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

Shandong First Medical University

Status and phase

Unknown

Phase 2

Conditions

Non-Small-Cell Lung Cancer

Treatments

Drug: SHR1701

Study type

Interventional

Funder types

Other

Identifiers

NCT04560244

NSCLC-2nd-IIT-SHR1701-RT

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.
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.