Tirellizumab Combined With Chemotherapy Monotherapy for Non-small Cell Lung Cancer

Second Affiliated Hospital of Guangzhou Medical University

Status and phase: Not yet enrolling; Phase 1

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Tirelizumab；Chemotherapy monotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05965102

2022-LCYJ-ZF-10

Details and patient eligibility

About

This is a prospective, single-arm, single-center, exploratory clinical trial to evaluate the efficacy and safety of the PD-1 antibody tirelizumab combined with chemotherapy monotherapy in patients with relapsed/metastatic non-small cell lung cancer.

Full description

This is a prospective, single-arm, single-center, exploratory clinical trial to evaluate the efficacy and safety of the PD-1 antibody tirellizumab combined with chemotherapy monotherapy in patients with relapsed/metastatic non-small cell lung cancer. This study prospectively collected disease history, treatment history, demographic data, baseline data during treatment, each treatment visit data, efficacy data, and safety data of NSCLC patients with EGFR and ALK driver negative ECOG PS 2 scores treated with tirellizumab combined with monotherapy. The subjects did not voluntarily withdraw from the test or the researchers believed that the subjects were not suitable for further test. Each subject will be treated until the disease progresses or the toxic and side effects caused by the drugs are intolerable, and the follow-up treatment plan, treatment status and survival data of the patients still need to be collected.

Enrollment: 31 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pathologically confirmed recurrent/metastatic non-small cell lung cancer with local recurrence or distant metastasis after prior radiotherapy and/or surgery, or with distant metastasis at the time of admission.
2. The age range is between 18 and 85.
3. Predicted survival ≥12 weeks.

Exclusion criteria

1. Patients with other malignant tumors.
2. Positive tests for EGFR mutation and ALK fusion gene have been confirmed.
3. Partial comorbidity.
4. other.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Tirelizumab in combination with chemotherapy monotherapy

Experimental group

Description:

This study is a one-arm, exploratory study and does not involve randomization. There was only one trial group of tirellizumab plus chemotherapy monotherapy.

Treatment:

Drug: Tirelizumab；Chemotherapy monotherapy