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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04560244
Other study ID # NSCLC-2nd-IIT-SHR1701-RT
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date September 2020
Est. completion date December 2022

Study information

Verified date September 2020
Source Shandong Cancer Hospital and Institute
Contact JinMing Yu, PhD
Phone 8613806406293
Email jn7984729@public.jn.sd.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 15
Est. completion date December 2022
Est. primary completion date September 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Intervention

Drug:
SHR1701
PD-L1 / TGF-ß RII double antibody

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shandong Cancer Hospital and Institute

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants experiencing adverse event (AE) From the first administration of shr-1701 to 90 days after the last Administration
Primary Number of participants experiencing serious adverse event (SAE) From the first administration of shr-1701 to 90 days after the last Administration
Secondary progression-free survival (PFS) Up to approximately 24 months
Secondary Objective Response Rate (ORR) Up to approximately 24 months
Secondary Disease control rate (DCR) Up to approximately 24 months
Secondary Overall survival (OS) Up to approximately 24 months
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