Non-small Cell Lung Cancer MetastaticPhase 2IMCORT-2NCT05472467
Camrelizumab Combination With SBRT and Concurrent Chemotherapy Treated Stage IV Oligometastatic Non-small Cell Lung Cancer
A Phase 2 study testing Camrelizumab, stereotactic body radiation therapy and Chemotherapy in people with Non-small Cell Lung Cancer Metastatic, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial summary
This study evaluated the effectiveness and safety of Camrelizumab combination with SBRT and concurrent chemotherapy treated stage IV oligometastatic non-small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-small Cell Lung Cancer Metastatic
- What is being tested?
- Camrelizumab, stereotactic body radiation therapy and Chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 21 Dec 2021to 20 Dec 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients voluntarily enrolled in this study and signed the informed consent form (ICF).
- Good compliance and cooperation with follow-up.
- age: 18 to 75 years, both sexes.
- ECOG PS: 0 to 1 score.
- patients with non-small cell lung cancer clearly diagnosed by pathology, with measurable tumor lesions (oligometastases ≥10 mm in length, meeting mRECIST1.1 criteria).
- subjects with clinical stage IV according to the 8th edition of the Clinical Oncology TNM staging Stage IV (≤5 oligometastases, ≤3 metastatic organs, and measurable metastases) non-small cell lung cancer patients according to the 8th edition of TNM staging.
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- 5. patients with stage IV clinical stage (number of oligometastases ≤ 5, metastatic organs ≤ 3, and measurable metastases) non-small cell lung cancer 6. vital organ function meets the following requirements (no blood components and cell growth are allowed 2 weeks prior to the start of study treatment) (No blood components or cell growth factors are allowed 2 weeks prior to the start of study treatment).
- Routine blood tests must meet the following requirements.
- absolute neutrophil count (ANC) ≥ 1.5 x 109
- L.
- Hemoglobin (HB) ≥ 9 g/dL.
- Platelets (PLT) ≥ 100×109 /L.
- serum albumin (ALB) ≥ 2.8g/dL. (2) Biochemical examination shall comply with.
- total bilirubin (TBIL) ≤ 1.5 ULN. b) ALT, AST ≤ 2.5 UILN (if liver function abnormalities due to liver metastases, then ≤ 5 ULN) b) ALT, AST ≤ 2.5 UILN (≤ 5 ULN if liver function abnormalities are due to liver metastasis).
- serum creatinine sCr ≤ 1.5 ULN, endogenous creatinine clearance c) serum creatinine sCr ≤ 1.5 ULN and endogenous creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula).
- 7. expected survival ≥ 3 months. 8. the patient is judged by the investigator to be amenable to treatment with kallikreinumab 9. the patient has no autoimmune disease. 10. the patient has not received prior treatment with PD-1/PD-L1 inhibitors. 11. tissue or plasma genetic testing for common lung cancer driver genes such as EGFR, ALK, ROS, RET, HER2, MET, BRAF negative, or no accessible targeted drugs or who are intolerant to targeted drug therapy.
- 12. Female subjects of childbearing potential should receive their first study drug administration within 12. Female subjects of childbearing potential should have a urine or serum pregnancy test within 72 hours prior to the first study drug administration and demonstrate 12. Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to the first dose of study drug and be willing to use validated methods during the trial until 3 months after the last administration of cariolizumab. Male subjects whose partners are women of childbearing potential should use an effective method of contraception for the duration of the trial and for 3 months after the last administration of cariolizumab. Male subjects whose partners are women of childbearing potential should use an effective method of contraception during the trial and for 3 months after the last administration of carreliximab
Who cannot join
- patients who do not meet the inclusion criteria for type of pathology and site of primary focus.
- with diffuse brain metastases and meningeal metastases
- have any active autoimmune disease or a history of autoimmune disease such as inter stromal pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after normal hormone replacement therapy).
- may be included after normalization of hormone replacement therapy).
- patients with asthma requiring medical intervention with bronchodilators
- patients with uncontrolled cardiac clinical symptoms or disease, such as. (1) NYHA class II or higher heart failure. (2) Unstable angina pectoris. (3) Myocardial infarction within 1 year. (4) Clinically significant supraventricular or ventricular arrhythmias requiring clinical (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.
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- active infection or unexplained fever of >38.5°C (0.5 mg/kg) during screening or before the first dose Fever >38.5°C (in the judgment of the investigator, subjects with fever due to tumor fever can be enrolled).
- a known history or evidence of interstitial lung disease or active non-infectious pneumonia
- have a congenital or acquired immune deficiency (e.g., HIV-infected), active Hepatitis B (HBV-DNA ≥ 104 copies/mL) or Hepatitis C (Hepatitis C antibody positive and HCV-RNA above the lower limit of detection for the assay).
- prior treatment with other PD-1 monoclonal antibodies or other immunotherapy against PD-1/PDL1
- known hypersensitivity to macromolecular protein agents, or to any of the components of kareolizumab sensitization.
- Requirement for corticosteroids (>10 mg/day, prednisone) within 14 days prior to first administration of study drug.
