A Trial of SHR1701 Combined With Radiotherapy for Metastatic Non-small Cell Lung Cancer Failure After First-line Treatment

NCT04560244 | Unknown Phase 2 DMC

• 1 other identifier: NSCLC-2nd-IIT-SHR1701-RT
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a single center, single arm, open study design. The main purpose of this study is to evaluate the tolerance and efficacy of SHR1701 with synchronous radiotherapy in patients with metastatic non-small cell lung cancer who have failed after systematic treatment. Large fraction radiotherapy is given to all lesions as much as possible, and low-dose radiotherapy is given to the lesions that cannot be tolerated or have no obvious benefit.

Conditions

Non-Small-Cell Lung Cancer

Keywords

SHR1701,radiotherapy,NSCLC

Outcome Measures

Primary Outcomes (2)

• Number of participants experiencing adverse event (AE)

  From the first administration of shr-1701 to 90 days after the last Administration

• Number of participants experiencing serious adverse event (SAE)

  From the first administration of shr-1701 to 90 days after the last Administration

Secondary Outcomes (4)

• progression-free survival （PFS）

  Up to approximately 24 months

• Objective Response Rate （ORR）

  Up to approximately 24 months

• Disease control rate (DCR)

  Up to approximately 24 months

• Overall survival (OS)

  Up to approximately 24 months

Study Arms (1)

SHR 1701+radiotherapy

EXPERIMENTAL

SHR-1701 Simultaneously Combined with High Fractionation and Low-dose Radiotherapy

Drug: SHR1701

Interventions

SHR1701 DRUG

PD-L1 / TGF-β RII double antibody

SHR 1701+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 voluntarily participate in this study and sign informed consent.
• NSCLC in stage IV.
• No clear driven genes (including but not limited to EGFR、ALK、ROS1、cMET).
• 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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

SHR-1701

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

• JinMing Yu, PhD

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JinMing Yu, PhD

CONTACT

8613806406293; jn7984729@public.jn.sd.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: President of Shandong Cancer Hospital and Institute

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 23, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 23, 2020

Record last verified: 2020-09