Non-small Cell Lung CancerPhase 2NCT05360979
A Clinical Study of Immunotherapy Combined With Chemotherapy and Anti-angiogenic Therapy in Operable NSCLC
A Phase 2 study testing envafolimab in people with Non-small Cell Lung Cancer, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The objective of this prospective, single-arm, single-center clinical study is to evaluate the efficacy and safety of envafolimab combined with platinum-containing dual-drug chemotherapy and recombinant human endostatin regimens for treating patients with operable II, IIIA, and IIIB (T3N2) stage NSCLC. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- envafolimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2022to 15 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all following inclusion criteria to be eligible for study entry:
- The subjects fully understand the research and voluntarily sign the informed consent form (ICF);
- Subjects are aged between 18 to 70 years, irrespective of gender;
- Patients with resectable stage II, stage IIIA, and stage IIIB (T3N2) (AJCC staging 8th edition) NSCLC with no prior treatment and confirmed by histology; TNM staging can be confirmed by positron emission tomography (PET)-computed tomography (CT) or pathological biopsy;
- The presence of measurable lesions according to version 1.1 of the evaluation standard for the efficacy of solid tumors;
- Tumor tissue specimens can be submitted for pathological diagnosis, programmed death-ligand 1 (PD-L1) expression, and biomarker detection before enrollment (tumor tissues must be fresh specimens or archived samples obtained within three months before enrollment; tumor tissue specimen must be histological samples, including, but not limited to, puncture tissues obtained by thick and hollow needles, tissues obtained by bronchoscope clamps, or surgical removal samples. Puncture tissues obtained by fine needles and samples obtained by bronchial brushing are unacceptable);
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- Eastern Cooperative Oncology Group (ECOG) score 0-1;
- Good organ function;
- Hematology: Absolute neutrophil count (ANC) ≥ 1500/μL; platelets ≥ 100000/μL; hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L;
- Kidney: Serum creatinine ≤ 1.5× upper limit of normal (ULN) or calculated creatinine clearance rate (CrCl) ≥ 60 mL/min (using Cock-Gault formula);
- Liver: total bilirubin ≤ 1.5 × ULN or for subjects with total bilirubin level > 1.5 × ULN, direct bilirubin within normal limits; Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase [SGPT]) ≤ 2.5 × ULN;
- Endocrine system: Thyroid-stimulating hormone (TSH) is within normal limits. Note: If TSH is not within the normal range at baseline, and if T3 and free T4 are within the normal range, then the subject can be considered to meet inclusion criteria; Coagulation function: international normalized ratio (INR) or prothrombin time (PT), activation partial thromboplastin time (aPTT) ≤ 1.5 × ULN, except for cases: subjects who are receiving anticoagulant therapy, if the PT or aPTT is within the intended use range of anticoagulant drugs;
- Patients are willing and able to comply with the research plan's visits, treatment plans, laboratory examinations, and other research procedures;
- According to the assessment of the surgeon, the total lung function can withstand the planned lung resection;
- Women of childbearing age must undergo a serum pregnancy test within 3 days before the first treatment, and the result should be negative. Female subjects of childbearing age and male subjects whose partners are women of childbearing age must agree to use high-efficiency methods of contraception during the study and within 180 days after the last administration of the study drug.
