Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05486650
Other study ID # 2021-yandi147-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2022
Est. completion date July 31, 2026

Study information

Verified date February 2024
Source Xinqiao Hospital of Chongqing
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

After the treatment of advanced non-small cell lung cancer with immune checkpoint inhibitor PD-1/PD-L1 monoclonal antibody, if the treatment response of complete response (CR) or partial response (PR) can be achieved in the early stage, the patients are expected to obtain a better long-term survival rate. Radiotherapy can synergistically improve the effect of immunotherapy. Therefore, we propose a hypothesis: in patients with advanced lung cancer, if only stable disease (SD) is achieved after PD-1 antibody immunotherapy in the early stage, by increasing the stereotactic radiotherapy (SBRT) for primary or metastatic lesions, in order to improve the mechanism of tumor antigen release, promote the activation and activation of effector T cells, and increase the sensitivity of immunotherapy, so as to achieve the goal of early improvement of objective remission rate (ORR). It is expected to improve the long-term survival rate of patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date July 31, 2026
Est. primary completion date July 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Informed consent has been signed, and according to the judgment of the investigator, the patient can comply with the study protocol; 2. Patients with stage IIIB, IIIC and stage IV NSCLC (according to the definition of the 8th edition of the American Joint Commission on cancer), who have not been treated and cannot receive radical surgery or radiotherapy confirmed by histopathology, received 3-4 cycles of PD1 antibody ± chemotherapy in the early stage, and the efficacy was evaluated as SD; 3. Previously, no EGFR sensitive mutation and ALK, ROS1 gene fusion mutation were detected based on tissue examination; 4. There are measurable lesions evaluated by researchers according to RECIST version 1.1; 5. The physical state score (ECOG PS) of the eastern cancer cooperation group was 0-1; 6. Good cardiopulmonary function Exclusion Criteria: 1. The patient's compliance is poor and violates the test regulations; 2. Patients with positive driver gene are known to carry EGFR mutation or ALK, ROS1 gene translocation; 3. There are dysfunction of important organs of liver and kidney, such as myocardial infarction, angina pectoris, liver transaminase significantly increased; 4. Serious adverse drug reactions occurred during induction; 5. Have suffered from any disease requiring systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days before enrollment; 6. Severe infection occurred within 4 weeks before enrollment, including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia; 7. Severe chronic or active infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibiotic treatment within 14 days before enrollment; 8. Have a history of interstitial lung disease, non infectious pneumonia or poorly controlled diseases, including pulmonary fibrosis, acute lung disease, etc; 9. Untreated patients with chronic hepatitis B, HBV carriers with hepatitis B virus (HBV) DNA = 500 iu/ml, or patients with active hepatitis C virus (HCV) should be excluded; 10. Known history of HIV infection; 11. Received any other trial drug treatment or participated in other clinical trials within 28 days.

Study Design


Intervention

Drug:
PD-1 inhibitor
After receiving PD-1 inhibitor treatment in the first three cycles, patients with locally advanced or advanced NSCLC whose curative effect is evaluated as stable disease receive SBRT combined with PD-1 inhibitor treatment

Locations

Country Name City State
China the second affiliated hospital of Army medical university Chongqing Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary objective response rate (ORR) The proportion of patients whose tumors shrink to a certain amount and remain for a certain period of time, including cases of complete response and partial response. 2 year
See also
  Status Clinical Trial Phase
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Recruiting NCT05707286 - Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
Recruiting NCT04258137 - Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study N/A
Completed NCT01945021 - Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC Phase 2
Completed NCT04487457 - Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
Terminated NCT04022876 - A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection) Phase 1
Recruiting NCT05898763 - TEIPP Immunotherapy in Patients With NSCLC Phase 1/Phase 2
Recruiting NCT05532696 - Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients Phase 1/Phase 2
Completed NCT04311034 - A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer Phase 1/Phase 2
Active, not recruiting NCT03177291 - Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC Phase 1
Terminated NCT03257722 - Pembrolizumab + Idelalisib for Lung Cancer Study Phase 1/Phase 2
Completed NCT00349089 - Trial on Refinement of Early Stage Lung Cancer Adjuvant Therapy Phase 2
Completed NCT05116891 - A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT04571632 - Clinical Trial of SBRT and Systemic Pembrolizumab With or Without Avelumab/Ipilimumab+ Dendritic Cells in Solid Tumors Phase 2
Terminated NCT03599518 - DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer Phase 1
Not yet recruiting NCT06020989 - Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy Phase 2
Withdrawn NCT03982134 - PDR001 + Panobinostat for Melanoma and NSCLC Phase 1
Withdrawn NCT03574649 - QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer Phase 2
Withdrawn NCT02844140 - DE-CT in Lung Cancer Proton Therapy N/A
Completed NCT03780010 - Study of TRC105 + Paclitaxel/Carboplatin and Bevacizumab in Patients With NSCLC Phase 1