Overview
A Trial of SHR1701 Combined With Radiotherapy for Metastatic Non-small Cell Lung Cancer Failure After First-line Treatment
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2022-12-01
2022-12-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Shandong Cancer Hospital and Institute
Criteria
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.