- 10 mg/day, prednisone efficacy dose) or other immunosuppressive agents for systemic therapy within 14 days prior to the first Subjects on systemic therapy with corticosteroids (> 10 mg/day, prednisone efficacy dose) or other immunosuppressive agents within 14 days prior to first study drug administration. In the absence of active autoimmune disease In the absence of active autoimmune disease, inhaled or topical steroids and adrenaline at doses >10 mg/day, prednisone efficacy dose are allowed.
- Adrenocorticosteroid replacement at efficacious doses of prednisone. 12. have received an antitumor monoclonal antibody (mAb) within 4 weeks prior to the first administration of study drug (mAb) within 4 weeks prior to the first administration of study drug, or adverse events from previously received drugs have not Recovery (i.e., ≤ grade 1 or at baseline level). Note: Occurrence of ≤ grade 2 neuropathy or ≤ grade 2 alopecia.
- Note: Subjects with ≤ grade 2 neuropathy or ≤ grade 2 alopecia are excluded if the subject has undergone major surgery.
- If the subject has undergone major surgery, the toxic effects and/or complications of the surgical intervention must be adequately addressed prior to initiation of treatment.
- Subjects who have undergone major surgery must have recovered sufficiently from the toxic effects and/or complications of their surgical intervention prior to initiation of treatment.
- 13. the subject is participating in another clinical study 14. the subject has received a live vaccine within 4 weeks prior to the first administration of the study drug and is allowed to receive injectable 14. Receipt of inactivated viral vaccine for seasonal influenza, by injection, but not receive live attenuated influenza vaccine administered via intranasal route. 15. subjects who, in the judgment of the investigator, have other factors that may force them to terminate the other factors that, in the judgment of the investigator, may force him or her to terminate the study, such as other serious illnesses (including mental illness) requiring comorbid treatment, severely abnormal laboratory test values, family or social factors that circumstances that may affect the safety of the subject or the collection of trial data.
- 16. other circumstances that, in the judgment of the investigator, make inclusion in this study inappropriate
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sichuan Cancer Hospital & Institute
Chengdu, Sichuan, 610041
TAO LI, MD, PhD, 86-18908178818, litaoxmf@163.com
TAO LI, MD, PhD
About this study
Official title: Camrelizumab Combination With SBRT and Concurrent Chemotherapy Treated Stage IV Oligometastatic Non-small Cell Lung Cancer ，a Single-arm, Single-center, Exploratory Clinical Study（IMCORT-2）
This study evaluated the effectiveness and safety of Camrelizumab combination with SBRT and concurrent chemotherapy treated stage IV oligometastatic non-small cell lung cancer
Read the detailed description
This study evaluated the effectiveness and safety of Camrelizumab combination with SBRT and concurrent chemotherapy treated stage IV oligometastatic non-small cell lung cancer.
The primary endpoint is ORR. Secondary points contains：PFS、OS、DCR、Qol.
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Being tested
- Camrelizumab, stereotactic body radiation therapy, Chemotherapy
- Keywords
- NSCLC,Camrelizumab,SBRT,oligometastatic
- 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.
CamrelizumabDrug
200mg IV Q3W. Every three weeks is a cycle
stereotactic body radiation therapyRadiation
Also called SBRT
stereotactic body radiation therapy for Oligometastases 35Gy/5f(7.0Gy/f,5f per week)
ChemotherapyDrug
Squamous carcinoma: docetaxel 60 mg/m2, d1 + cisplatin 25 mg/m2, d1-3 or carboplatin AUC=4-6 d1, 21 days for one cycle, up to 4 cycles.
Non-squamous carcinoma: pemetrexed 500 mg/m2, d1 + cisplatin 25 mg/m2, d1-3 or carboplatin AUC=4-6, d1,21 days for one cycle, up to 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Immunotherapy combined with Stereotactic Body Radiation Therapy | Experimental | 1. Camrelizumab： 200mg IV Q3W
2. Chemotherapy：Squamous carcinoma: docetaxel 60 mg/m2, d1 + cisplatin 25 mg/m2, d1-3 or carboplatin AUC=4-6 d1, 21 days for one cycle, up to 4 cycles.
Non-squamous carcinoma: pemetrexed 500 mg/m2, d1 + cisplatin 25 mg/m2, d1-3 or carboplatin AUC=4-6, d1,21 days for one cycle, up to 4 cycles.
3. Stereotactic Body Radiation Therapy(SBRT) for Oligometastatic the total dose 35Gy/5f(7.0Gy/f,5f per week)。 Receives: Drug: Camrelizumab; Radiation: stereotactic body radiation therapy; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate, according to RECISTv1.1, the proportion of patients with CR or PR was determined. If the patient has not undergone a post-baseline assessment, it is considered unremission.
Measured: up to 3 years
Secondary outcomes (4)
PFS
progression-free survival (PFS) refers to the time from enrollment to the first recording of disease progression as determined by RECISTv1.1, or to death due to any cause (whichever occurs first). PFS will be analyzed in the ITT analysis set.
Measured: up to 3 years
OS
Overall survival (OS) refers to the time from enrollment to the first recorded death due to any cause (whichever occurs first).
