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

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: 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 2
• Accepts Healthy Volunteers?: No

Details

• 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.