Back to results

Efficacy and Safety of First-line Anti-PD-1/PD-L1 Monoclonal Antibody in Combination With Chemotherapy and Bronchoscopy-assisted Interventional Therapy in Patients With Advanced Central Non-small Cell Lung Cancer

Primary Purpose

Advanced Lung Carcinoma, Non-small Cell Lung Cancer

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Anti-PD-1/PD-L1 Monoclonal Antibody，Chemotherapy

Bronchoscopy-assisted Interventional Therapy

About this trial

This is an interventional treatment trial for Advanced Lung Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1) Patients volunteer to participate in clinical studies and sign an informed consent (ICF), and are willing to follow and able to complete all trial procedures.

2)18-75 years of age 3) All patients included are diagnosed with lung cancer detected by fibrous bronchoscope or percutaneous lung puncture biopsy, and are confirmed as NSCLC by Immunohistochemistry.

4) Obstruction-type central lung cancer that cannot be surgically removed. 5) Patients without EGFR, ALK, and ROS mutation. 6) Patients have not previously received systemic treatment for phase IV NSCLC or patients receiving the adjuvant or neoadjuvant therapy for more than 6 months before the diagnosis of phase IV NSCLC.

7) Within 4 weeks, at least one measurable lesions are required for researchers to evaluate in accordance with RECIST 1.1 requirements.

8) Appropriate tumor tissues for PD-L1 expression level determination are required.

9) Relevant laboratory tests indicate tolerance for chemotherapy, immunotherapy, and bronchoscopy.

Exclusion Criteria:

Patients with uncertain diagnosis.
Non-central NSCLC patients.
Patients with contraindications to chemotherapy or immunotherapy.
Bronchoscopy is contraindicated in patients.
Patients have other active malignancies. Patients with cured limited tumors, such as skin substrate cell carcinoma, skin squamous cancer, superficial bladder cancer, carcinoma in situ of prostate, carcinoma in situ of cervix, and breast in-place cancer, can be included.
Patients with human immunodeficiency virus (HIV) infection.
Patients with infection of active tuberculosis.
Patients have received a live vaccines within 28 days of the first drug use. Patients receiving inactivated viral vaccines to treat seasonal influenza are allowed, but inactivated live influenza vaccines with intracn nasal drugs are not allowed.
Pregnant or lactating women.
Patients have a known history of psychosophedic substance abuse or drug abuse;
The researchers determined that there may be other factors that might have contributed to the early termination of the study.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Anti-PD-1/PD-L1 Monoclonal Antibody in Combination With Chemotherapy

Anti-PD-1/PD-L1 Antibody, Chemotherapy, and Bronchoscopy-assisted Interventional Therapy

Arm Description

Anti-PD-1/PD-L1 Monoclonal Antibody in Combination With Chemotherapy

Anti-PD-1/PD-L1 Antibody, Chemotherapy, and Bronchoscopy-assisted Interventional Therapy

Outcomes

Primary Outcome Measures

objective response rate (ORR)

To evaluate the objective response rate (ORR) in the first-line treatment of patients with advanced central NSCLC

Secondary Outcome Measures

disease control rate (DCR)

To evaluate the disease control rate (DCR) in the first-line treatment of patients with advanced central NSCLC

progression free survival (PFS)

To evaluate the progression free survival (PFS) in the first-line treatment of patients with advanced central NSCLC

overall survival (OS)

To evaluate the overall survival (OS) in the first-line treatment of patients with advanced central NSCLC

Number of participants with treatment-related adverse events (AE) as assessed by CTCAE v4.0

To evaluate the side effects in the first-line treatment of patients with advanced central NSCLC

quality of life (QoL)

To evaluate the quality of life (QoL) in the first-line treatment of patients with advanced central NSCLC

Full Information

NCT ID

NCT04702009

First Posted

January 7, 2021

Last Updated

January 7, 2021

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

1. Study Identification

Unique Protocol Identification Number

NCT04702009

Brief Title

Efficacy and Safety of First-line Anti-PD-1/PD-L1 Monoclonal Antibody in Combination With Chemotherapy and Bronchoscopy-assisted Interventional Therapy in Patients With Advanced Central Non-small Cell Lung Cancer

Official Title

Efficacy and Safety of First-line Anti-PD-1/PD-L1 Monoclonal Antibody in Combination With Chemotherapy vs. Anti-PD-1/PD-L1 Monoclonal Antibody, Chemotherapy, in Combination With Bronchoscopy-assisted Interventional Therapy in the Treatment of Patients With Advanced Central Non-small Cell Lung Cancer, a Randomized Controlled, Prospective Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 20, 2021 (Anticipated)

Primary Completion Date

March 31, 2022 (Anticipated)

Study Completion Date

January 20, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

Lung cancer is one of the malignant tumors with high morbidity and mortality. Several PD-1/PD-L1 immune checkpoint inhibitors have been approved for the treatment of advanced non-small cell lung cancer (NSCLC). However, its overall effective population is only 20%, and even in studies of enriched populations (such as PD-L1 ≥ 50%), its single-drug effective rate is only about 40%. Therefore, this study aims to explore the efficacy and safety of anti-PD-1/PD-L1 monoclonal antibodies and chemotherapy in combination with bronchoscopy-assisted lnterventional therapy in the first-line treatment of advanced central non-small cell lung cancer. We conducted a randomized controlled, prospective clinical trial to examine the efficacy, safety, and mechanism of anti-PD-1/PD-L1 monoclonal antibodies, chemotherapy, in combination with bronchoscopy-assisted interventional therapy vs anti-PD-1/PD-L1 monoclonal antibody in combination with chemotherapy as the first-line treatment of patients with advanced central NSCLC.

Detailed Description

Lung cancer is one of the malignant tumors with high morbidity and mortality. Most patients with lung cancers are already in advanced stages when diagnosed, and the 5-year survival rate of advanced lung cancer is less than 5%. Therefore, exploring effective treatments is of great significance for improving the survival and quality of life of patients with lung cancer. Immunotherapy represented by immune checkpoint inhibitors has received widespread attention in the field of lung cancer, and several PD-1/PD-L1 immune checkpoint inhibitors have been approved for the treatment of advanced non-small cell lung cancer (NSCLC).However, its overall effective population is only 20%, even in studies of enriched populations (such as PD-L1 ≥ 50%), its single-drug effective rate is only about 40%. Therefore, this study aims to explore the efficacy and safety of anti-PD-1/PD-L1 monoclonal antibodies and chemotherapy in combination with bronchoscopy-assisted interventional therapy in the first-line treatment of advanced central non-small cell lung cancer. We conducted a randomized controlled, prospective clinical trial to examine the efficacy, safety and mechanism of anti-PD-1/PD-L1 monoclonal antibodies and chemotherapy in combination with bronchoscopy-assisted interventional therapy versus anti-PD-1/PD-L1 monoclonal antibody in combination with chemotherapy as the first-line treatment of patients with advanced central NSCLC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Lung Carcinoma, Non-small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Anti-PD-1/PD-L1 Monoclonal Antibody in Combination With Chemotherapy

Arm Type

Active Comparator

Arm Description

Anti-PD-1/PD-L1 Monoclonal Antibody in Combination With Chemotherapy

Arm Title

Anti-PD-1/PD-L1 Antibody, Chemotherapy, and Bronchoscopy-assisted Interventional Therapy

Arm Type

Experimental

Arm Description

Anti-PD-1/PD-L1 Antibody, Chemotherapy, and Bronchoscopy-assisted Interventional Therapy

Intervention Type

Drug

Intervention Name(s)

Anti-PD-1/PD-L1 Monoclonal Antibody，Chemotherapy

Intervention Description

Anti-PD-1/PD-L1 monoclonal antibody (approved anti-PD-1/PD-L1 monoclonal antibody)；albumin paclitaxel/docetaxel + carboplatin (albumin paclitaxel 130mg/m2, d1 d8, Docetaxel 75mg/m2, carboplatin AUC=5, d1, every 21 days, 4 cycles of chemotherapy; immunotherapy no more than 2 years)

Intervention Type

Device

Intervention Name(s)

Bronchoscopy-assisted Interventional Therapy

Intervention Description

Bronchoscopy-assisted interventional therapy (1 time before chemotherapy or 2 times before chemotherapy and before the third cycle of treatment)

Primary Outcome Measure Information:

Title

objective response rate (ORR)

Description

To evaluate the objective response rate (ORR) in the first-line treatment of patients with advanced central NSCLC

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

disease control rate (DCR)

Description

To evaluate the disease control rate (DCR) in the first-line treatment of patients with advanced central NSCLC

Time Frame

6 weeks

Title

progression free survival (PFS)

Description

To evaluate the progression free survival (PFS) in the first-line treatment of patients with advanced central NSCLC

Time Frame

1 year

Title

overall survival (OS)

Description

To evaluate the overall survival (OS) in the first-line treatment of patients with advanced central NSCLC

Time Frame

2 years

Title

Number of participants with treatment-related adverse events (AE) as assessed by CTCAE v4.0

