SKB500 combination treatments for extensive-stage small cell lung cancer

A Phase II, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of SKB500 Combinations in Patients With Small Cell Lung Cancer

This trial tests SKB500 given with other medicines in adults with extensive-stage small cell lung cancer to see if the combinations are safe and show tumor-fighting activity.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07296809 on ClinicalTrials.gov

What this trial studies

This Phase 2 study gives SKB500 in combination with agents such as KL-A167, carboplatin, and etoposide to adults with extensive-stage small cell lung cancer. The trial has a safety run-in (Part 1) to establish tolerability and a cohort expansion (Part 2) to look for preliminary antitumor activity. Eligible participants must have measurable disease by RECIST v1.1, ECOG performance status 0–1, adequate organ function, and agree to provide tumor tissue for biomarker analysis. All treatment and follow-up visits are conducted at the study site in Guangzhou.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically or cytologically confirmed extensive-stage small cell lung cancer, ECOG 0–1, at least one measurable lesion, adequate organ and marrow function, and willingness to provide tumor tissue and consent are the intended participants.

Not a fit: Patients with ECOG performance status ≥2, inadequate organ or bone marrow function, more than one prior systemic therapy in the extensive stage, or inability to attend the Guangzhou site are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, these combinations could provide a new treatment option that improves tumor control or the durability of response for patients with extensive-stage small cell lung cancer.

How similar studies have performed: While prior trials combining chemotherapy with novel targeted or immune agents have produced benefits in extensive-stage SCLC, SKB500 combinations are a novel approach with limited prior clinical data.

Eligibility criteria

Inclusion Criteria:

1. Male or female participants between 18 and 75 years old.
2. Histologically or cytologically confirmed Extensive-stage small cell lung cancer (ES-SCLC):

   * Cohort 1: participant has received or not received prior systemic treatment, with no more than 1 prior systemic therapy in the extensive stage.
   * Cohort 2\~3: participant has received no prior systemic treatment.
3. Agree to provide fresh or archival tumor tissue for biomarker analysis.
4. Has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Life expectancy \>= 12 weeks.
7. Has adequate organ and bone marrow functions.
8. Has recovered to grade ≤ 1 of prior anti-cancer treatment toxicities.
9. Effective contraceptive methods should be used during the study and for 6 months after the end of treatment.
10. Voluntarily join this study, sign the informed consent form, and can comply with the protocol-specified visits and procedures.

Exclusion Criteria:

1. The pathology suggests the presence of both non-small cell carcinoma and small cell carcinoma components.
2. Has previously received medications with the same target or the same toxins.
3. Presence of spinal cord compression or clinically active central nervous system metastases.
4. Presence of clinical symptoms caused by tumor invasion or compression of important organs and blood vessels.
5. Severe infection within 4 weeks or active infection requiring systemic anti-infective treatment within 2 weeks prior to the first dose.
6. With peripheral neuropathy of grade ≥ 2.
7. History of any serious, life threatening, or permanently discontinuing adverse events mediated by immunotherapy, including infusion reactions.
8. Presence of uncontrolled concurrent diseases, including but not limited to decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, Severe active peptic ulcer, gastrointestinal bleeding, gastrointestinal perforation, intestinal obstruction, etc.
9. Serious or uncontrolled heart disease or clinical symptoms requiring treatment.
10. History of interstitial lung disease (ILD) /noninfectious pneumonitis that require steroid treatment, or currently has ILD/noninfectious pneumonitis.
11. Clinical severe lung damage caused by concurrent lung disease.
12. Uncontrolled hypertension, diabetes, or repeated drainage of pleural effusion/pericardial effusion/ abdominal effusion.
13. Pregnant or lactating women.
14. Rapid disease deterioration in the screening process.

Where this trial is running

Guangzhou, Guangdong

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Yilong Wu — Guangdong Provincial People's Hospital
• Study coordinator: Yan Qing

Conditions Small Cell Lung Cancer