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

NCT05965102 | Unknown Phase 1

• 1 other identifier: 2022-LCYJ-ZF-10
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Proportion of subjects assessed with CR or PR based on RECIST v1.1 criteria as a percentage of all enrolled patients

  Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.

Secondary Outcomes (3)

• Disease control rate

  Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.

• Progression-free survival time

  Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.

• Overall survival time

  Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.

Study Arms (1)

Tirelizumab in combination with chemotherapy monotherapy

EXPERIMENTAL

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

Drug: Tirelizumab；Chemotherapy monotherapy

Interventions

Tirelizumab；Chemotherapy monotherapy DRUG

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

Tirelizumab in combination with chemotherapy monotherapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The age range is between 18 and 85.
• Predicted survival ≥12 weeks.

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead

Related Publications (6)

• 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.

  PMID: 12661267 BACKGROUND

• 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.

  PMID: 21079145 BACKGROUND

• 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.

  PMID: 11784875 BACKGROUND

• 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.

  PMID: 33872070 BACKGROUND

• 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.

  PMID: 33347829 BACKGROUND

• 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.

  PMID: 32199466 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jingqi Chen, MD

CONTACT

18928787238; chenjingqi2002@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2023
• First Posted: July 28, 2023
• Study Start: August 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share