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Trial Title:
Surufatinib Plus Anti-PD-1/L1 as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer
NCT ID:
NCT05509699
Condition:
Extensive-Stage Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Immune Checkpoint Inhibitors
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
The study consists of two parts, i.e., a single-arm Phase IIa study and a randomized
(1:1), controlled Phase IIb study.
Phase IIa:
It is planned that 20 patients will be enrolled to receive treatment with Surufatinib
plus anti-PD-1/L1, the same immune checkpoint inhibitor from patients' first-line therapy
.
Phase IIb:
It is planned that 40 patients will be enrolled to receive the following treatments:
Group A: Patients will receive treatment with Surufatinib plus anti-PD-1/L1, the same
immune checkpoint inhibitor from patients' first-line therapy.
Group B: Patients will receive treatment with anti-PD-1/L1, the same immune checkpoint
inhibitor from patients' first-line therapy.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Surufatinib
Description:
The recommended dosage is 250 mg orally once daily (QD) within 1 hour after breakfast for
continuous administration.
Arm group label:
Surufatinib in combination with anti-PD-1/L1 therapy
Intervention type:
Drug
Intervention name:
Anti-PD-1/L1
Description:
Anti-PD-1/L1 therapy, Q3W or Q4W, the same immune checkpoint inhibitor from patients'
first-line therapy.
Arm group label:
Anti-PD-1/L1 monotherapy
Arm group label:
Surufatinib in combination with anti-PD-1/L1 therapy
Other name:
Immune checkpoint inhibitor
Summary:
This is an open-label, multi-center Phase II study designed to evaluate the efficacy and
safety of Surufatinib plus anti-PD-1/L1 as maintenance therapy after first-line standard
of care in patients with ES-SCLC.
Detailed description:
This study consists of two parts, i.e., a single-arm Phase IIa study and a randomized,
controlled Phase IIb study. All the enrolled patients will be patients with ES-SCLC who
did not have PD (determined as per the RECIST v1.1) after prior platinum-based
chemotherapy in combination with an anti-PD-1/L1. Approximately 20 patients are planned
to be enrolled in the single-arm Phase IIa study to preliminarily observe the efficacy
and safety. Approximately 40 patients are planned to be enrolled in the randomized and
controlled Phase IIb study with 20 patients per group.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients who sufficiently understand this study and is willing to sign the ICF;
2. Aged from 18 to 75 years (inclusive);
3. Patients with histologically or cytologically confirmed ES-SCLC ;
4. Patients who did not have PD (assessed as per the RECIST v1.1) after prior
first-line platinum-based chemotherapy plus an anti-PD-1/L1;
5. Patients with measurable lesions as defined in the RECIST v1.1 ;
6. Life expectancy ≥ 12 weeks;
7. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 1;
8. Adequate organ function:
9. Females of childbearing potential must have a negative serum pregnancy test within 7
days prior to the first dose. Male or female patients of childbearing potential
should be willing to use effective contraceptive methods during the study and within
90 days after last dose of the study drug.
Exclusion Criteria:
1. Previous use of anti-vascular endothelial growth factor (VEGF) drugs/anti-vascular
endothelial growth factor receptor (VEGFR) agents;
2. Use of systematic anti-tumor therapies other than first-line platinum-based
chemotherapy in combination with anti-PD-1/L1 within 4 weeks prior to the first
dose;
3. Presence of central nervous system (CNS) metastasis and/or cancerous meningitis
(metastases to meninges);
4. Toxicities associated with previous anti-tumor treatment that has not been resolved
to CTCAE Grade ≤ 1, except for alopecia and CTCAE Grade ≤ 2 peripheral
neurotoxicity;
5. Uncontrollable malignant hydrothorax, ascites or pericardial effusion;
6. Patients with active autoimmune disorder or immunodeficiency or history of
autoimmune disorder or immunodeficiency;
7. Patients with evidence or history of obvious bleeding tendency within 2 months prior
to the first dose;
8. Clinically significant cardiovascular disorders;
9. Severe infection within 4 weeks prior to the start of study treatment, including but
not limited to hospitalization for infection, bacteraemia or severe pneumonia;
10. Patients who are unable to take oral medications, or with previous surgical history
or severe gastrointestinal;
11. Pregnant (with a positive pregnancy test) or lactating women within 5 years before
screening.
12. Patients with a history of malignant tumors excluding small cell lung cancer (SCLC)
within 5 years before screening.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chinese PLA General Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Yi Hu, Postdoctor
Phone:
86 010 66937003
Email:
huyi0401@aliyun.com
Start date:
September 27, 2022
Completion date:
December 2024
Lead sponsor:
Agency:
Hutchison Medipharma Limited
Agency class:
Industry
Source:
Hutchmed
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05509699
