Non-Small-Cell Lung Cancer
Conditions
Keywords
SHR1701,radiotherapy,NSCLC
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.
Interventions
DRUGSHR1701
PD-L1 / TGF-β RII double antibody
Sponsors
Shandong Cancer Hospital and Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Contacts
Primary ContactJinMing Yu, PhD
Outcome results
None listed