Efficacy and Safety of High-Dose Rate Brachytherapy with Immunotherapy and Chemotherapy As Second-Line Treatment for Advanced Non-Small Cell Lung Cancer (HIBIC-NSCLC)

July 20, 2024 updated by: Ou Jiang, The First People's Hospital of Neijiang

Exploring the Efficacy and Safety of High-Dose Rate Brachytherapy Combined with Immunotherapy and Chemotherapy As a Second-Line Treatment in Patients with Advanced Non-Small Cell Lung Cancer: a Single-Center, Retrospective, Propensity Score-Matched Study

This is a single-center, retrospective, propensity score-matched study exploring the efficacy and safety of high-dose rate (HDR) brachytherapy combined with immune checkpoint inhibitors (ICIs) and chemotherapy as a second-line treatment for advanced non-small cell lung cancer (NSCLC).

The study will compare two groups:

Study group: HDR brachytherapy (30Gy single fraction) + ICIs (pembrolizumab) + chemotherapy (docetaxel) Control group: ICIs (pembrolizumab) + chemotherapy (docetaxel) alone Primary objective: To assess the objective response rate (ORR)

Secondary objectives: To evaluate progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety.

The study aims to address the unmet clinical need for effective treatments in advanced NSCLC patients who have progressed after immunotherapy. It will investigate whether the addition of HDR brachytherapy to immunotherapy and chemotherapy can improve treatment outcomes.

This research is significant as it explores a novel treatment combination, potentially offering new options for second-line treatment of advanced NSCLC. It also aims to contribute to the understanding of how radiotherapy doses affect immunotherapy responses and may help identify biomarkers for treatment response prediction.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Study Title: Exploring the Efficacy and Safety of High-Dose Rate Brachytherapy Combined with Immunotherapy and Chemotherapy as a Second-Line Treatment in Patients with Advanced Non-Small Cell Lung Cancer

Background:

Non-small cell lung cancer (NSCLC) is a significant health concern in China, accounting for approximately 18.1% of new cancer cases in 2022. Despite advancements in targeted therapies and immunotherapies, patients with advanced NSCLC who progress after initial treatment face limited options and poor prognosis. This study aims to address this unmet clinical need by investigating a novel combination therapy.

Objectives:

Primary: To evaluate the objective response rate (ORR) of high-dose rate (HDR) brachytherapy combined with immune checkpoint inhibitors (ICIs) and chemotherapy in advanced NSCLC patients.

Secondary: To assess progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety of the combination therapy.

Study Design:

This is a single-center, retrospective, propensity score-matched study comparing two treatment approaches:

Study group: HDR brachytherapy + ICIs + chemotherapy Control group: ICIs + chemotherapy alone

Treatment Protocol:

Study group: Patients will receive HDR brachytherapy (30Gy single fraction), followed by pembrolizumab and docetaxel chemotherapy within 1-3 days.

Control group: Patients will receive pembrolizumab and docetaxel chemotherapy without brachytherapy.

Key Scientific Questions:

Evaluate the potential improvement in second-line treatment efficacy for advanced NSCLC patients through the combination therapy.

Investigate the mechanisms by which HDR brachytherapy enhances the effectiveness of ICIs and chemotherapy.

Analyze the differential efficacy of the combination therapy across various subgroups of NSCLC patients.

Rationale:

Recent evidence suggests that radiotherapy can exert immunomodulatory effects, potentially enhancing immune treatment responses. High-dose radiotherapy has been shown to improve local control and survival rates in early-stage NSCLC when combined with immunotherapy. This study extends this concept to advanced NSCLC as a second-line treatment option.

Significance:

This research addresses a critical gap in current treatment options for advanced NSCLC patients who have progressed after immunotherapy. It aims to:

Improve patient outcomes in terms of quality of life and survival. Advance scientific understanding of the interaction between radiotherapy and immunotherapy.

Explore potential biomarkers for treatment response prediction. Contribute to the development of more personalized treatment strategies in oncology.

Innovation:

This is the first study to investigate HDR brachytherapy combined with ICIs and chemotherapy for previously treated advanced NSCLC patients. The novel combination strategy shows potential for improved efficacy and safety, offering new options for second-line treatment of advanced NSCLC.

