L, Hu J, Yang J, Diao Y, Jin X, Ge J, Yang Y, Zhang L. Sacituzumab Tirumotecan in EGFR-TKI-Resistant, EGFR-Mutated Advanced NSCLC. N Engl J Med. 2026 Jan 1;394(1):13-26. doi: 10.1056/NEJMoa2512071. Epub 2025 Oct 19.

    PubMed 41124220

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SKB264, Pemetrexed and Carboplatin 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 10 inclusion and 11 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 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 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) (time frame: From baseline until disease progression, death, or other protocol defined reason,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?

On the ClinicalTrials.gov record for NCT05870319, 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 8 May 2026.

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