Who cannot join
- 1. Presence of unresectable or metastatic disease; 2. Subjects with NSCLC, large cell neuroendocrine carcinoma (LCNEC), sarcomatoid tumors involving the upper sulcus; subjects with non-squamous NSCLC with known EGFR (epidermal growth factor receptor) mutations or ALK translocations; 3. Subjects with early-stage NSCLC who previously received systemic anticancer treatment, including experimental drug treatment; subjects with a history of (non-infectious) pneumonia/interstitial lung disease that requires steroid treatment, or currently present pneumonia/interstitial disease that requires steroid treatment pulmonary disease; 4. Subjects with a history of active tuberculosis; 5. Subjects with active infections requiring systemic treatment; 6. Subjects with known or suspected autoimmune diseases or immunodeficiency, except for patients with a history of hypothyroidism who do not need hormone therapy or are receiving physiological dose hormone replacement therapy; subjects with stable type I diabetes with controlled blood sugar levels; 7. Subjects with uncontrolled active hepatitis B (defined as a positive test result for hepatitis B virus surface antigen [HBsAg] during the screening period, and the detection value of HBV-DNA exceeds the ULN value of the laboratory department of the research center); (Subjects whose HBV-DNA content <500 IU/mL tested within 28 days before enrollment, and have received at least 14 days of local standard antiviral therapy and are willing to continue to receive antiviral therapy during the study period can be included); Subjects with active hepatitis C (defined as a positive test result of hepatitis C virus surface antibody [HCsAb] and HCV-RNA positive during the screening period); 8. Known human immunodeficiency virus (HIV) infection (known HIV antibody positive); 9. Subjects vaccinated with a live vaccine within 30 days before the first administration, including, but not limited to, the following: mumps, rubella, measles, chickenpox/shingles (chickenpox), yellow fever, rabies, Bacille Calmette-Guerin (BCG) and typhoid vaccine (inactivated virus vaccine allowed); 10. Subjects who previously received PD-1/PD-L1 drug treatment or treatment of another drug targeting T cell receptors (such as CTLA-4 and OX-40); 11. Subjects who have had a severe allergic reaction to other monoclonal antibodies; 12. Subjects who have a history of severe allergies to pemetrexed, paclitaxel or albumin paclitaxel or docetaxel, cisplatin, carboplatin, recombinant human endostatin active ingredients, or preventive medications; 13. Subjects who are known to have serious or uncontrolled underlying diseases; 14. Subjects presenting malignant tumors other than NSCLC within 5 years before the first administration. Malignant tumors with negligible risk of metastasis or death (e.g., expected DFS> 5 years) and expected curative results after treatment (e.g., fully treated cervical carcinoma in situ, basal or squamous cell skin cancer, radical surgery treated ductal carcinoma in situ) can be excluded.
- 15. Subjects with grade III-IV congestive heart failure (New York Heart Association classification) and poorly controlled and clinically significant arrhythmia; 16. Subjects who have experienced any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months before selection for treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single-arm Clinical Study of Envafolimab Combined With Chemotherapy and Recombinant Human Endostatin in Patients With Operable Stage II, IIIA, and IIIB (T3N2) Non-small Cell Lung Cancer
The objective of this prospective, single-arm, single-center clinical study is to evaluate the efficacy and safety of envafolimab combined with platinum-containing dual-drug chemotherapy and recombinant human endostatin regimens for treating patients with operable II, IIIA, and IIIB (T3N2) stage NSCLC.
Read the detailed description
Patients with stage II, IIIA, and IIIB (T3N2) NSCLC that did not previously receive systemic treatment and can be treated with surgery were recruited. After signing the informed consent, eligible subjects who meet the inclusion criteria will receive neoadjuvant therapy comprising envafolimab combined with platinum-containing chemotherapy and recombinant human endostatin, as well as postoperative envafolimab single-agent adjuvant therapy.
During the preoperative neoadjuvant therapy period, 3 cycles of envafolimab (300 mg fixed-dose Q3W) with recombinant human endostatin (210 mg, CIV [continuous intravenous pump injection], 72 h, Q3W), and platinum-containing dual-drug chemotherapy (Q3W) will be performed, with a dosing cycle performed every 3 weeks. The study drug will be administered on the first day of each cycle.
All subjects will undergo preoperative imaging evaluation and surgical indication evaluation at 3-5 weeks after the third cycle of preoperative medication.
After completing the first 3 cycles of neoadjuvant therapy, all subjects persistently presenting indications for surgery will undergo radical surgery for NSCLC within 4-6 weeks according to the standards defined by the World Association for the Study of Lung Cancer. The pathological staging will be performed according to the AJCC Cancer Staging Manual (8th edition). Local pathologists will evaluate the surgical margins of all specimens removed during the operation. Tumor tissue samples collected from subjects during the research process will be submitted to the designated central laboratory for pathological remission assessment and translational research.
Postoperative envafolimab monotherapy (300 mg, Q3W) will be initiated at 4-6 weeks post-surgery and maintained for 1 year Adverse events (AE) will be monitored throughout the study period, and the severity of AEs will be assessed according to the guidelines listed in the National Cancer Institute (NCI) Commonly Used Terminology Criteria for Adverse Events (CTCAE) version 5.0 or above. Safety follow-ups will be conducted for all patients receiving treatment and those who warrant early discontinuation. All subjects will be followed up for OS until death, withdrawal of informed consent, or the end of the study.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- envafolimab
- 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.
envafolimabDrug
Also called recombinant human endostatin, chemotherapy
Envafolimab: 300 mg, D1, Q3W, subcutaneously administered
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant and adjuvant therapy | Experimental | After signing the informed consent, eligible subjects who meet the inclusion criteria will receive neoadjuvant therapy comprising envafolimab combined with platinum-containing chemotherapy and recombinant human endostatin, as well as postoperative envafolimab single-agent adjuvant therapy. Receives: Drug: envafolimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
MPR rate
Major pathological reaction (MPR), defined as remaining viable tumor cells ≤ 10% at surgical resection of the primary tumor.MPR rate, defined as the proportion of intention-to-treat (ITT) population reaching MPR.
