Teniposide after prior therapy for c-Myc–driven extensive-stage small cell lung cancer

Phase II Clinical Study to Evaluate the Efficacy and Safety of Teniposide as a Post-Line Therapy for c-Myc-Driven Extensive-Stage Small Cell Lung Cancer

This will try teniposide in people with extensive-stage small cell lung cancer driven by high c-Myc who have progressed after standard treatment.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06758700 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study gives teniposide to adults (18–75) with extensive-stage small cell lung cancer who have progressed after at least one prior chemotherapy and whose tumors show c-Myc/FBXW2 high expression. Eligible patients must have measurable disease, ECOG performance status 0–1, and an expected survival of at least three months. Participants will receive scheduled teniposide dosing with regular safety checks and tumor response assessments. The trial will record response rates, progression-free survival, adverse events, and explore whether FBXW2/MYC expression levels correlate with treatment benefit.

Who should consider this trial

Good fit: Adults aged 18–75 with extensive-stage SCLC who progressed after at least one chemotherapy, have measurable disease, ECOG 0–1, expected survival ≥3 months, and tumors identified as c-Myc–driven/FBXW2/MYC high expression are ideal candidates.

Not a fit: Patients without measurable lesions, without c-Myc/FBXW2/MYC overexpression, with severe organ dysfunction or poor performance status, or who are pregnant or breastfeeding are unlikely to receive benefit.

Why it matters

Potential benefit: If successful, this approach could provide a biomarker-selected treatment option that improves disease control for patients with c-Myc–driven ES-SCLC after standard therapies fail.

How similar studies have performed: Teniposide and other topoisomerase II inhibitors have historical use in SCLC, but selecting patients by c-Myc/FBXW2 status is a newer strategy with largely preclinical support and limited clinical proof to date.

Eligibility criteria

Inclusion Criteria:

1. extensive stage small cell lung cancer
2. Progression after receiving at least one chemotherapy drug treatment in the past;
3. ECOG score 0-1
4. c-Myc-driven
5. Expected survival period ≥3 months
6. Age: 18-75 years old;
7. The informed consent form complies with the ICH-GCP principles.

Exclusion Criteria:

1. No measurable lesions
2. Other severe and persistent diseases or organ system dysfunction;
3. Women planning pregnancy or men planning family planning;
4. Women who are pregnant or breastfeeding;
5. Those who cannot follow the research protocol provided by the investigator.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Pulmonary Hospital, Shanghai, China — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: jiale Wang

Conditions: Extensive-stage Small Cell Lung Cancer, Thoracic Neoplasms, Lung Neoplasms, Lung Diseases, c-Myc, SCLC, Phase II, Post-line