SKB571-based combination therapy for NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label phase II trial investigates the safety, tolerability, and preliminary efficacy of SKB571 in combination with other agents in NSCLC patients. Approximately 150 participants across three cohorts will receive SKB571 with agents such as Osimertinib, Furmonertinib, carboplatin, or cisplatin. The study will also evaluate pharmacokinetics and immunogenicity to understand how the therapy behaves in the body. Key eligibility includes confirmed NSCLC, measurable disease, good performance status, and adequate organ function. Exclusion criteria include recent other malignancies and active CNS metastases.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).
2. Participants must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
3. At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Life expectancy ≥ 12 weeks as assessed by the investigator.
6. Adequate organ and bone marrow function.
7. Male and female participants must agree to use highly effective methods of contraception during the study treatment period.
8. Participants must voluntarily join this study, sign the ICF, and be able to comply with the visits and related procedures specified in the protocol.

Exclusion Criteria:

1. Participants with other malignant tumors within 3 years before the first dose of study treatment.
2. Active or untreated central nervous system (CNS) metastasis.
3. Current uncontrolled concomitant diseases
4. Clinically severe lung damage due to complications of lung disorder
5. Participants with a history of interstitial lung disease (ILD)/non-infectious pneumonitis
6. A history of severe skin diseases
7. Unresolved toxicity from prior anti-tumor therapy
8. Serious infection within 4 weeks before the first dose of study treatment
9. Known active pulmonary tuberculosis.
10. Participants who have undergone major surgery or had severe trauma within 4 weeks before the first dose, or are expected to require major surgery during the study.
11. Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.
12. Pregnant or breastfeeding women.
13. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Guangzhou Medical University First Affiliated Hospital
  Guangzhou, Guangdong, China Recruiting
• Peking University Cancer Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Xinqiao Hospital of Army Medical University
  Chongqing, Chongqing Municipality, China Not yet recruiting
• Fujian Provincial Cancer Hospital
  Fuzhou, Fujian, China Not yet recruiting
• The First Affiliated Hospital of Xiamen University
  Xiamen, Fujian, China Not yet recruiting

Study contacts

• Study coordinator: Xin Li, MD
• Email: lixin@kelun.com
• Phone: 86-13311373861

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Patient-specific MRD liquid biopsy for resected NSCLC

  This study tests a personalized MRD blood and bronchial washing test after surgery to see if it can signal recurrence earlier in people with resected NSCLC.

  Recruiting Yonsei University · Yongin-si, Gyeonggi-do and 2 other locations · NCT07921888

• Osimertinib Plus SRS/SRT for EGFR-Mutant NSCLC with Symptomatic Brain Metastases

  This study tests whether adding targeted brain radiotherapy to osimertinib helps control brain metastases in adults with EGFR-mutant NSCLC and neurological symptoms.

  Recruiting Phase 2 Cho Ray Hospital · Ho Chi Minh City · NCT07911449

• Dato-DXd in solid tumors (Urothelial Cancer and KRAS-mutant NSCLC) in two sub-studies

  This study tests Datopotamab Deruxtecan (Dato-DXd) alone or with other cancer drugs in people with urothelial cancer or KRAS-mutant non-small cell lung cancer.

  Recruiting Phase 1/2 Daiichi Sankyo · Taichung · NCT07890714

• SI-B036 safety test in advanced and metastatic solid tumors

  This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.

  Recruiting at 4 sites Phase 1 SystImmune Inc. · New Haven, Connecticut and 6 other locations · NCT07857616

• Postoperative EGFR-TKI Therapy for EGFR-mutant NSCLC Following Surgery

  This registry tests whether giving an EGFR-TKI after surgery helps adults with EGFR-mutant, high-risk early-stage NSCLC.

  Recruiting Tongji Hospital · Wuhan, Hubei · NCT07837739

• HS-20093 with Adebrelimab vs HS-20093 alone in advanced non-squamous NSCLC

  This study tests whether adding adebrelimab to HS-20093 helps patients with advanced non-squamous NSCLC who have already had treatment.

  Recruiting Phase 2 Hansoh BioMedical R&D Company · Wuhan, Hubei · NCT07824882

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.