Measured: 0-36months
Secondary outcomes (5)
the event-free survival (EFS)
Event-free lifetime (EFS), defined as the time from the beginning of group entry to the occurrence of any of the following events
Measured: 0-36months
the complete pathological remission rate (pCR)
pCR, defined as the absence of any surviving primary tumor cells on surgical removal of the primary tumor.
Measured: 0-36months
the disease-free survival (DFS)
DFS, defined as the time from enrollment to local or distant recurrence (including the occurrence of new primary NSCLC) or death from any cause, whichever occurs first.
Measured: 0-36months
the 3-year survival rate and overall survival (OS)
OS, defined as the time from treatment to the death of the subject due to any cause.
Measured: 0-36months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, AEs, TEAEs, SAEs,irAEs
The incidence and severity of all AEs, treatment-emergent AEs (TEAEs), serious AEs (SAEs), and immune-related AEs (irAEs), and their correlation with study drugs.
Measured: 0-36months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start15 May 2022 (estimated)
- Primary completion15 May 2023 (estimated)
- Study completion15 May 2025 (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.
- More trials run by Second Xiangya Hospital of Central South 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xianling liu, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360979
- Sponsor's protocol ID
- NSCLC-LXL002
- Status last verified
- May 2022
- First submitted
- 26 Dec 2021
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- 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 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm Clinical Study of Envafolimab Combined With Chemotherapy and Recombinant Human Endostatin in Patients With Operable Stage II, IIIA, and IIIB (T3N2) Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05360979
- Acronym / sponsor ID
- NSCLC-LXL002
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 15 May 2022 (estimated)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 4 May 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 objective of this prospective, single-arm, single-center clinical study is to evaluate the efficacy and safety of envafolimab combined with platinum-containing dual-drug chemotherapy and recombinant human endostatin regimens for treating patients with operable II, IIIA, and IIIB (T3N2) stage NSCLC.
Detailed description
Patients with stage II, IIIA, and IIIB (T3N2) NSCLC that did not previously receive systemic treatment and can be treated with surgery were recruited. After signing the informed consent, eligible subjects who meet the inclusion criteria will receive neoadjuvant therapy comprising envafolimab combined with platinum-containing chemotherapy and recombinant human endostatin, as well as postoperative envafolimab single-agent adjuvant therapy.
During the preoperative neoadjuvant therapy period, 3 cycles of envafolimab (300 mg fixed-dose Q3W) with recombinant human endostatin (210 mg, CIV [continuous intravenous pump injection], 72 h, Q3W), and platinum-containing dual-drug chemotherapy (Q3W) will be performed, with a dosing cycle performed every 3 weeks. The study drug will be administered on the first day of each cycle.
All subjects will undergo preoperative imaging evaluation and surgical indication evaluation at 3-5 weeks after the third cycle of preoperative medication.
After completing the first 3 cycles of neoadjuvant therapy, all subjects persistently presenting indications for surgery will undergo radical surgery for NSCLC within 4-6 weeks according to the standards defined by the World Association for the Study of Lung Cancer. The pathological staging will be performed according to the AJCC Cancer Staging Manual (8th edition). Local pathologists will evaluate the surgical margins of all specimens removed during the operation. Tumor tissue samples collected from subjects during the research process will be submitted to the designated central laboratory for pathological remission assessment and translational research.
