NCT06670196 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
| NCT ID | NCT06670196 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
| Condition | Non-Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 420 participants |
| Start Date | 2024-11-27 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 420 participants in total. It began in 2024-11-27 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Aged ≥18 years to ≤75 years at the time of signing the informed consent form (ICF), regardless of gender. 2. 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. 3. No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC. 4. Histologically or cytologically confirmed EGFR-sensitive mutations. 5. Tumor tissue samples obtained at or after the diagnosis of locally advanced or metastatic tumor are eligible. 6. At least one target lesion assessed by the investigator based on RECIST v1.1. 7. ECOG performance status score of 0 or 1 within 7 days prior to randomization. 8. Life expectancy ≥ 12 weeks. 9. Adequate organ and bone marrow function. 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. Subjects who have received prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC. 3. Subjects who have received any of the following therapies (including the adjuvant/neoadjuvant therapy): 1. Targeted TROP2 therapy; 2. Any drug therapy that targets topoisomerase I, including antibody-drug conjugates (ADCs). 4. Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, active or central nervous system (CNS) metastase. 5. Other malignancies within 3 years prior to randomization. 6. Clinically significant abnormalities found on resting electrocardiogram (ECG) 7. Presence of any of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors. 8. History of interstitial lung disease (ILD), drug-induced ILD, history of non-infectious pneumonitis requiring steroid treatment, current ILD or non-infectious pneumonitis. 9. Clinically severe lung injuries caused by lung diseases. 10. 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. 11. Subjects who have received systemic corticosteroids \> 10 mg/day of prednisone or other immunosuppressive agents within 2 weeks prior to randomization. 12. Known active pulmonary tuberculosis. 13. Known history of allogeneic organ transplant and allogeneic hematopoietic stem cell transplant. 14. Presence of active hepatitis B or hepatitis C. 15. Positive result of human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection. 16. Known allergy to osimertinib, SKB264 or any of their components (including but not limited to polysorbate-20), history of severe hypersensitivity to other biologics. 17. Vaccination with live vaccines within 30 days prior to randomization, or planned vaccination with live vaccines during the study. 18. Women who are pregnant or breastfeeding. 19. Presence of local or systemic diseases caused by non-malignancies, or diseases or symptoms secondary to tumors.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06670196 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Non-Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06670196 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 420 participants.
Is NCT06670196 currently recruiting?
Yes, NCT06670196 is actively recruiting participants. Contact the research team at jinxp@kelun.com for enrollment information.
Where is the NCT06670196 trial being conducted?
This trial is being conducted at Guangzhou, China, Guangzhou, China.
Who is sponsoring the NCT06670196 clinical trial?
NCT06670196 is sponsored by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.. The trial plans to enroll 420 participants.
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