Non-small Cell Lung CancerNCT06503042
A Study to Prospectively Validate Blood Markers Associated With Differences in Efficacy of Neoadjuvant Therapy for NSCLC
An observational study of Non-small Cell Lung Cancer, run by Tang-Du Hospital.
Trial summary
This study utilized a prospective cohort design. It is proposed to analyze the serum of NSCLC patients treated with chemotherapy combined with immunotherapy, and chemotherapy alone, starting from liquid biopsy technique and combining with proteomic methods. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Chemotherapy combined with immunotherapy and Chemotherapy only
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Aug 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with non-small cell lung cancer undergoing neoadjuvant chemotherapy combined with immunotherapy or neoadjuvant chemotherapy at the Thoracic Surgery Department of Tang Du Hospital.
Who may be able to join
- Subjects must sign the written informed consent form (ICF), and be able to follow the visits and relevant procedures specified in the protocol
- Cytologically or histologically confirmed primary NSCLC (including adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma)
- Have not received any prior systemic anti-tumor therapy or local radiotherapy for NSCLC
- Have adequate organ and bone marrow function, and the laboratory examination values within 14 days prior to enrollment meet the following requirements (no blood components, cell growth factors, albumin and other intravenous or subcutaneously administered drugs to correct hematological or liver and kidney dysfunction were allowed within the first 14 days of obtaining laboratory tests), as follows:
- ①Hematological function was sufficient, defined as absolute neutrophil count ≥ 1.5 × 109 / L, platelet count ≥ 100 × 109 / L, hemoglobin ≥ 100g / L;
- ②Full liver function, defined as total bilirubin level ≤ 1.5 × ULN, AST and ALT level ≤ 2.5 × ULN, albumin (ALB) ≥ 35g / L;
Show all 11Show fewer
- Renal function was sufficient, serum creatinine (Scr) ≤ 1.5 × ULN, creatinine clearance rate (CrCl) ≥ 60mL / min (calculated by Cockcroft / Gault formula) and urine routine test results showed that urinary protein (UPRO) \< 2 + or 24-hour urinary protein \< 1g;
- The international normalized ratio (INR) ≤ 1.5 × ULN, and prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN within 7 days before treatment;
- For women of childbearing age, urine or serum pregnancy tests were negative for at least seven days prior to the first study drug administration. If the urine pregnancy test is positive, a blood pregnancy test is required;
- If there is a risk of conception, male and female patients need to use high-efficiency contraception (i.e., the method with an annual failure rate of less than 1 %) and continue until at least 180 days after discontinuation of the trial; Note: If abstinence is the normal lifestyle and preferred contraceptive method of the subjects, abstinence can be accepted as a contraceptive method.
- -
Who cannot join
- Pathological examination showed that small cell carcinoma, neuroendocrine carcinoma, sarcoma, lymphoepithelioma-like carcinoma, salivary gland tumor and mesenchymal tumor components
- Tumor invasion of the diaphragm, mediastinum, heart, pericardium, large blood vessels (such as aorta), esophagus, vertebral body
- pulmonary sulcus tumor
- Contralateral lung nodules, it need biopsy if clinically suspected
- Subjects with confirmed or suspected brain metastases
- Participation in an interventional clinical study or treatment with another investigational drug or investigational device within 4 weeks prior to enrollment
Show all 30Show fewer
- Previous use of anti-PD-1, anti-PD-L1, anti-programmed death receptor ligand 2 (PD-L2) or anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) drugs or any other drugs acting on T cell co-stimulation or immune checkpoint pathways (such as OX40, CD137, etc.) and adoptive cellular immunotherapy
- Received immunomodulatory drugs (including thymidine, interferon, interleukins, etc.) within the first 4 weeks of enrollment
- Live attenuated vaccine within the first 4 weeks of enrollment (or plan to receive live attenuated vaccine during the study period). Note: Inactivated seasonal influenza vaccine is permitted, but live attenuated influenza vaccine is not permitted
- Requires prolonged systemic glucocorticoid use and has received any other form of immunosuppressive therapy within 7 days prior to enrollment Note: Nasal spray, inhalation, or other topical glucocorticoid or physiologic doses of systemic glucocorticoid (≤ 10 mg/day of prednisone or equivalent) are permitted or are used for pretreatment (e.g., for prevention of contrast allergy).
- History of non-infectious pneumonia requiring glucocorticoid therapy within 1 year prior to enrollment or current interstitial lung disease (≥ grade 2)
- Active autoimmune disease including, but not limited to, inflammatory bowel disease such as ulcerative colitis or Crohn's disease requiring systemic therapy (e.g., use of disease modifying medications, corticosteroids, or immunosuppressive drugs) within the 2 years prior to enrollment Diverticulitis, celiac disease, systemic lupus erythematosus, sarcoidosis-like or Wegener's syndrome (granulomatous polyangiitis), Graves' disease, rheumatoid arthritis, multiple sclerosis, vasculitis, glomerulonephritis rheumatoid arthritis, multiple sclerosis, vasculitis, glomerulonephritis, antiphospholipid syndrome, pituitary gland inflammation, and uveitis. Replacement therapies (e.g., thyroxine, insulin, or physiologic doses of corticosteroids for adrenal or pituitary dysfunction) are not considered systemic therapy. Patients with positive autoimmune antibodies will be enrolled only after evaluation by the investigator to confirm that there are no autoimmune diseases requiring systemic therapy.
- Primary immunodeficiency diseases
- Pre-existing or current myocarditis
- incomplete recovery from toxicity and/or complications resulting from any intervention prior to enrollment (> grade 1 or not recovered to baseline levels)
- Peripheral neuropathy ≥ grade 2
- Hereditary predisposition to bleeding or coagulation disorders, or history of thrombosis: Any arterial thrombosis, embolism, or ischemia such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, or pulmonary embolism within 6 months prior to enrollment. History of deep vein thrombosis or any other serious thromboembolism within 3 months prior to enrollment (implantable venous access ports or catheter-derived thrombosis or superficial vein thrombosis are not considered thromboembolism).
- Subjects with non-squamous NSCLC who are unable or unwilling to supplement with folic acid or vitamin B12
- Any unstable systemic disease or complication, including but not limited to 1) active infection (requiring anti-infective medications or systemic anti-infective medications within one week prior to randomization); 2) congestive heart failure [New York Heart Association, NYHA ≥ Class II]; 3) severe cardiac arrhythmia, hepatic, renal, or metabolic disorders requiring medication; 4) untreated atherosclerotic heart disease of the coronary arteries; 5) history of gastrointestinal perforation and/or fistulae (5) History of gastrointestinal perforation and/or fistula; (6) History of intestinal obstruction, extensive bowel resection or chronic diarrhea within the past 6 months.
- Solid organ or blood system transplantation.
- Have a history of HIV infection (HIV1/2 antibody positive), active syphilis
- Tuberculosis, which is active or requires medical intervention at this stage, including but not limited to pulmonary tuberculosis
- Active Hepatitis B Subjects with hepatitis B who met the following criteria met the inclusion criteria: HBsAg (+) or HBcAb (+), HBV viral load \< 2000 copies/ml or \< 200 IU/ml or lower than the detection limit HBsAg Subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-) do not need to receive prophylactic anti-HBV treatment, but need to closely monitor whether the virus is reactivated
- Active hepatitis C (HCV antibody positive and HCV-RNA level above the detection limit)
- patients with malignancies other than diagnosed NSCLC within the first 5 years of enrollment, with the exception of fully treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, and papillary thyroid cancer after radical therapy
- Hypersensitivity to the active ingredient(s) and/or any excipient(s) of the chemotherapeutic or immunotherapeutic regimen.
- Pregnant or lactating women or women who intend to become pregnant or breastfeed during the study period
- Subjects with mental illness or substance abuse that may interfere with compliance with trial requirements and a history of alcohol abuse
- non-malignant tumors due to localized or systemic disease, or secondary reactions to cancer, that can lead to higher medical risk and/or uncertainty in survival assessment, in the opinion of the investigator, caused by the subject having a medical history, disease, treatment, or laboratory abnormality that may interfere with the results of the trial, that prevents the subject from participating in the study in its entirety, or in the opinion of the investigator, that the subject will not receive optimal benefit from the study.
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Study to Prospectively Validate Blood Markers Associated With Differences in Efficacy of Neoadjuvant Therapy for Non-small Cell Lung Cancer
This study utilized a prospective cohort design. It is proposed to analyze the serum of NSCLC patients treated with chemotherapy combined with immunotherapy, and chemotherapy alone, starting from liquid biopsy technique and combining with proteomic methods. By comparing the differences in serum proteins between the two groups of patients before treatment, we will validate the targets related to efficacy and AE events identified in a previous retrospective study, further explore their associations with patients' clinical outcomes and AE events, and establish a clinical prediction model to guide and improve the current treatment of NSCLC.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Chemotherapy combined with immunotherapy, Chemotherapy only
- 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.
Chemotherapy combined with immunotherapyDrug
Patients in the chemotherapy combined with immunotherapy group use any chemotherapy drug in combination with any immunotherapy drug. The premise is that the treatment regimen for patients is consistent with the diagnostic and treatment protocols.
Chemotherapy onlyDrug
Patients in the chemotherapy alone group use any chemotherapy drug. The premise is that the treatment regimen for patients is consistent with the diagnostic and treatment protocols.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy combined with immunotherapy group | NSCLC patients undergoing neoadjuvant chemotherapy combined with immunotherapy regimens Receives: Drug: Chemotherapy combined with immunotherapy | |
| Chemotherapy group | NSCLC patients undergoing neoadjuvant chemotherapy regimens Receives: Drug: Chemotherapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR rate
rate of pathological complete response
Measured: 4 months
MPR rate
rate of major pathologic response
Measured: 4 months
Secondary outcomes (1)
AE
Adverse Event
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (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 CancerStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503042
- Sponsor's protocol ID
- K202407-07
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 16 Jul 2024
- 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 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Prospectively Validate Blood Markers Associated With Differences in Efficacy of Neoadjuvant Therapy for Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06503042
- Acronym / sponsor ID
- K202407-07
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 16 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 study utilized a prospective cohort design. It is proposed to analyze the serum of NSCLC patients treated with chemotherapy combined with immunotherapy, and chemotherapy alone, starting from liquid biopsy technique and combining with proteomic methods. By comparing the differences in serum proteins between the two groups of patients before treatment, we will validate the targets related to efficacy and AE events identified in a previous retrospective study, further explore their associations with patients' clinical outcomes and AE events, and establish a clinical prediction model to guide and improve the current treatment of NSCLC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy combined with immunotherapy group | – | Drug: Chemotherapy combined with immunotherapyNSCLC patients undergoing neoadjuvant chemotherapy combined with immunotherapy regimens |
| Chemotherapy group | – | Drug: Chemotherapy onlyNSCLC patients undergoing neoadjuvant chemotherapy regimens |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with non-small cell lung cancer undergoing neoadjuvant chemotherapy combined with immunotherapy or neoadjuvant chemotherapy at the Thoracic Surgery Department of Tang Du Hospital.
Key inclusion criteria (11 listed)
- Subjects must sign the written informed consent form (ICF), and be able to follow the visits and relevant procedures specified in the protocol
- Cytologically or histologically confirmed primary NSCLC (including adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma)
- Have not received any prior systemic anti-tumor therapy or local radiotherapy for NSCLC
- Have adequate organ and bone marrow function, and the laboratory examination values within 14 days prior to enrollment meet the following requirements (no blood components, cell growth factors, albumin and other intravenous or subcutaneously administered drugs to correct hematological or liver and kidney dysfunction were allowed within the first 14 days of obtaining laboratory tests), as follows:
- ①Hematological function was sufficient, defined as absolute neutrophil count ≥ 1.5 × 109 / L, platelet count ≥ 100 × 109 / L, hemoglobin ≥ 100g / L;
Key exclusion criteria (30 listed)
- Pathological examination showed that small cell carcinoma, neuroendocrine carcinoma, sarcoma, lymphoepithelioma-like carcinoma, salivary gland tumor and mesenchymal tumor components
- Tumor invasion of the diaphragm, mediastinum, heart, pericardium, large blood vessels (such as aorta), esophagus, vertebral body
- pulmonary sulcus tumor
- Contralateral lung nodules, it need biopsy if clinically suspected
- Subjects with confirmed or suspected brain metastases
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 |
|---|---|---|
| Chemotherapy combined with immunotherapyPatients in the chemotherapy combined with immunotherapy group use any chemotherapy drug in combination with any immunotherapy drug. The premise is that the treatment regimen for patients is consistent with the diagnostic and treatment protocols. | Drug | Chemotherapy combined with immunotherapy group |
| Chemotherapy onlyPatients in the chemotherapy alone group use any chemotherapy drug. The premise is that the treatment regimen for patients is consistent with the diagnostic and treatment protocols. | Drug | Chemotherapy group |
Primary outcome
pCR rate
Time frame: 4 months
rate of pathological complete response
MPR rate
Time frame: 4 months
rate of major pathologic response
1 secondary outcome
AE
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Non-small Cell Lung Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
RecruitingPhase 3
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
Non-small Cell Lung Cancer
Recruiting
Understanding the Feasibility of a Co-designed Pre-radiotherapy Exercise Programme - A Single-arm Study
Lung Cancer
RecruitingPhase 2
Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E)
Non-small Cell Lung Cancer, Non-small Cell Lung Cancer Stage I
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by Tang-Du Hospital.
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 11 inclusion and 30 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 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Tao Jiang (8613572592311, jiangtao@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR rate (time frame: 4 months). The study lists 2 primary outcomes in all. 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 16 Jul 2024.