Postoperative envafolimab monotherapy (300 mg, Q3W) will be initiated at 4-6 weeks post-surgery and maintained for 1 year Adverse events (AE) will be monitored throughout the study period, and the severity of AEs will be assessed according to the guidelines listed in the National Cancer Institute (NCI) Commonly Used Terminology Criteria for Adverse Events (CTCAE) version 5.0 or above. Safety follow-ups will be conducted for all patients receiving treatment and those who warrant early discontinuation. All subjects will be followed up for OS until death, withdrawal of informed consent, or the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant and adjuvant therapy | Experimental | Drug: envafolimabAfter signing the informed consent, eligible subjects who meet the inclusion criteria will receive neoadjuvant therapy comprising envafolimab combined with platinum-containing chemotherapy and recombinant human endostatin, as well as postoperative envafolimab single-agent adjuvant therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects must meet all following inclusion criteria to be eligible for study entry:
Key exclusion criteria (2 listed)
- 1. Presence of unresectable or metastatic disease; 2. Subjects with NSCLC, large cell neuroendocrine carcinoma (LCNEC), sarcomatoid tumors involving the upper sulcus; subjects with non-squamous NSCLC with known EGFR (epidermal growth factor receptor) mutations or ALK translocations; 3. Subjects with early-stage NSCLC who previously received systemic anticancer treatment, including experimental drug treatment; subjects with a history of (non-infectious) pneumonia/interstitial lung disease that requires steroid treatment, or currently present pneumonia/interstitial disease that requires steroid treatment pulmonary disease; 4. Subjects with a history of active tuberculosis; 5. Subjects with active infections requiring systemic treatment; 6. Subjects with known or suspected autoimmune diseases or immunodeficiency, except for patients with a history of hypothyroidism who do not need hormone therapy or are receiving physiological dose hormone replacement therapy; subjects with stable type I diabetes with controlled blood sugar levels; 7. Subjects with uncontrolled active hepatitis B (defined as a positive test result for hepatitis B virus surface antigen [HBsAg] during the screening period, and the detection value of HBV-DNA exceeds the ULN value of the laboratory department of the research center); (Subjects whose HBV-DNA content <500 IU/mL tested within 28 days before enrollment, and have received at least 14 days of local standard antiviral therapy and are willing to continue to receive antiviral therapy during the study period can be included); Subjects with active hepatitis C (defined as a positive test result of hepatitis C virus surface antibody [HCsAb] and HCV-RNA positive during the screening period); 8. Known human immunodeficiency virus (HIV) infection (known HIV antibody positive); 9. Subjects vaccinated with a live vaccine within 30 days before the first administration, including, but not limited to, the following: mumps, rubella, measles, chickenpox/shingles (chickenpox), yellow fever, rabies, Bacille Calmette-Guerin (BCG) and typhoid vaccine (inactivated virus vaccine allowed); 10. Subjects who previously received PD-1/PD-L1 drug treatment or treatment of another drug targeting T cell receptors (such as CTLA-4 and OX-40); 11. Subjects who have had a severe allergic reaction to other monoclonal antibodies; 12. Subjects who have a history of severe allergies to pemetrexed, paclitaxel or albumin paclitaxel or docetaxel, cisplatin, carboplatin, recombinant human endostatin active ingredients, or preventive medications; 13. Subjects who are known to have serious or uncontrolled underlying diseases; 14. Subjects presenting malignant tumors other than NSCLC within 5 years before the first administration. Malignant tumors with negligible risk of metastasis or death (e.g., expected DFS> 5 years) and expected curative results after treatment (e.g., fully treated cervical carcinoma in situ, basal or squamous cell skin cancer, radical surgery treated ductal carcinoma in situ) can be excluded.
- 15. Subjects with grade III-IV congestive heart failure (New York Heart Association classification) and poorly controlled and clinically significant arrhythmia; 16. Subjects who have experienced any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months before selection for treatment.
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 |
|---|---|---|
| envafolimabAlso: recombinant human endostatin, chemotherapyEnvafolimab: 300 mg, D1, Q3W, subcutaneously administered | Drug | Neoadjuvant and adjuvant therapy |
Primary outcome
MPR rate
Time frame: 0-36months
Major pathological reaction (MPR), defined as remaining viable tumor cells ≤ 10% at surgical resection of the primary tumor.MPR rate, defined as the proportion of intention-to-treat (ITT) population reaching MPR.
5 secondary outcomes
the event-free survival (EFS)
Time frame: 0-36months
the complete pathological remission rate (pCR)
Time frame: 0-36months
the disease-free survival (DFS)
Time frame: 0-36months
the 3-year survival rate and overall survival (OS)
Time frame: 0-36months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, AEs, TEAEs, SAEs,irAEs
Time frame: 0-36months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 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.
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 envafolimab in people with Non-small Cell Lung Cancer, run by Second Xiangya Hospital of Central South 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 15 inclusion and 2 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 4 May 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?
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?
MPR rate (time frame: 0-36months). 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 4 May 2022.