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

Hengrui Medicine

Status and phase: Completed; Phase 2

Conditions: Small-cell Lung Cancer

Treatments: Drug: SHR-1210; Drug: Apatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03417895

SHR-1210-II-206

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 3 patient groups

A (SHR-1210+Apatinib)

Experimental group

Description:

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

Treatment:

Drug: Apatinib

Drug: SHR-1210

B (SHR-1210+Apatinib)

Experimental group

Description:

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

Treatment:

Drug: Apatinib

Drug: SHR-1210

C (SHR-1210+Apatinib)

Experimental group

Description:

SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD (7 Days on, 7 Days off)

Treatment:

Drug: Apatinib

Drug: SHR-1210