Combining IBI-322 and Lenvatinib for Advanced Small Cell Lung Cancer

Efficacy and Biomarker Explanation of IBI-322 Plus Lenvatinib on Extensive Stage Small Cell Lung Cancer Who Failed From First Line PD-(L)-1 Inhibitors: Multiple Cohorts Perspective Study

This study is testing whether a new treatment combining IBI-322 and Lenvatinib can help adults with advanced small cell lung cancer who haven't responded to previous therapies.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hunan Province Tumor Hospital (Academic / other)
• Drugs / interventions: chemotherapy, radiation, Lenvatinib
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT05296603 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of IBI-322 in combination with Lenvatinib for patients with extensive stage small cell lung cancer (SCLC) who have not responded to first-line PD-(L)1 inhibitors. The trial aims to evaluate both the treatment's efficacy and the underlying biomarkers that may explain its effects. Eligible participants must be adults aged 18 to 75 with measurable lesions and an ECOG performance status of 0-1. The study will assess the outcomes based on imaging responses and overall survival.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with extensive stage SCLC who have not responded to prior PD-(L)1 inhibitor therapy.

Not a fit: Patients who have not been diagnosed with extensive stage SCLC or those who have not received prior PD-(L)1 inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could provide a new therapeutic option for patients with advanced small cell lung cancer who have limited treatment alternatives.

How similar studies have performed: While this approach is exploring a novel combination, similar studies have shown promise in targeting advanced lung cancer, indicating potential for success.

Eligibility criteria

* Eligible subjects selected for this study must meet all of the following criteria:

  1. Sign written informed consent before implementing any trial-related procedures;
  2. Age ≥18 years old and ≤75 years old;
  3. No limit on the gender;
  4. Patients with extensive stage SCLC diagnosed by pathology (as staged by the American Veterans Lung Cancer Association (VALG)), who do not have an imaging response during first-line treatment with PD-(L)1 inhibitors, or who progress after imaging reactions on first-line therapy (the most recent regimen prior to enrollment must contain PD-(L)1 inhibitors);
  5. According to the Response Evaluation Criteria for Solid Tumors (RECIST V1.1), there must be at least one lesion that can be measured by imaging. Lesions located within the radiation field of previous radiation therapy can be considered as measurable lesions if progress is confirmed;
  6. ECOG score 0-1 points;
  7. Expected survival time\> 3 months;
  8. Sufficient organ function, subjects need to meet the following laboratory indicators:

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  1. The absolute value of neutrophils (ANC) ≥1.5x109/L when no granulocyte colony-stimulating factor is used in the past 14 days;
  2. In the case of no blood transfusion in the past 14 days, platelets ≥100×109/L;
  3. In the past 14 days without blood transfusion or erythropoietin, hemoglobin\>9g/dL;
  4. Total bilirubin≤1.5×upper limit of normal (ULN);
  5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) within ≤2.5×ULN (subjects with liver metastases are allowed to have ALT or AST ≤5×ULN);
  6. Serum creatinine ≤1.5×ULN and creatinine clearance rate (calculated by Cockcroft-Gault formula) ≥50ml/min;
  7. Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 times ULN;
  8. Normal thyroid function is defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH is out of the normal range, subjects whose total T3 (or FT3) and FT4 are within the normal range can also be included in the group;
  9. Myocardial enzyme spectrum is within the normal range (for example, simple laboratory abnormalities that are judged by the investigator to be of no clinical significance are also allowed to be included in the group).

Exclusion Criteria:

* Patients with contraindication of chemotherapy Pregnant or breast feeding women

Where this trial is running

Changsha, Hunan

• Hunan Cancer hospital — Changsha, Hunan, China (Recruiting)

Study contacts

• Study coordinator: Yongchang C Zhang, MD

Conditions Small Cell Lung Cancer