A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Hypofraction Radiotherapy in Patients With NSCLC

• Sponsor: Shandong Cancer Hospital and Institute (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03557411
• Collaborator: Jiangsu HengRui Medicine Co., Ltd. (Industry)
• Enrollment: 42
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

This is a phase II clinical trial of SHR-1210 （an anti-PD-1 Inhibitor） simultaneously combined with hypofraction radiotherapy in patients with previously treated oligometastatic NSCLC.

It is a single center, single arm, open label trial. Subjects with oligometastatic non-small-cell lung cancer who is previously treated will be recruited. 12 subjects will be enrolled at the first part of the study which aims to evaluate the tolerability of SHR-1210 in combination with hypofraction radiotherapy. 30 subjects will be enrolled at the second part of the study which aims to evaluate the primary efficacy and safety of SHR-1210 in combination with hypofraction radiotherapy.

Condition or Disease	Intervention/Treatment	Phase
Non-Small-Cell Lung Cancer	Drug: SHR-1210	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 42 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: SHR-1210 Simultaneously Combined with Hypofraction RadiotherapySHR-1210 Simultaneously Combined with Hypofraction Radiotherapy
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Clinical Trial of SHR-1210 （an Anti-PD-1 Inhibitor） Simultaneously Combined With Hypofraction Radiotherapy in Patients With Previously Treated Oligometastatic NSCLC
• Actual Study Start Date: Jul 9, 2018
• Anticipated Primary Completion Date: Jul 9, 2020
• Anticipated Study Completion Date: Jul 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SHR-1210 +Hypofraction radiotherapy SHR-1210 （an Anti-PD-1 Inhibitor） Simultaneously Combined with Hypofraction Radiotherapy	Drug: SHR-1210; SHR-1210 （an Anti-PD-1 Inhibitor） Simultaneously Combined with Hypofraction Radiotherapy; Other Names: Hypofraction Radiotherapy

Outcome Measures

Primary Outcome Measures

1. Clinically significant toxicity [First cycle (28 days)]

   above grade 3 AEs

2. 6-month-PFS [From the start of treatment to 6 months.]

   6-month-progression free survival rate

Secondary Outcome Measures

1. AEs+SAEs [from the first drug administration to within 30 days for the last SHR-1210 dose]

   Adverse Events and Serious Adverse Events

2. PFS [up to 2 years]

   Progression-Free-Survival

3. ORR [At baseline,at the time point of every 8 weeks]

   Objective Response Rate

4. DCR [at the time point of every 8 weeks]

   Disease Control Rate

5. OS [up to 2 years]

   OS is the time interval from the start of treatment to death due to any reason or lost of follow-up

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects will voluntarily participate in this study and sign informed consent.

• NSCLC subject with 1 to 5 distant metastatic lesions in stage IV.

• No clear driven genes (including but not limited to EGFR, ALK).

• Previously received more than 1 chemotherapy regimen and progressed/recurred.

• At least one lesion is suitable for hypofraction radiotherapy.

• There is at least one measurable lesion.

• 18 to 75 years old

• ECOG 0-1

• The function of vital organs meets the following requirements. ANC≥1.5×10^{9/L, PLT≥100×10}9/L, Hb≥9g/dL, ALB≥3g/dL, TSH ≤ULN, Bilirubin ≤ 1 times ULN; ALT and AST ≤1.5 times ULN. AKP ≤ 2.5 times ULN. CREA ≤1.5 times ULN or CCr≥60mL/min。

• The estimated survival period is more than 3 months.

• Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment.

Exclusion Criteria:

• The subjects had any history of autoimmune disease or active autoimmune disease.

• Subjects are using immunosuppressive agents, or systemic, or absorptive, local hormone therapy to achieve immunosuppression.It is still in use within 2 weeks of the entry.

• Subjects with severe allergic reactions to other monoclonal antibodies.

• The subjects had a central nervous system metastases of clinical symptoms.

• Central squamous cell lung carcinoma.

• Imaging (CT or MRI) shows that tumors invade large blood vessels or are indistinct with blood vessels.

• Imaging (CT or MRI) showed significant pulmonary vacuity or necrotic tumors,Borderline adenocarcinoma accompanied by a cavity can be considered after discussion with investigator.

• Failing to properly control the clinical symptoms or disease of the heart.

• Subjects had active infections.

• Subjects may receive other systemic antitumor therapy during the study period.

• Other clinical trials of drugs were used in the first four weeks of the first medication.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shandong Cancer Hospital and Institute	Jinan	Shandong	China	250117

Sponsors and Collaborators

• Shandong Cancer Hospital and Institute
• Jiangsu HengRui Medicine Co., Ltd.

Investigators

• Principal Investigator: JINGMIN YU, PhD, Shandong Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jinming Yu, Director of the hospital, Shandong Cancer Hospital and Institute
• ClinicalTrials.gov Identifier: NCT03557411
• Other Study ID Numbers: SHR-1210-RT-IIT-NSCLC-01
• First Posted: Jun 15, 2018
• Last Update Posted: Feb 5, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jinming Yu, Director of the hospital, Shandong Cancer Hospital and Institute: SHR-1210,radiotherapy,Oligometastases,NSCLC
• Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Feb 5, 2020