Clinical trial NCT04560244: A Trial of SHR1701 Combined With Radiotherapy for Metastatic Non-small Cell Lung Cancer Failure After First-line Treatment
Official title: Director of Shandong Cancer Hospital and Institute
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-Small-Cell Lung Cancer
Keywords: SHR1701,radiotherapy,NSCLC
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of participants experiencing adverse event (AE)
timeFrame: From the first administration of shr-1701 to 90 days after the last Administration
measure: Number of participants experiencing serious adverse event (SAE)
timeFrame: From the first administration of shr-1701 to 90 days after the last Administration
Secondary outcomes:
measure: progression-free survival （PFS）
timeFrame: Up to approximately 24 months
measure: Objective Response Rate （ORR）
timeFrame: Up to approximately 24 months
measure: Disease control rate (DCR)
timeFrame: Up to approximately 24 months
measure: Overall survival (OS)
timeFrame: Up to approximately 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: JinMing Yu, PhD
role: PRINCIPAL_INVESTIGATOR
References: