NSCLC Stage IVPhase 2NCT06313541
Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy
A Phase 2 study testing SBRT or LDRT and PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy in people with NSCLC Stage IV, run by Fudan University at 1 site in China.
Trial summary
This study is a multicenter, randomized controlled clinical trial to explore the preliminary efficacy and safety of treatment response adapted hybrid radiotherapy (LDRT and SBRT) in the first-line treatment of immunotherapy combined with chemotherapy for advanced driver-gene negative NSCLC, and to provide new ideas… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC Stage IV
- What is being tested?
- SBRT or LDRT and PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2024to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG functional status score was 0-1.
- Histologically confirmed stage IV primary NSCLC;
- Genetic testing showed that the common driver genes including EGFR, ALK and ROS-1 were negative;
- Patients with brain metastases were eligible if they were neurologically asymptomatic and had stable disease without receiving systemic glucocorticoids;
- According to the investigator's judgment, the patient does not need to receive palliative radiotherapy for any site at present;
- Male/female of childbearing age agreed to use contraception (surgical ligation or oral contraceptive/intrauterine device plus condom) during the trial;
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- Life expectancy ≥3 months;
- One week before enrollment, the organ function level met the following criteria:
- ① Bone marrow function: hemoglobin ≥80g/L, white blood cell count ≥4.010^9/L or neutrophil count ≥1.510^9/L, platelet count ≥10010^9/L;
- ② Liver: serum total bilirubin level ≤1.5 times upper limit of normal, direct bilirubin level must be ≤1.5 times upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times upper limit of normal;
- ③ Kidney: serum creatinine < 1.5 times upper limit of normal or creatinine clearance ≥50ml/min, urea nitrogen ≤200mg/L; Serum albumin ≥30g/L;
- Patients must be able to understand and voluntarily sign the informed consent form.
Who cannot join
- The patient had severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granulomatosis), etc.
- Symptomatic interstitial lung disease or active infectious/non-infectious pneumonia;
- Patients with risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other known risk factors for intestinal perforation;
- History of other malignant tumors;
- Patients with active infection, heart failure, myocardial infarction, unstable angina or unstable arrhythmia within the past 6 months;
- Medical examination or clinical findings, or other uncontrollable conditions that the investigator considers may interfere with the results or increase the patient's risk of treatment complications;
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- Patients who were considered by the investigator to have lesions requiring palliative and subtractive radiotherapy;
- Mixed with small cell lung cancer components;
- Lactating or pregnant women;
- Congenital or acquired immunodeficiency diseases including human immunodeficiency virus (HIV), organ transplantation or allogeneic stem cell transplantation;
- Known HBV, HCV, active pulmonary tuberculosis infection;
- Patients had received a cancer vaccine or received another vaccine within 4 weeks before starting treatment (note: injectable seasonal influenza vaccine is usually inactivated, so vaccination is allowed, while intranasal vaccine is usually live attenuated, so it is not allowed);
- Patients with concurrent use of other immune agents, chemotherapy drugs, drugs in other clinical studies, and long-term use of cortisol were excluded.
- Patients with mental disorders, substance abuse, or social problems that affect adherence were excluded from the study after physician review;
- Patients who are allergic to or contraindicated to PD-1 monoclonal antibody or chemotherapy drugs.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Zhengfei Zhu, MD, +86-18017312901, fuscczzf@163.com
Jianjiao Ni, MD, 13761974092, nijianjiao8@sina.com
About this study
Official title: A Multicenter, Randomized Controlled Clinical Trial of Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy
This study is a multicenter, randomized controlled clinical trial to explore the preliminary efficacy and safety of treatment response adapted hybrid radiotherapy (LDRT and SBRT) in the first-line treatment of immunotherapy combined with chemotherapy for advanced driver-gene negative NSCLC, and to provide new ideas for the comprehensive treatment of advanced NSCLC
- Conditions
- NSCLC Stage IV
- Being tested
- SBRT or LDRT, PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy
- 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.
SBRT or LDRTRadiation
Radiotherapy: (1) Low dose radiotherapy (LDRT) : a dose of 2 Gy/1 Fx was given to all visible lesions in the whole body within 1 week before the first course of PD-1/PD-L1 inhibitor combined with chemotherapy (different parts of the lesion could be irradiated separately, but it was required to be completed within 1 week); (2) SBRT: patients received first-line immunotherapy combined with chemotherapy, and their response was evaluated every 6 weeks. Individualized SBRT was planned based on the treatment responses.
PD-1/PD-L1 inhibitor combined with platinum-based chemotherapyDrug
The control group received standard PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy as first-line treatment, and the experimental group received extra treatment response adapted hybrid radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| PD-1/PD-L1 inhibitor combined with chemotherapy | Active comparator | Not described Receives: Drug: PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy |
| Treatment response adapted hybrid radiotherapy plus PD-1/PD-L1 inhibitor and chemotherapy | Experimental | Not described Receives: Radiation: SBRT or LDRT; Drug: PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
The time from enrollment to disease progression or death from any cause. Patients who were still alive at the time of analysis will have the date of their last contact as the cutoff date.
Measured: Two years
Secondary outcomes (4)
Overall Survival
The time from enrollment to death from any cause. Patients who were still alive at the time of analysis will have the date of their last contact as the cutoff date.
Measured: Two years
Objective response rate
According to RECISIT1.1 criteria, the proportion of patients achieving CR and PR as their best response before initial disease progression was evaluated.
Measured: Two years
Progression free survival 2
The time between enrollment and the observation of second disease progression or the occurrence of death from any cause. Patients who were still alive at the time of analysis will have the date of their last contact as the cutoff date.
Measured: Two years
Treatment-related adverse event
Investigator-assessed treatment-related adverse events were recorded and assessed according to CTCAE5.0
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start10 Apr 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IVStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhengfei Zhu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313541
- Sponsor's protocol ID
- 2024-Lung-LDRT/SBRT
- Status last verified
- Jun 2024
- First submitted
- 10 Mar 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled Clinical Trial of Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy
- ClinicalTrials.gov ID
- NCT06313541
- Acronym / sponsor ID
- 2024-Lung-LDRT/SBRT
- Conditions
- NSCLC Stage IV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Mar 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 study is a multicenter, randomized controlled clinical trial to explore the preliminary efficacy and safety of treatment response adapted hybrid radiotherapy (LDRT and SBRT) in the first-line treatment of immunotherapy combined with chemotherapy for advanced driver-gene negative NSCLC, and to provide new ideas for the comprehensive treatment of advanced NSCLC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD-1/PD-L1 inhibitor combined with chemotherapy | Active comparator | Drug: PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy |
| Treatment response adapted hybrid radiotherapy plus PD-1/PD-L1 inhibitor and chemotherapy | Experimental | Radiation: SBRT or LDRT, Drug: PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- ECOG functional status score was 0-1.
- Histologically confirmed stage IV primary NSCLC;
- Genetic testing showed that the common driver genes including EGFR, ALK and ROS-1 were negative;
- Patients with brain metastases were eligible if they were neurologically asymptomatic and had stable disease without receiving systemic glucocorticoids;
- According to the investigator's judgment, the patient does not need to receive palliative radiotherapy for any site at present;
Key exclusion criteria (15 listed)
- The patient had severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granulomatosis), etc.
- Symptomatic interstitial lung disease or active infectious/non-infectious pneumonia;
- Patients with risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other known risk factors for intestinal perforation;
- History of other malignant tumors;
- Patients with active infection, heart failure, myocardial infarction, unstable angina or unstable arrhythmia within the past 6 months;
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 |
|---|---|---|
| SBRT or LDRTRadiotherapy: (1) Low dose radiotherapy (LDRT) : a dose of 2 Gy/1 Fx was given to all visible lesions in the whole body within 1 week before the first course of PD-1/PD-L1 inhibitor combined with chemotherapy (different parts of the lesion could be irradiated separately, but it was required to be completed within 1 week); (2) SBRT: patients received first-line immunotherapy combined with chemotherapy, and their response was evaluated every 6 weeks. Individualized SBRT was planned based on the treatment responses. | Radiation | Treatment response adapted hybrid radiotherapy plus PD-1/PD-L1 inhibitor and chemotherapy |
| PD-1/PD-L1 inhibitor combined with platinum-based chemotherapyThe control group received standard PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy as first-line treatment, and the experimental group received extra treatment response adapted hybrid radiotherapy. | Drug | PD-1/PD-L1 inhibitor combined with chemotherapy, Treatment response adapted hybrid radiotherapy plus PD-1/PD-L1 inhibitor and chemotherapy |
Primary outcome
Progression Free Survival
Time frame: Two years
The time from enrollment to disease progression or death from any cause. Patients who were still alive at the time of analysis will have the date of their last contact as the cutoff date.
4 secondary outcomes
Overall Survival
Time frame: Two years
Objective response rate
Time frame: Two years
Progression free survival 2
Time frame: Two years
Treatment-related adverse event
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
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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.
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 SBRT or LDRT and PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy in people with NSCLC Stage IV, run by Fudan University 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 12 inclusion and 15 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 5 Jun 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhengfei Zhu (+86-18017312901, fuscczzf@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: Two years). 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 5 Jun 2024.