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

NCT ID: NCT05296603

Last Updated: 2024-01-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-03
• Study Completion Date: 2025-12-25

Brief 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.

Conditions

Small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A

Duration of response time less than 3 months

Group Type: EXPERIMENTAL

IBI-322 Plus Lenvatinib

Intervention Type: DRUG

IBI322 is based on the "3+3" model, with a dose ascent starting from 10mg

Cohort B

Duration of response time between 3 and 6 months

Group Type: EXPERIMENTAL

IBI-322 Plus Lenvatinib

Intervention Type: DRUG

IBI322 is based on the "3+3" model, with a dose ascent starting from 10mg

Cohort C

Duration of response time more than 6 months

Group Type: EXPERIMENTAL

IBI-322 Plus Lenvatinib

Intervention Type: DRUG

IBI322 is based on the "3+3" model, with a dose ascent starting from 10mg

Interventions

IBI-322 Plus Lenvatinib

IBI322 is based on the "3+3" model, with a dose ascent starting from 10mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hunan Province Tumor Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yongchang Zhang

Director, Head of Medical Oncology, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hunan Cancer hospital

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongchang C Zhang, MD

Role: CONTACT

zhangyongchang@csu.edu.cn

+8613873123436 ext. 7+861383123436

Nong C Yang, MD

Role: CONTACT

yangnong0217@163.com

+8613873123436 ext. +8613873123436

Facility Contacts

Yongchang Zhang, MD

Role: primary

zhangyongchang@csu.edu.cn

+86 731 89762321

Other Identifiers

BELIEVE

Identifier Type: -

Identifier Source: org_study_id