Advanced Stage NSCLCHIBIC-NSCLCNCT06518018
Efficacy and Safety of High-Dose Rate Brachytherapy With Immunotherapy and Chemotherapy as Second-Line Treatment for Advanced Non-Small Cell Lung Cancer
An observational study of Advanced Stage NSCLC and Second-line Treatment, run by The First People's Hospital of Neijiang at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Advanced Stage NSCLC, Second-line Treatment, Patients Without Targetable Driver Mutations
- What is being tested?
- HDR brachytherapy (30Gy single fraction) and Immunotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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: 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:
Read more
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.
Read the 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.
- Being tested
- HDR brachytherapy (30Gy single fraction), Immunotherapy
- Keywords
- Second-Line Treatment, High-Dose Rate (HDR) Brachytherapy, Non-Small Cell Lung Cancer (NSCLC), Immune Checkpoint Inhibitors (ICIs), Propensity Score-Matched, Advanced Stage
- Medical subject headings
- Barakat syndrome, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDR brachytherapy (30Gy single fraction)Radiation
Also called ICIs, chemotherapy
Study Group receives a novel triple combination therapy for advanced NSCLC in the second-line setting. The treatment begins with a single fraction of high-dose rate (HDR) brachytherapy, delivering 30 Gy locally to the tumor site. This is followed within 1-3 days by systemic therapy, combining immunotherapy and chemotherapy , both administered intravenously.
ImmunotherapyDrug
Also called chemotherapy
Control Group receives the current standard of care for second-line treatment of advanced NSCLC. This regimen consists of a combination of immunotherapy and chemotherapy , both administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Study Group | HDR Brachytherapy + Immunotherapy + Chemotherapy Group Receives: Radiation: HDR brachytherapy (30Gy single fraction) | |
| Control Group | Immunotherapy + Chemotherapy Group Receives: Drug: Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The proportion of patients achieving either a complete response (CR) or partial response (PR) according to RECIST v1.1 criteria
Measured: Every 8 weeks from baseline up to 24 months or until disease progression, unacceptable toxicity, or withdrawal from the study, whichever occurs first
Secondary outcomes (1)
Progression-Free Survival (PFS)
Time from treatment initiation to disease progression or death from any cause
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Sep 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Advanced Stage NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Neijiang
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ou Jiang, Neijiang No.2 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518018
- Sponsor's protocol ID
- lunshen（yan）2023.no 10
- Acronym
- HIBIC-NSCLC
- Status last verified
- Jul 2024
- First submitted
- 13 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
Chen 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.
PubMed 30093664Tateishi 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.
PubMed 33891980Weichselbaum 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.
PubMed 28094262Twyman-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.
PubMed 25754329Zhang 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.
PubMed 35906199Wu 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.
PubMed 34970277Chen D, Song X, Wang H, Gao Z, Meng W, Chen S, Ma Y, Wang Y, Li K, Yu J, Yue J. Previous Radiotherapy Increases the Efficacy of IL-2 in Malignant Pleural Effusion: Potential Evidence of a Radio-Memory Effect? Front Immunol. 2018 Dec 11;9:2916. doi: 10.3389/fimmu.2018.02916. eCollection 2018.
PubMed 30619280Ko EC, Raben D, Formenti SC. The Integration of Radiotherapy with Immunotherapy for the Treatment of Non-Small Cell Lung Cancer. Clin Cancer Res. 2018 Dec 1;24(23):5792-5806. doi: 10.1158/1078-0432.CCR-17-3620. Epub 2018 Jun 26.
PubMed 29945993Shabason JE, Minn AJ. Radiation and Immune Checkpoint Blockade: From Bench to Clinic. Semin Radiat Oncol. 2017 Jul;27(3):289-298. doi: 10.1016/j.semradonc.2017.03.002. Epub 2017 Mar 16.
PubMed 28577836Taniguchi Y, Shimokawa T, Takiguchi Y, Misumi T, Nakamura Y, Kawashima Y, Furuya N, Shiraishi Y, Harada T, Tanaka H, Miura S, Uchiyama A, Nakahara Y, Tokito T, Naoki K, Bessho A, Goto Y, Seike M, Okamoto H. A Randomized Comparison of Nivolumab versus Nivolumab + Docetaxel for Previously Treated Advanced or Recurrent ICI-Naive Non-Small Cell Lung Cancer: TORG1630. Clin Cancer Res. 2022 Oct 14;28(20):4402-4409. doi: 10.1158/1078-0432.CCR-22-1687.
PubMed 35980349Gandhi SJ, Minn AJ, Vonderheide RH, Wherry EJ, Hahn SM, Maity A. Awakening the immune system with radiation: Optimal dose and fractionation. Cancer Lett. 2015 Nov 28;368(2):185-90. doi: 10.1016/j.canlet.2015.03.024. Epub 2015 Mar 20.
PubMed 25799953Garon EB, Hellmann MD, Rizvi NA, Carcereny E, Leighl NB, Ahn MJ, Eder JP, Balmanoukian AS, Aggarwal C, Horn L, Patnaik A, Gubens M, Ramalingam SS, Felip E, Goldman JW, Scalzo C, Jensen E, Kush DA, Hui R. Five-Year Overall Survival for Patients With Advanced Non-Small-Cell Lung Cancer Treated With Pembrolizumab: Results From the Phase I KEYNOTE-001 Study. J Clin Oncol. 2019 Oct 1;37(28):2518-2527. doi: 10.1200/JCO.19.00934. Epub 2019 Jun 2.
PubMed 31154919Spigel DR, Faivre-Finn C, Gray JE, Vicente D, Planchard D, Paz-Ares L, Vansteenkiste JF, Garassino MC, Hui R, Quantin X, Rimner A, Wu YL, Ozguroglu M, Lee KH, Kato T, de Wit M, Kurata T, Reck M, Cho BC, Senan S, Naidoo J, Mann H, Newton M, Thiyagarajah P, Antonia SJ. Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. J Clin Oncol. 2022 Apr 20;40(12):1301-1311. doi: 10.1200/JCO.21.01308. Epub 2022 Feb 2.
PubMed 35108059Reck 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.
PubMed 33872070Shi JF, Wang L, Wu N, Li JL, Hui ZG, Liu SM, Yang BY, Gao SG, Ren JS, Huang HY, Zhu J, Liu CC, Fan JH, Zhao SJ, Xing PY, Zhang Y, Li N, Lei WD, Wang DB, Huang YC, Liao XZ, Xing XJ, Du LB, Yang L, Liu YQ, Zhang YZ, Zhang K, Qiao YL, He J, Dai M; LuCCRES Group. Clinical characteristics and medical service utilization of lung cancer in China, 2005-2014: Overall design and results from a multicenter retrospective epidemiologic survey. Lung Cancer. 2019 Feb;128:91-100. doi: 10.1016/j.lungcan.2018.11.031. Epub 2018 Nov 24.
PubMed 30642458
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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: A Single-Center, Retrospective, Propensity Score-Matched Study
- ClinicalTrials.gov ID
- NCT06518018
- Acronym / sponsor ID
- HIBIC-NSCLC / lunshen（yan）2023.no 10
- Keywords
- Second-Line Treatment, High-Dose Rate (HDR) Brachytherapy, Non-Small Cell Lung Cancer (NSCLC), Immune Checkpoint Inhibitors (ICIs), Propensity Score-Matched, Advanced Stage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The First People's Hospital of NeijiangUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Radiation: HDR brachytherapy (30Gy single fraction)HDR Brachytherapy + Immunotherapy + Chemotherapy Group |
| Control Group | – | Drug: ImmunotherapyImmunotherapy + Chemotherapy Group |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDR brachytherapy (30Gy single fraction)Also: ICIs, chemotherapyStudy Group receives a novel triple combination therapy for advanced NSCLC in the second-line setting. The treatment begins with a single fraction of high-dose rate (HDR) brachytherapy, delivering 30 Gy locally to the tumor site. This is followed within 1-3 days by systemic therapy, combining immunotherapy and chemotherapy , both administered intravenously. | Radiation | Study Group |
| ImmunotherapyAlso: chemotherapyControl Group receives the current standard of care for second-line treatment of advanced NSCLC. This regimen consists of a combination of immunotherapy and chemotherapy , both administered intravenously | Drug | Control Group |
Primary outcome
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
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Results publication: PubMed 30093664Chen 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.
- Results publication: PubMed 33891980Tateishi 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.
- Results publication: PubMed 28094262Weichselbaum 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.
- Results publication: PubMed 25754329Twyman-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.
- Results publication: PubMed 35906199Zhang 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.
- Results publication: PubMed 34970277Wu 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.
- Results publication: PubMed 30619280Chen D, Song X, Wang H, Gao Z, Meng W, Chen S, Ma Y, Wang Y, Li K, Yu J, Yue J. Previous Radiotherapy Increases the Efficacy of IL-2 in Malignant Pleural Effusion: Potential Evidence of a Radio-Memory Effect? Front Immunol. 2018 Dec 11;9:2916. doi: 10.3389/fimmu.2018.02916. eCollection 2018.
- Results publication: PubMed 29945993Ko EC, Raben D, Formenti SC. The Integration of Radiotherapy with Immunotherapy for the Treatment of Non-Small Cell Lung Cancer. Clin Cancer Res. 2018 Dec 1;24(23):5792-5806. doi: 10.1158/1078-0432.CCR-17-3620. Epub 2018 Jun 26.
- Results publication: PubMed 28577836Shabason JE, Minn AJ. Radiation and Immune Checkpoint Blockade: From Bench to Clinic. Semin Radiat Oncol. 2017 Jul;27(3):289-298. doi: 10.1016/j.semradonc.2017.03.002. Epub 2017 Mar 16.
- Results publication: PubMed 35980349Taniguchi Y, Shimokawa T, Takiguchi Y, Misumi T, Nakamura Y, Kawashima Y, Furuya N, Shiraishi Y, Harada T, Tanaka H, Miura S, Uchiyama A, Nakahara Y, Tokito T, Naoki K, Bessho A, Goto Y, Seike M, Okamoto H. A Randomized Comparison of Nivolumab versus Nivolumab + Docetaxel for Previously Treated Advanced or Recurrent ICI-Naive Non-Small Cell Lung Cancer: TORG1630. Clin Cancer Res. 2022 Oct 14;28(20):4402-4409. doi: 10.1158/1078-0432.CCR-22-1687.
- Results publication: PubMed 25799953Gandhi SJ, Minn AJ, Vonderheide RH, Wherry EJ, Hahn SM, Maity A. Awakening the immune system with radiation: Optimal dose and fractionation. Cancer Lett. 2015 Nov 28;368(2):185-90. doi: 10.1016/j.canlet.2015.03.024. Epub 2015 Mar 20.
- Results publication: PubMed 31154919Garon EB, Hellmann MD, Rizvi NA, Carcereny E, Leighl NB, Ahn MJ, Eder JP, Balmanoukian AS, Aggarwal C, Horn L, Patnaik A, Gubens M, Ramalingam SS, Felip E, Goldman JW, Scalzo C, Jensen E, Kush DA, Hui R. Five-Year Overall Survival for Patients With Advanced Non-Small-Cell Lung Cancer Treated With Pembrolizumab: Results From the Phase I KEYNOTE-001 Study. J Clin Oncol. 2019 Oct 1;37(28):2518-2527. doi: 10.1200/JCO.19.00934. Epub 2019 Jun 2.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Stage NSCLC and Second-line Treatment, run by The First People's Hospital of Neijiang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06518018, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024; AzTrials last refreshed its copy on 26 Oct 2026.