Description

To evaluate the side effects in the first-line treatment of patients with advanced central NSCLC

Time Frame

2 years

Title

quality of life (QoL)

Description

To evaluate the quality of life (QoL) in the first-line treatment of patients with advanced central NSCLC

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1) Patients volunteer to participate in clinical studies and sign an informed consent (ICF), and are willing to follow and able to complete all trial procedures. 2)18-75 years of age 3) All patients included are diagnosed with lung cancer detected by fibrous bronchoscope or percutaneous lung puncture biopsy, and are confirmed as NSCLC by Immunohistochemistry. 4) Obstruction-type central lung cancer that cannot be surgically removed. 5) Patients without EGFR, ALK, and ROS mutation. 6) Patients have not previously received systemic treatment for phase IV NSCLC or patients receiving the adjuvant or neoadjuvant therapy for more than 6 months before the diagnosis of phase IV NSCLC. 7) Within 4 weeks, at least one measurable lesions are required for researchers to evaluate in accordance with RECIST 1.1 requirements. 8) Appropriate tumor tissues for PD-L1 expression level determination are required. 9) Relevant laboratory tests indicate tolerance for chemotherapy, immunotherapy, and bronchoscopy. Exclusion Criteria: Patients with uncertain diagnosis. Non-central NSCLC patients. Patients with contraindications to chemotherapy or immunotherapy. Bronchoscopy is contraindicated in patients. Patients have other active malignancies. Patients with cured limited tumors, such as skin substrate cell carcinoma, skin squamous cancer, superficial bladder cancer, carcinoma in situ of prostate, carcinoma in situ of cervix, and breast in-place cancer, can be included. Patients with human immunodeficiency virus (HIV) infection. Patients with infection of active tuberculosis. Patients have received a live vaccines within 28 days of the first drug use. Patients receiving inactivated viral vaccines to treat seasonal influenza are allowed, but inactivated live influenza vaccines with intracn nasal drugs are not allowed. Pregnant or lactating women. Patients have a known history of psychosophedic substance abuse or drug abuse; The researchers determined that there may be other factors that might have contributed to the early termination of the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yayi He, ph.D, MD

Phone

+86-21-65115006

Ext

3056

doctorjael@foxmail.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31912902

Citation

Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.

Results Reference

background

PubMed Identifier

29191604

Citation

He Y, Rozeboom L, Rivard CJ, Ellison K, Dziadziuszko R, Yu H, Zhou C, Hirsch FR. MHC class II expression in lung cancer. Lung Cancer. 2017 Oct;112:75-80. doi: 10.1016/j.lungcan.2017.07.030. Epub 2017 Jul 29.

Results Reference

background

PubMed Identifier

28275222

Citation

He Y, Rozeboom L, Rivard CJ, Ellison K, Dziadziuszko R, Yu H, Zhou C, Hirsch FR. PD-1, PD-L1 Protein Expression in Non-Small Cell Lung Cancer and Their Relationship with Tumor-Infiltrating Lymphocytes. Med Sci Monit. 2017 Mar 9;23:1208-1216. doi: 10.12659/msm.899909.

Results Reference

background

PubMed Identifier

31564917

Citation

Deng J, Zhao S, Zhang X, Jia K, Wang H, Zhou C, He Y. OX40 (CD134) and OX40 ligand, important immune checkpoints in cancer. Onco Targets Ther. 2019 Sep 6;12:7347-7353. doi: 10.2147/OTT.S214211. eCollection 2019.

Results Reference

background

PubMed Identifier

28132868

Citation

He Y, Yu H, Rozeboom L, Rivard CJ, Ellison K, Dziadziuszko R, Suda K, Ren S, Wu C, Hou L, Zhou C, Hirsch FR. LAG-3 Protein Expression in Non-Small Cell Lung Cancer and Its Relationship with PD-1/PD-L1 and Tumor-Infiltrating Lymphocytes. J Thorac Oncol. 2017 May;12(5):814-823. doi: 10.1016/j.jtho.2017.01.019. Epub 2017 Jan 26.

Results Reference

background

PubMed Identifier

31454748

Citation

He Y, Jia K, Dziadziuszko R, Zhao S, Zhang X, Deng J, Wang H, Hirsch FR, Zhou C. Galectin-9 in non-small cell lung cancer. Lung Cancer. 2019 Oct;136:80-85. doi: 10.1016/j.lungcan.2019.08.014. Epub 2019 Aug 16.

Results Reference

background

Learn more about this trial

We'll reach out to this number within 24 hrs