Clinical trial · Observational
Efficacy and Safety of High-Dose Rate Brachytherapy With Immunotherapy and Chemotherapy as Second-Line Treatment for Advanced Non-Small Cell Lung Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Stage NSCLC | — | UNRESOLVED | — |
| Patients Without Targetable Driver Mutations | — | UNRESOLVED | — |
| Second-line Treatment | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HDR brachytherapy (30Gy single fraction) | Radiation | — | UNRESOLVED |
| Immunotherapy | Drug | Immunotherapy | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Study Group
- description
- HDR Brachytherapy + Immunotherapy + Chemotherapy Group
- interventionNames
- Radiation: HDR brachytherapy (30Gy single fraction)
- label
- Control Group
- description
- Immunotherapy + Chemotherapy Group
- interventionNames
- Drug: Immunotherapy
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Every 8 weeks from baseline up to 24 months or until disease progression, unacceptable toxicity, or withdrawal from the study, whichever occurs first
- description
- The proportion of patients achieving either a complete response (CR) or partial response (PR) according to RECIST v1.1 criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (16)
- RESULTChen HY, Xu L, Li LF, Liu XX, Gao JX, Bai YR. Inhibiting the CD8+ T cell infiltration in the tumor microenvironment after radiotherapy is an important mechanism of radioresistance. Sci Rep. 2018 Aug 9;8(1):11934. doi: 10.1038/s41598-018-30417-6. PMID 30093664
- RESULTTateishi Y, Takeda A, Horita N, Tsurugai Y, Eriguchi T, Kibe Y, Sanuki N, Kaneko T. Stereotactic Body Radiation Therapy With a High Maximum Dose Improves Local Control, Cancer-Specific Death, and Overall Survival in Peripheral Early-Stage Non-Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2021 Sep 1;111(1):143-151. doi: 10.1016/j.ijrobp.2021.04.014. Epub 2021 Apr 21. PMID 33891980
- RESULTWeichselbaum RR, Liang H, Deng L, Fu YX. Radiotherapy and immunotherapy: a beneficial liaison? Nat Rev Clin Oncol. 2017 Jun;14(6):365-379. doi: 10.1038/nrclinonc.2016.211. Epub 2017 Jan 17. PMID 28094262
- RESULTTwyman-Saint Victor C, Rech AJ, Maity A, Rengan R, Pauken KE, Stelekati E, Benci JL, Xu B, Dada H, Odorizzi PM, Herati RS, Mansfield KD, Patsch D, Amaravadi RK, Schuchter LM, Ishwaran H, Mick R, Pryma DA, Xu X, Feldman MD, Gangadhar TC, Hahn SM, Wherry EJ, Vonderheide RH, Minn AJ. Radiation and dual checkpoint blockade activate non-redundant immune mechanisms in cancer. Nature. 2015 Apr 16;520(7547):373-7. doi: 10.1038/nature14292. Epub 2015 Mar 9. PMID 25754329
- RESULTZhang Z, Liu X, Chen D, Yu J. Radiotherapy combined with immunotherapy: the dawn of cancer treatment. Signal Transduct Target Ther. 2022 Jul 29;7(1):258. doi: 10.1038/s41392-022-01102-y. PMID 35906199
- RESULTWu M, Liu J, Wu S, Liu J, Wu H, Yu J, Meng X. Systemic Immune Activation and Responses of Irradiation to Different Metastatic Sites Combined With Immunotherapy in Advanced Non-Small Cell Lung Cancer. Front Immunol. 2021 Dec 14;12:803247. doi: 10.3389/fimmu.2021.803247. eCollection 2021. PMID 34970277