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NCT05870319 | RECRUITING | Non-small Cell Lung Cancer

A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients
Sponsor:

Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

Brief 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.

Condition or disease

Non-small Cell Lung Cancer

Intervention/treatment

SKB264

Pemetrexed

Carboplatin

Cisplatin

Phase

PHASE3

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 356 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2023-06-26
Estimated Primary Completion Date : 2025-05-20
Estimated Study Completion Date : 2026-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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;
A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients

Location Details

NCT05870319

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Locations

RECRUITING

China, Guangdong

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060