Measured: up to 3 years
HRQoL
HRQoL uses EORTCQLQ-C30 to assess the overall health of patients. The post-baseline score of the treatment group was studied, and the score changes from the baseline were summarized descriptively.
Measured: up to 3 years
HRQoL
HRQoL uses EORTCQLQ-OES18 to assess the overall health of patients. The post-baseline score of the treatment group was studied, and the score changes from the baseline were summarized descriptively.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start21 Dec 2021
- Primary completion20 Dec 2023 (estimated)
- Study completion20 Dec 2023 (estimated)
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 Cancer MetastaticStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI TAO, Sichuan Cancer Hospital and Research Institute
- Investigators
- Tao Li, doctor, Study chair, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472467
- Sponsor's protocol ID
- SCCHEC-01-2021-091
- Acronym
- IMCORT-2
- Status last verified
- Jul 2022
- First submitted
- 21 Jul 2022
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab Combination With SBRT and Concurrent Chemotherapy Treated Stage IV Oligometastatic Non-small Cell Lung Cancer ，a Single-arm, Single-center, Exploratory Clinical Study（IMCORT-2）
- ClinicalTrials.gov ID
- NCT05472467
- Acronym / sponsor ID
- IMCORT-2 / SCCHEC-01-2021-091
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Keywords
- NSCLC,Camrelizumab,SBRT,oligometastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 25 Jul 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.
This study evaluated the effectiveness and safety of Camrelizumab combination with SBRT and concurrent chemotherapy treated stage IV oligometastatic non-small cell lung cancer
Detailed description
This study evaluated the effectiveness and safety of Camrelizumab combination with SBRT and concurrent chemotherapy treated stage IV oligometastatic non-small cell lung cancer.
The primary endpoint is ORR. Secondary points contains：PFS、OS、DCR、Qol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy combined with Stereotactic Body Radiation Therapy | Experimental | Drug: Camrelizumab, Radiation: stereotactic body radiation therapy, Drug: Chemotherapy1. Camrelizumab： 200mg IV Q3W 2. Chemotherapy：Squamous carcinoma: docetaxel 60 mg/m2, d1 + cisplatin 25 mg/m2, d1-3 or carboplatin AUC=4-6 d1, 21 days for one cycle, up to 4 cycles. Non-squamous carcinoma: pemetrexed 500 mg/m2, d1 + cisplatin 25 mg/m2, d1-3 or carboplatin AUC=4-6, d1,21 days for one cycle, up to 4 cycles. 3. Stereotactic Body Radiation Therapy(SBRT) for Oligometastatic the total dose 35Gy/5f(7.0Gy/f,5f per week)。 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- patients voluntarily enrolled in this study and signed the informed consent form (ICF).
- Good compliance and cooperation with follow-up.
- age: 18 to 75 years, both sexes.
- ECOG PS: 0 to 1 score.
- patients with non-small cell lung cancer clearly diagnosed by pathology, with measurable tumor lesions (oligometastases ≥10 mm in length, meeting mRECIST1.1 criteria).
Key exclusion criteria (19 listed)
- patients who do not meet the inclusion criteria for type of pathology and site of primary focus.
- with diffuse brain metastases and meningeal metastases
- have any active autoimmune disease or a history of autoimmune disease such as inter stromal pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after normal hormone replacement therapy).
- may be included after normalization of hormone replacement therapy).
- patients with asthma requiring medical intervention with bronchodilators
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 |
|---|---|---|
| Camrelizumab200mg IV Q3W. Every three weeks is a cycle | Drug | Immunotherapy combined with Stereotactic Body Radiation Therapy |
| stereotactic body radiation therapyAlso: SBRTstereotactic body radiation therapy for Oligometastases 35Gy/5f(7.0Gy/f,5f per week) | Radiation | Immunotherapy combined with Stereotactic Body Radiation Therapy |
| ChemotherapySquamous carcinoma: docetaxel 60 mg/m2, d1 + cisplatin 25 mg/m2, d1-3 or carboplatin AUC=4-6 d1, 21 days for one cycle, up to 4 cycles. Non-squamous carcinoma: pemetrexed 500 mg/m2, d1 + cisplatin 25 mg/m2, d1-3 or carboplatin AUC=4-6, d1,21 days for one cycle, up to 4 cycles. | Drug | Immunotherapy combined with Stereotactic Body Radiation Therapy |
Primary outcome
ORR
Time frame: up to 3 years
Objective response rate, according to RECISTv1.1, the proportion of patients with CR or PR was determined. If the patient has not undergone a post-baseline assessment, it is considered unremission.
4 secondary outcomes
PFS
Time frame: up to 3 years
OS
Time frame: up to 3 years
HRQoL
Time frame: up to 3 years
HRQoL
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Tao Li, doctor study chair
Sichuan Cancer Hospital and Research Institute
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 Camrelizumab, stereotactic body radiation therapy and Chemotherapy in people with Non-small Cell Lung Cancer Metastatic, run by Sichuan Cancer Hospital and Research Institute 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 17 inclusion and 19 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 25 Jul 2022. 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 jiahua lyu, doctor (17713539529, winlttljh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: up to 3 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 25 Jul 2022.