Expected Outcomes:

The study aims to demonstrate improved ORR, PFS, and OS in the combination therapy group compared to the control group. It also seeks to establish the safety profile of the combination therapy and identify patient subgroups that may benefit most from this approach.

Conclusion:

This study represents a significant step towards addressing the unmet needs of advanced NSCLC patients who have progressed after initial treatment. By exploring this innovative combination therapy, the research aims to contribute valuable insights to the field of oncology and potentially improve treatment outcomes for this challenging patient population.

Study Type

Observational

Enrollment (Estimated)

80

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  1. Adult patients with advanced Non-Small Cell Lung Cancer (NSCLC)
  2. Requiring second-line treatment after progression on initial therapy
  3. Likely stage IIIB-IV disease
  4. Measurable disease according to RECIST v1.1 criteria
  5. Without targetable driver mutations (e.g., EGFR, ALK, ROS1, BRAF)
  6. Candidates for immunotherapy and chemotherapy
  7. Adequate organ function to tolerate proposed treatments
  8. ECOG performance status likely 0-2
  9. May have prior exposure to immunotherapy
  10. Treated at a single center in China
  11. Divided into two groups

Description

Inclusion Criteria:

  • Diagnosis of advanced Non-Small Cell Lung Cancer (NSCLC),Likely stage IIIB-IV, though specific staging is not mentioned
  • Patients requiring second-line treatment Implying progression after first-line therapy
  • Age: Adults (specific age range not provided, but typically 18 years or older)
  • Presence of measurable disease according to RECIST v1.1 criteria
  • Adequate organ function (specific parameters not provided, but typically included in such studies)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (not explicitly stated, but common in similar studies)

Exclusion Criteria:

  • Presence of targetable driver mutations (e.g., EGFR, ALK, ROS1, BRAF)
  • Prior treatment with HDR brachytherapy for the current disease
  • Contraindications to immunotherapy or chemotherapy
  • Severe comorbidities that would preclude safe administration of study treatments
  • Brain metastases, unless treated and stable (not explicitly stated, but common in similar studies)
  • Participation in another clinical trial with an investigational agent

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Every 8 weeks from baseline up to 24 months or until disease progression, unacceptable toxicity, or withdrawal from the study, whichever occurs first
The proportion of patients achieving either a complete response (CR) or partial response (PR) according to RECIST v1.1 criteria
Every 8 weeks from baseline up to 24 months or until disease progression, unacceptable toxicity, or withdrawal from the study, whichever occurs first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Progression-Free Survival was assessed from the date of treatment initiation until the date of first documented disease progression or death from any cause, whichever occurred first, assessed up to 24 months.
Time from treatment initiation to disease progression or death from any cause
Progression-Free Survival was assessed from the date of treatment initiation until the date of first documented disease progression or death from any cause, whichever occurred first, assessed up to 24 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Overall Survival was measured from the date of treatment initiation until death from any cause or patients who were still alive at the last follow-up were censored at that time point, assessed up to 36 months.
Time from treatment initiation to death from any cause
Overall Survival was measured from the date of treatment initiation until death from any cause or patients who were still alive at the last follow-up were censored at that time point, assessed up to 36 months.

Collaborators and Investigators

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

Sponsor

The First People's Hospital of Neijiang

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 (Actual)

September 1, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

July 13, 2024

First Submitted That Met QC Criteria

July 20, 2024

First Posted (Actual)

July 24, 2024

Study Record Updates

Last Update Posted (Actual)

July 24, 2024

Last Update Submitted That Met QC Criteria

July 20, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lunshen（yan）2023.no 10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data will not be shared due to patient privacy concerns, institutional policies, regulatory compliance issues in China, consent limitations in this retrospective study, and the sensitive nature of cancer treatment data. However, the study protocol and statistical analysis plan may be available upon reasonable request to the principal investigator, subject to institutional review board approval and compliance with privacy regulations. Aggregate results and analyses are expected to be published in peer-reviewed journals and presented at scientific conferences. While individual data sharing is not possible, the research team may be open to discussing potential collaborative projects or secondary analyses with interested researchers, subject to necessary approvals and ethical considerations.

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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