Clinical trial NCT05509699: Surufatinib Plus Anti-PD-1/L1 as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer
Official title: An Open-Label, Multi-Center Phase II Study of Surufatinib Plus Anti-PD-1/L1 as Maintenance Therapy in Patients With Extensive-Stage Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Extensive-Stage Small Cell Lung Cancer
Lead sponsor: Hutchmed
Sponsor class: INDUSTRY
First posted: 2022-08-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.

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.

Primary outcomes:
measure: Progression-free survival
timeFrame: About 18 months
Secondary outcomes:
measure: Overall survival
timeFrame: About 18 months
measure: Objective response rate
timeFrame: About 18 months
measure: Disease control rate
timeFrame: About 18 months
measure: Duration of response
timeFrame: About 18 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
affiliation: Chinese PLA General Hospital
name: Yi Hu, Postdoctor
role: PRINCIPAL_INVESTIGATOR
References: