Efficacy and Biomarker Explanation of IBI-322 Plus Lenvatinib on Extensive Stage Small Cell Lung Cancer

Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05296603
• Other study ID #: BELIEVE
• Status: Recruiting
• Phase: Phase 2
• Start date: December 3, 2021
• Est. completion date: December 25, 2025

Study information

• Verified date: January 2024
• Source: Hunan Province Tumor Hospital
• Contact: Yongchang C Zhang, MD
• Phone: +8613873123436
• Email: zhangyongchang[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to explore the 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 83
• Est. completion date: December 25, 2025
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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:

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• IBI-322 Plus Lenvatinib
IBI322 is based on the "3+3" model, with a dose ascent starting from 10mg

Locations

Country	Name	City	State
China	Hunan Cancer hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Province Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects	12 weeks
Secondary	PFS	Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)	1year
Secondary	OS	Defined as the time from the start of treatment to the death of the subject due to any cause.	1 year