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

January 7, 2021 updated by: Yayi He, Shanghai Pulmonary Hospital, Shanghai, China

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  1. Patients with uncertain diagnosis.
  2. Non-central NSCLC patients.
  3. Patients with contraindications to chemotherapy or immunotherapy.
  4. Bronchoscopy is contraindicated in patients.
  5. 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.
  6. Patients with human immunodeficiency virus (HIV) infection.
  7. Patients with infection of active tuberculosis.
  8. 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.
  9. Pregnant or lactating women.
  10. Patients have a known history of psychosophedic substance abuse or drug abuse;
  11. The researchers determined that there may be other factors that might have contributed to the early termination of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Anti-PD-1/PD-L1 Monoclonal Antibody in Combination With Chemotherapy
Drug: Anti-PD-1/PD-L1 Monoclonal Antibody，Chemotherapy
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)
Experimental: Anti-PD-1/PD-L1 Antibody, Chemotherapy, and Bronchoscopy-assisted Interventional Therapy
Drug: Anti-PD-1/PD-L1 Monoclonal Antibody，Chemotherapy
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)
Device: Bronchoscopy-assisted Interventional Therapy
Bronchoscopy-assisted interventional therapy (1 time before chemotherapy or 2 times before chemotherapy and before the third cycle of treatment)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate (ORR)
Time Frame: 6 weeks
To evaluate the objective response rate (ORR) in the first-line treatment of patients with advanced central NSCLC
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease control rate (DCR)
Time Frame: 6 weeks
To evaluate the disease control rate (DCR) in the first-line treatment of patients with advanced central NSCLC
6 weeks
progression free survival (PFS)
Time Frame: 1 year
To evaluate the progression free survival (PFS) in the first-line treatment of patients with advanced central NSCLC
1 year
overall survival (OS)
Time Frame: 2 years
To evaluate the overall survival (OS) in the first-line treatment of patients with advanced central NSCLC
2 years
Number of participants with treatment-related adverse events (AE) as assessed by CTCAE v4.0
Time Frame: 2 years
To evaluate the side effects in the first-line treatment of patients with advanced central NSCLC
2 years
quality of life (QoL)
Time Frame: 2 years
To evaluate the quality of life (QoL) in the first-line treatment of patients with advanced central NSCLC
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 20, 2021

Primary Completion (Anticipated)

March 31, 2022

Study Completion (Anticipated)

January 20, 2026

Study Registration Dates

First Submitted

January 7, 2021

First Submitted That Met QC Criteria

January 7, 2021

First Posted (Actual)

January 8, 2021

Study Record Updates

Last Update Posted (Actual)

January 8, 2021

Last Update Submitted That Met QC Criteria

January 7, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021HY017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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