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

NCT03557411 | Unknown Phase 2

• 1 other identifier: SHR-1210-RT-IIT-NSCLC-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small-Cell Lung Cancer

Keywords

SHR-1210,radiotherapy,Oligometastases,NSCLC

Outcome Measures

Primary Outcomes (2)

• Clinically significant toxicity

  above grade 3 AEs

  First cycle (28 days)

• 6-month-PFS

  6-month-progression free survival rate

  From the start of treatment to 6 months.

Secondary Outcomes (5)

• AEs+SAEs

  from the first drug administration to within 30 days for the last SHR-1210 dose

• PFS

  up to 2 years

• ORR

  At baseline,at the time point of every 8 weeks

• DCR

  at the time point of every 8 weeks

• OS

  up to 2 years

Study Arms (1)

SHR-1210 +Hypofraction radiotherapy

EXPERIMENTAL

SHR-1210 （an Anti-PD-1 Inhibitor） Simultaneously Combined with Hypofraction Radiotherapy

Drug: SHR-1210

Interventions

SHR-1210 DRUG

SHR-1210 （an Anti-PD-1 Inhibitor） Simultaneously Combined with Hypofraction Radiotherapy

Also known as: Hypofraction Radiotherapy

SHR-1210 +Hypofraction radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, 250117, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

camrelizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• JINGMIN YU, PhD

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JINGMIN YU, PhD

CONTACT

8613806406293; jn7984729@public.jn.sd.cn

LIGANG XING, PhD

CONTACT

8618053100188; xinglg@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the hospital

Model Details: SHR-1210 Simultaneously Combined with Hypofraction Radiotherapy

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 15, 2018
• Study Start: July 9, 2018
• Primary Completion: July 9, 2020
• Study Completion: July 9, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

CN (1)