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

NCT ID: NCT05965102

Last Updated: 2023-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tirelizumab in combination with chemotherapy monotherapy

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

Group Type EXPERIMENTAL

Tirelizumab；Chemotherapy monotherapy

Intervention Type DRUG

Tirelizumab combined with chemotherapy in first-line treatment of relapsed/metastatic non-small cell lung cancer with ECOG PS score of 2

Interventions

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Tirelizumab；Chemotherapy monotherapy

Tirelizumab combined with chemotherapy in first-line treatment of relapsed/metastatic non-small cell lung cancer with ECOG PS score of 2

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Jingqi Chen, MD

Role: CONTACT

Phone: 18928787238

Email: [email protected]

References

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Novello S, Le Chevalier T. Chemotherapy for non-small-cell lung cancer. Part 1: Early-stage disease. Oncology (Williston Park). 2003 Mar;17(3):357-64.

Reference Type BACKGROUND
PMID: 12661267 (View on PubMed)

Langer CJ, Besse B, Gualberto A, Brambilla E, Soria JC. The evolving role of histology in the management of advanced non-small-cell lung cancer. J Clin Oncol. 2010 Dec 20;28(36):5311-20. doi: 10.1200/JCO.2010.28.8126. Epub 2010 Nov 15.

Reference Type BACKGROUND
PMID: 21079145 (View on PubMed)

Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH; Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):92-8. doi: 10.1056/NEJMoa011954.

Reference Type BACKGROUND
PMID: 11784875 (View on PubMed)

Reck M, Rodriguez-Abreu D, Robinson AG, Hui R, Csoszi T, Fulop A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leal TA, Riess JW, Jensen E, Zhao B, Pietanza MC, Brahmer JR. Five-Year Outcomes With Pembrolizumab Versus Chemotherapy for Metastatic Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score >/= 50. J Clin Oncol. 2021 Jul 20;39(21):2339-2349. doi: 10.1200/JCO.21.00174. Epub 2021 Apr 19.

Reference Type BACKGROUND
PMID: 33872070 (View on PubMed)

Zhou C, Chen G, Huang Y, Zhou J, Lin L, Feng J, Wang Z, Shu Y, Shi J, Hu Y, Wang Q, Cheng Y, Wu F, Chen J, Lin X, Wang Y, Huang J, Cui J, Cao L, Liu Y, Zhang Y, Pan Y, Zhao J, Wang L, Chang J, Chen Q, Ren X, Zhang W, Fan Y, He Z, Fang J, Gu K, Dong X, Zhang T, Shi W, Zou J; CameL Study Group. Camrelizumab plus carboplatin and pemetrexed versus chemotherapy alone in chemotherapy-naive patients with advanced non-squamous non-small-cell lung cancer (CameL): a randomised, open-label, multicentre, phase 3 trial. Lancet Respir Med. 2021 Mar;9(3):305-314. doi: 10.1016/S2213-2600(20)30365-9. Epub 2020 Dec 18.

Reference Type BACKGROUND
PMID: 33347829 (View on PubMed)

Middleton G, Brock K, Savage J, Mant R, Summers Y, Connibear J, Shah R, Ottensmeier C, Shaw P, Lee SM, Popat S, Barrie C, Barone G, Billingham L. Pembrolizumab in patients with non-small-cell lung cancer of performance status 2 (PePS2): a single arm, phase 2 trial. Lancet Respir Med. 2020 Sep;8(9):895-904. doi: 10.1016/S2213-2600(20)30033-3. Epub 2020 Mar 19.

Reference Type BACKGROUND
PMID: 32199466 (View on PubMed)

Other Identifiers

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2022-LCYJ-ZF-10

Identifier Type: -

Identifier Source: org_study_id