SKB500 Combinations in Patients With 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

SKB500 Combinations in Patients With Small Cell Lung Cancer (NCT07296809) is a Phase 2 interventional studying Small Cell Lung Cancer, sponsored by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Small Cell Lung Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 80 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Small Cell Lung Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Male or female participants between 18 and 75 years old. 2. diagnosed by tissue sample (biopsy-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 previous cancer treatment that works throughout the body (like chemotherapy) 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 willing to sign a consent form form, and can comply with the protocol-specified visits and procedures. Who Should NOT Join This Trial: 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 cancer that has spread to the brain. 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

SKB500 Powder for Injection

SKB500 will be administered as an intravenous (IV) infusion, every 3 weeks on Day 1 of each 21-day cycle and the dose will be determined based on the efficacy and safety data from the SKB500-I-01 study.

DRUG

KL-A167 Injection

KL-A167 will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (1200mg)

DRUG

Carboplatin Injection

Carboplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle（AUC 5, Cycles 1-4)

DRUG

Etoposide Injection

Etoposide will be administered as an intravenous (IV) infusion every 3 weeks on Day 1, 2, and 3 of each 21-day cycle (100 mg/m\^2, Cycles 1-4).

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07296809), the sponsor (Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07296809 clinical trial studying?

The purpose of this study is to assess the safety, tolerability and preliminary antitumor activity of SKB500 combinations in patients with small cell lung cancer. The study is divided into two parts. Part 1 will be the safety run-in phase, and Part 2 will be the cohort expansion phase. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07296809?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07296809?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07296809. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07296809. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.