Non-Small Cell Lung CancerPhase 2NCT05348668
Hybrid Dose-fraction Radiotherapy for Metastatic Non-small Cell Lung Cancer
A Phase 2 study testing Hybrid dose-fraction Radiotherapy combined with immune checkpoint inhibitors in people with Non-Small Cell Lung Cancer, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
The combination of immune checkpoint inhibitors (ICI) and local ablative radiotherapy has been demonstrated to be able to increase the survival of patients with metastatic driven-genes negative non-small cell lung cancer. Various dose-fraction of radiotherapy could exert different effects on the immune system. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Hybrid dose-fraction Radiotherapy combined with immune checkpoint inhibitors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2022to 1 May 2025
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old;
- Eastern Cooperative Oncology Group (ECOG) 0-1;
- Non-small cell lung cancer, including squamous-cell carcinoma, adenocarcinoma, large-cell carcinoma, adenosquamous carcinoma;
- Stage IVA and IVB confirmed by radiological examination (AJCC 8th Edition);
- Driven-genes negative including EGFR (Epidermal Growth Factor Receptor), ALK (Anaplastic Lymphoma Kinase), ROS1 (ROS Proto-Oncogene 1), KRAS G12C (Kirsten Rat Sarcoma Viral Oncogene), BRAF V600E (v-raf murine sarcoma viral oncogene homolog B1), MET exon14 (Mesenchymal Epithelial Transition Factor), RET (Rearranged during Transfection Proto-oncogene), NTRK1/2/3 (NeuroTrophin Receptor Kinase);
- First-line treatment of ICI±chemotherapy;
- Partial response (PR) or stable (SD) after first-line treatment;
- Signature of inform consent.
Who cannot join
- younger than 18 years old or older than 75 years old;
- ECOG>1;
- Small-cell lung cancer and other neuroendocrine carcinoma;
- Non stage IV confirmed by radiological examination;
- Driven-genes positive including EGFR, ALK, ROS1, KRAS G12C, BRAF V600E, MET exon14, RET, NTRK1/2/3;
- First-line treatment of other therapy rather than ICI±chemotherapy;
Show all 9Show fewer
- Complete response (CR) or progression (PD) after first-line treatment;
- Contraindications for radiotherapy, chemotherapy and ICI;
- No signature of inform consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hybrid Dose-fraction Radiotherapy for Metastatic Driven-genes Negative Non-small Cell Lung Cancer: A Phase II Multi-institutional Study
The combination of immune checkpoint inhibitors (ICI) and local ablative radiotherapy has been demonstrated to be able to increase the survival of patients with metastatic driven-genes negative non-small cell lung cancer. Various dose-fraction of radiotherapy could exert different effects on the immune system. Ablative-dose could induce immunogenic cell death through the activation of CD8+(Cluster of Differentiation) T cells. Low-dose could modulate immune microenvironment from immunosuppression to inflammatory anti-tumor phenotype. This trial is designed to validation the safety and primary efficacy of the combination of hybrid dose-fraction radiotherapy with ICI for metastatic driven-genes negative non-small cell lung cancer patients.
Read the detailed description
Trial Title: Hybrid dose-fraction Radiotherapy for metastatic driven-genes negative non-small cell lung cancer: A phase II multi-institutional study Trial Objective: To explore the safety and primary efficacy of the combination of hybrid dose-fraction radiotherapy with ICI for metastatic driven-genes negative non-small cell lung cancer patients.
Trial Design: This trial is designed to enroll 74 patients with metastatic driven-genes negative non-small cell lung cancer to receive the combination of hybrid dose-fraction radiotherapy with ICI.
Staging Examination before Radiotherapy: a. ECOG scoring. b. Cranial contrast MRI and PET-CT (Positron Emissions Tomography), or cranial contrast MRI (preferred), chest contrast CT, abdominal ultrasonography and bone scan. c. Bronchoscopy for centrally located lung cancer.
Inductive therapy ICI±chemotherapy for 4-6 cycles. Pembrolizumab and Tislelizumab are preferred. Chemotherapy regimens could be referred to NCCN (National Comprehensive Cancer Network) guidelines.
Restaging examination after inductive therapy is mandatory: a. ECOG scoring. b. Cranial contrast MRI, chest contrast CT, abdominal ultrasonography.
Patients with disease PR or SD (RECIST v1.1) evaluated by restaging after inductive therapy could be included into this trial. Patients would receive hybrid dose-fraction radiotherapy and ICI maintenance.
Radiotherapy CT Simulation: CT with intravenous contrast is recommended for simulation. Scan thickness should be less than 5 mm from lower margin of mandibular to lower margin of L2. For pulmonary lesions, 4D-CT (Four-Dimensional CT) localization is recommended.
