SHR-1210 Combined With Apatinib in Treatment of ED-SCLC After Failure of First Line Standard Therapy

Small-cell Lung Cancer Clinical Trial

— PASSION  

Official title:

Anti-PD-1 Antibody SHR-1210 Combined With Anti-angiogenesis Inhibitor Apatinib in Treatment of Extensive-stage Disease Small Cell Lung Cancer After Failure of First Line Standard Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03417895
• Other study ID #: SHR-1210-II-206
• Status: Completed
• Phase: Phase 2
• Start date: April 20, 2018
• Est. completion date: August 4, 2021

Study information

• Verified date: February 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-center, open-label, phase II study of intravenous (IV) SHR-1210 at 200mg,q2w in combination with Apatinib at one dose (375mg). Comparison of 3 different dose schedules in subjects with extensive-stage disease small cell lung cancer. SHR-1210 is a humanized monoclonal antibody against Programmed death 1(PD-1). Apatinib is a new kind of selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2) tyrosine kinase inhibitor (TKI).

The study is composed of two parts. Part 1 of the study will determine the safety and tolerability of SHR-1210 in combination with Apatinib in first 6 subjects of each arm. The second phase of treatment was carried out by selecting one group of administration mode and the tolerated dose of Apatinib. Part 2 of the study will determine the safety and efficacy of SHR-1210 in combination with Apatinib in 39 subjects.

Description:

Subjects will be 1:1:1 randomly assigned to receive

• SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD, or

• SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD（5 Days on, 2 Days off）, or

• SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD（7 Days on, 7 Days off） treatment until disease progression, unacceptable toxicity, or death.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: August 4, 2021
• Est. primary completion date: August 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Signed inform consent form

2. Age >= 18 years and <= 70 years

3. Histologically or cytologically confirmed small cell lung cancer

4. ED-SCLC according to Veterans Administration Lung Study Group

5. Radiographically progression following a platinum-based standard prior chemotherapy regimen.

6. Eastern Cooperative Oncology Group performance status of 0 or 1

7. Measurable disease as defined by RECIST v1.1

8. Life expectancy >= 8 weeks

9. Adequate hematologic and end organ function

Exclusion Criteria:

1. Histologically or cytologically confirmed mixed non-small cell and small cell carcinoma

2. Prior exposure to therapeutic anticancer vaccines; prior exposure to any T cell co-stimulatory therapy or immune checkpoint inhibitors, including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-PD-L2 antibodies

3. Prior exposure to anti-VEGF or anti-VEGFR therapy

4. Active brain metastasis or meningeal metastasis.

5. Clinically significant third space effusion (e.g., uncontrolled pericardial effusion, ascites or pleural effusion by extraction or other treatment)

6. Known hypersensitivity to study drug or any of its excipients; known hypersensitivity to any antibody

7. Treatment with any other investigational agent or participation in another clinical trial within 4 weeks prior to screening

8. Other conditions that the investigator thinks unsuitable in this study

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Carcinoma
• Small-cell Lung Cancer

Intervention

Drug:
• SHR-1210
A humanized anti-PD-1 monoclonal antibody
• Apatinib
A tyrosine kinase inhibitor selectively targeting VEGFR-2

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Science	Beijing	Beijing
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event of part 1	• Evaluation of adverse event rate according to CTCAE v4.03	on average of of 3 months(First 6 subjects in each arm)
Primary	ORR	• Objective response rate according to RECIST v1.1	6 months
Secondary	Adverse event	• Evaluation of adverse event rate according to CTCAE v4.03	6 months
Secondary	OS rate	• OS rate	6 months
Secondary	PFS	• Progression-free survival according to RECIST v1.1	6 months
Secondary	TTR	• Time to response according to RECIST v1.1	6 months
Secondary	DoR	• Duration of response according to RECIST v1.1	6 months
Secondary	DCR	• Disease control rate according to RECIST v1.1	6 months
Secondary	OS	• Overall survival	on average of 2 years
Secondary	Immunogenicity	• Positive rate of anti-drug antibody and neutralizing antibody	6 months