Evaluating SKB264 for patients with EGFR mutant non-small cell lung cancer

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 study is testing if a new drug called SKB264 can help people with EGFR mutant non-small cell lung cancer who haven't responded to previous treatments, compared to a standard combination of other cancer drugs.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 356 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05870319 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical study is a randomized, open-label, multicenter trial that compares the efficacy and safety of SKB264 monotherapy against pemetrexed combined with platinum in patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have previously failed EGFR-TKI therapy. The study aims to enroll patients with confirmed EGFR mutations and assess their response to the treatments. The primary objective is to determine which treatment provides better outcomes for these patients.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with advanced non-squamous NSCLC and confirmed EGFR mutations who have failed prior EGFR-TKI therapy.

Not a fit: Patients with squamous cell NSCLC or those who have not failed EGFR-TKI therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new effective treatment option for patients with EGFR mutant NSCLC who have not responded to previous therapies.

How similar studies have performed: Other studies have shown promising results with similar approaches in treating EGFR mutant NSCLC, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Males or females aged ≥18 to ≤75 years at the time of signing the ICF;
2. 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;
3. EGFR-sensitive mutations;
4. Failure of prior EGFR-TKI therapy;
5. At least one measurable target lesion per RECIST 1.1 as assessed by the investigator;
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
7. Expected survival ≥12 weeks;
8. Adequate organ and bone marrow function;
9. 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;
10. Subjects voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures

Exclusion Criteria:

1. Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components or squamous cell carcinoma components of more than 10%;
2. Other malignancies within 3 years prior to the first dose;
3. History of (noninfectious) interstitial lung disease (ILD)/noninfectious pneumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis;
4. Subjects with active chronic inflammatory bowel disease, GI tract obstruction, severe ulcers, perforation gastrointestinal, abdominal abscess, or acute GI tract bleed;
5. 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;
6. Subjects with human immunodeficiency virus (HIV) test positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection;
7. Prior TROP2-targeted therapy;
8. Prior treatment with any drug therapy targeting topoisomerase I inhibitor, including antibody-drug conjugates (ADCs);
9. Major surgery within 4 weeks prior to the first dose or expected to require major surgery during the study;
10. Subjects who have received live vaccines within 30 days prior to the first dose, or are scheduled to receive live vaccines during the study;
11. Pregnant or lactating women;

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Xiaoping Jin, PhD

Conditions Non-small Cell Lung Cancer