Delineation of Targets:
For patients with oligometastasis, including synchronous oligometastatic disease \& metachronous oligorecurrence, all lesions should be prescribed with an ablative dose. The dose-fraction modalities are as following:
Thoracic lesions: 50Gy/5f (50 Gray/5 fractions), 60Gy/8f, 60Gy/15f, 48Gy/12f. Intracranial lesions: 30Gy/10f (Whole Brain Irradiation), 30Gy/3f, 30Gy/5f, 45Gy/15f.
Hepatic lesions: 50Gy/5f, 40Gy/5f, 32Gy/4f. Adrenal lesions: 50Gy/5f, 40Gy/5f, 32Gy/4f. Osseous lesions: 27Gy/3f, 40Gy/5f, 30Gy/5f, 39Gy/13f. Other lesions: Refer to the above dose-fraction. For patients with systemic metastasis, high-dose should be prescribed to 1-3 lesions (longest diameter>1cm). All of the remaining lesions should be given low-dose. High-dose includes 24-40Gy/3-5f. Low-dose includes 6-15Gy/4-10f.
The Planning Target Volume (PTV) was defined as an 8-mm margin of the GTV (Gross Tumor Volumn) for tumor motion and set-up variations.
The delivery of ablative dose and high-dose should utilize the technology of SABR (Stereotactic Ablative Body Radiotherapy).
Dosimetric Limitation of Organ at Risk: 95% prescription dose should cover 100% PTV and 95% PTV should receive 100% prescription dose.
The dose constraints of organs at risk could refer to TG 101 (Task Group 101) report.
Treatment Implementation: Radiotherapy is implemented every day. Cone-beam CT should be utilized every day to minimize set-up error.
Follow-up: Patients should be follow-up every three months right after the completion of radiotherapy to disease progression.
Primary Endpoint: Progress-free Survival (PFS).
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Hybrid dose-fraction Radiotherapy combined with immune checkpoint inhibitors
- Keywords
- metastatic driven-genes negative non-small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid dose-fraction Radiotherapy combined with immune checkpoint inhibitorsDrug
Also called no other interventions
Hybrid dose-fraction Radiotherapy combined with immune checkpoint inhibitors
| Study group | Role | What they receive |
|---|---|---|
| Hybrid dose-fraction Radiotherapy Arm | Experimental | Patients in this arm would receive hybrid dose-fraction radiotherapy combined with immune checkpoint inhibitors. Receives: Drug: Hybrid dose-fraction Radiotherapy combined with immune checkpoint inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Progression-free Survival evaluated by RECIST (v1.1)
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start9 May 2022
- Primary completion1 Mar 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 74 patients with metastatic driven-genes negative non-small cell lung cancer to receive the combination of hybrid dose-fraction radiotherapy with ICI
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dong Qian, Anhui Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348668
- Sponsor's protocol ID
- 2021-ky301
- Status last verified
- Jul 2026
- First submitted
- 21 Apr 2022
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Dose-fraction Radiotherapy for Metastatic Driven-genes Negative Non-small Cell Lung Cancer: A Phase II Multi-institutional Study
- ClinicalTrials.gov ID
- NCT05348668
- Acronym / sponsor ID
- 2021-ky301
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- metastatic driven-genes negative non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 9 May 2022 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 27 Apr 2022 (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.
The combination of immune checkpoint inhibitors (ICI) and local ablative radiotherapy has been demonstrated to be able to increase the survival of patients with metastatic driven-genes negative non-small cell lung cancer. Various dose-fraction of radiotherapy could exert different effects on the immune system. Ablative-dose could induce immunogenic cell death through the activation of CD8+(Cluster of Differentiation) T cells. Low-dose could modulate immune microenvironment from immunosuppression to inflammatory anti-tumor phenotype. This trial is designed to validation the safety and primary efficacy of the combination of hybrid dose-fraction radiotherapy with ICI for metastatic driven-genes negative non-small cell lung cancer patients.
Detailed description
Trial Title: Hybrid dose-fraction Radiotherapy for metastatic driven-genes negative non-small cell lung cancer: A phase II multi-institutional study Trial Objective: To explore the safety and primary efficacy of the combination of hybrid dose-fraction radiotherapy with ICI for metastatic driven-genes negative non-small cell lung cancer patients.
Trial Design: This trial is designed to enroll 74 patients with metastatic driven-genes negative non-small cell lung cancer to receive the combination of hybrid dose-fraction radiotherapy with ICI.
Staging Examination before Radiotherapy: a. ECOG scoring. b. Cranial contrast MRI and PET-CT (Positron Emissions Tomography), or cranial contrast MRI (preferred), chest contrast CT, abdominal ultrasonography and bone scan. c. Bronchoscopy for centrally located lung cancer.
Inductive therapy ICI±chemotherapy for 4-6 cycles. Pembrolizumab and Tislelizumab are preferred. Chemotherapy regimens could be referred to NCCN (National Comprehensive Cancer Network) guidelines.
Restaging examination after inductive therapy is mandatory: a. ECOG scoring. b. Cranial contrast MRI, chest contrast CT, abdominal ultrasonography.
Patients with disease PR or SD (RECIST v1.1) evaluated by restaging after inductive therapy could be included into this trial. Patients would receive hybrid dose-fraction radiotherapy and ICI maintenance.
Radiotherapy CT Simulation: CT with intravenous contrast is recommended for simulation. Scan thickness should be less than 5 mm from lower margin of mandibular to lower margin of L2. For pulmonary lesions, 4D-CT (Four-Dimensional CT) localization is recommended.
Delineation of Targets:
For patients with oligometastasis, including synchronous oligometastatic disease \& metachronous oligorecurrence, all lesions should be prescribed with an ablative dose. The dose-fraction modalities are as following:
Thoracic lesions: 50Gy/5f (50 Gray/5 fractions), 60Gy/8f, 60Gy/15f, 48Gy/12f. Intracranial lesions: 30Gy/10f (Whole Brain Irradiation), 30Gy/3f, 30Gy/5f, 45Gy/15f.
Hepatic lesions: 50Gy/5f, 40Gy/5f, 32Gy/4f. Adrenal lesions: 50Gy/5f, 40Gy/5f, 32Gy/4f. Osseous lesions: 27Gy/3f, 40Gy/5f, 30Gy/5f, 39Gy/13f. Other lesions: Refer to the above dose-fraction. For patients with systemic metastasis, high-dose should be prescribed to 1-3 lesions (longest diameter>1cm). All of the remaining lesions should be given low-dose. High-dose includes 24-40Gy/3-5f. Low-dose includes 6-15Gy/4-10f.
The Planning Target Volume (PTV) was defined as an 8-mm margin of the GTV (Gross Tumor Volumn) for tumor motion and set-up variations.
The delivery of ablative dose and high-dose should utilize the technology of SABR (Stereotactic Ablative Body Radiotherapy).
Dosimetric Limitation of Organ at Risk: 95% prescription dose should cover 100% PTV and 95% PTV should receive 100% prescription dose.
The dose constraints of organs at risk could refer to TG 101 (Task Group 101) report.
Treatment Implementation: Radiotherapy is implemented every day. Cone-beam CT should be utilized every day to minimize set-up error.
Follow-up: Patients should be follow-up every three months right after the completion of radiotherapy to disease progression.
Primary Endpoint: Progress-free Survival (PFS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 74 patients with metastatic driven-genes negative non-small cell lung cancer to receive the combination of hybrid dose-fraction radiotherapy with ICI
| Arm | Type | Receives |
|---|---|---|
| Hybrid dose-fraction Radiotherapy Arm | Experimental | Drug: Hybrid dose-fraction Radiotherapy combined with immune checkpoint inhibitorsPatients in this arm would receive hybrid dose-fraction radiotherapy combined with immune checkpoint inhibitors. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-75 years old;
- Eastern Cooperative Oncology Group (ECOG) 0-1;
- Non-small cell lung cancer, including squamous-cell carcinoma, adenocarcinoma, large-cell carcinoma, adenosquamous carcinoma;
- Stage IVA and IVB confirmed by radiological examination (AJCC 8th Edition);
- Driven-genes negative including EGFR (Epidermal Growth Factor Receptor), ALK (Anaplastic Lymphoma Kinase), ROS1 (ROS Proto-Oncogene 1), KRAS G12C (Kirsten Rat Sarcoma Viral Oncogene), BRAF V600E (v-raf murine sarcoma viral oncogene homolog B1), MET exon14 (Mesenchymal Epithelial Transition Factor), RET (Rearranged during Transfection Proto-oncogene), NTRK1/2/3 (NeuroTrophin Receptor Kinase);
Key exclusion criteria (9 listed)
- younger than 18 years old or older than 75 years old;
- ECOG>1;
- Small-cell lung cancer and other neuroendocrine carcinoma;
- Non stage IV confirmed by radiological examination;
- Driven-genes positive including EGFR, ALK, ROS1, KRAS G12C, BRAF V600E, MET exon14, RET, NTRK1/2/3;
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 |
|---|---|---|
| Hybrid dose-fraction Radiotherapy combined with immune checkpoint inhibitorsAlso: no other interventionsHybrid dose-fraction Radiotherapy combined with immune checkpoint inhibitors | Drug | Hybrid dose-fraction Radiotherapy Arm |
Primary outcome
Progression-free Survival
Time frame: 1-year
Progression-free Survival evaluated by RECIST (v1.1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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?
A Phase 2 study testing Hybrid dose-fraction Radiotherapy combined with immune checkpoint inhibitors in people with Non-Small Cell Lung Cancer, run by Anhui Provincial Hospital 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 8 inclusion and 9 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: finished, as of the sponsor's last update on 14 Aug 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression-free Survival (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2026.