Non-Small-Cell LungPhase 2NSCLCNCT05465733
First-line Replacement Maintenance of Envafolimab in Advanced NSCLC
A Phase 2 study testing Envafolimab;Pemetrexed in people with Non-Small-Cell Lung, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
This study is a single-center, prospective, single-arm phase II clinical study. For newly-treated patients with advanced NSCLC with negative driver gene and positive PD-L1 expression, those patients who did not progress after 4-6 cycles of PD-1 or PD-1 combined with chemotherapy standard treatment, after signing the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small-Cell Lung
- What is being tested?
- Envafolimab;Pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 30 Jun 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
- The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up;
- Age 18-75 years old;
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC);
- Patients with non-small cell lung cancer (NSCLC) who have received PD-1 or PD-1 combined with chemotherapy and have not progressed in previous first-line therapy;
- According to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1), at least one lesion that can be measured by imaging. Lesions located in the field of previous radiotherapy can be regarded as measurable lesions if they are confirmed to have progressed;
- An archived tumor tissue sample or newly obtained (no anti-tumor therapy since biopsy) core or tumor foci (no prior radiotherapy) excisional biopsy has been provided. Formalin-fixed and paraffin-embedded (FFPE) tissue blocks are preferred over sections. The newly obtained biopsy tissue is superior to the archived tissue, and the tissue sample is detected by immunohistochemistry for PD-L1 ≥ 1%;
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- ECOG score 0-1 points;
- Expected survival time ≥ 3 months;
- Sufficient organ function, subjects should meet the following laboratory indicators:
- The absolute value of neutrophils (ANC) is ≥1.5x109/L without the use of granulocyte colony-stimulating factor in the past 14 days; (2) Platelets ≥100×109/L without platelet transfusion or thrombopoietin use in the past 14 days; (3) Hemoglobin>9g/dL without blood transfusion or erythropoietin in the past 14 days; (4) Total bilirubin ≤ 1.5 × upper limit of normal (ULN); or total bilirubin > ULN but direct bilirubin ≤ ULN (5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are ≤2.5×ULN (patients with liver metastases are allowed ALT or AST ≤5×ULN); (6) Serum creatinine ≤1.5×ULN and creatinine clearance rate (calculated by Cockcroft-Gault formula) ≥60 ml/min; (7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; for patients receiving anticoagulation therapy, PT/INR is within the required treatment criteria; (8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; (9) Myocardial enzyme spectrum is within the normal range (if the investigators comprehensively judge that the simple laboratory abnormality does not have clinical significance, it is also allowed to be included in the group); 10. For female subjects of childbearing age, a negative urine or serum pregnancy test should be performed within 3 days prior to receiving the first dose of study drug (Day 1 of Cycle 1). If a urine pregnancy test result cannot be confirmed negative, a blood pregnancy test is required. Women of non-reproductive age are defined as having been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy; 11.If there is a risk of conception, all subjects (whether male or female) are required to use an annual failure rate of less than 1 throughout the treatment period up to 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy drug) % of contraception.
Who cannot join
- Patients with known EGFR sensitive mutations or ALK rearrangements;
- Patients who have received first-line standard treatment and progressed in the past;
- Subjects with active central nervous system (CNS) metastasis, if the subject's CNS metastasis can be adequately treated, and the subject's neurological symptoms can return to baseline levels at least 2 weeks before enrollment treatment-related residual signs or symptoms), can participate in the study. In addition, the subject must also be a corticosteroid-free subject or receive a stable or tapering dose of ≤10 mg/day of prednisone (or equivalent);
- Received systemic systemic treatment of Chinese patent medicines with anti-lung cancer indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for controlling pleural effusion) within 2 weeks before the first administration;
- Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational device treatment within 4 weeks before the first dose;
- Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants) has occurred within 2 years before the first dose. Replacement therapy (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy;
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- Are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study; Note: Physiological doses of glucocorticoids (≤10 mg/day prednisone or equivalent) are allowed;
- Those who are known to be allergic to the active ingredients or excipients of the study drugs such as envolimab and pemetrexed;
- Pregnant or lactating women;
- Has not sufficiently recovered from toxicity and/or complications from any intervention (ie, ≤ Grade 1 or reached baseline, excluding fatigue or alopecia) prior to initiating treatment;
- Known history of human immunodeficiency virus (HIV) infection (ie HIV 1/2 antibody positive);
- Untreated active hepatitis B (defined as HBsAg positive and the detection of HBV-DNA copy number greater than the upper limit of the normal value of the laboratory department of the research center);
- Note: Hepatitis B subjects who meet the following criteria can also be enrolled:
- HBV viral load <1000 copies/ml (200 IU/ml) before the first dose, subjects should receive anti-HBV therapy throughout the study treatment period to avoid viral reactivation;
- For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBV treatment is not required, but viral reactivation needs to be closely monitored; 13. Active HCV infected subjects (HCV antibody positive and HCV-RNA level higher than the detection limit); 14. Received live vaccine within 30 days before the first dose (cycle 1, day 1); Note: Injected inactivated virus vaccine against seasonal influenza within 30 days prior to the first dose is permitted; however, intranasal live attenuated influenza vaccine is not permitted.
- 15. Presence of any serious or uncontrolled systemic disease such as:
- There are significant abnormalities in the rhythm, conduction or morphology of the resting ECG, and the symptoms are severe and difficult to control, such as complete left bundle branch block, second-degree heart block, ventricular arrhythmia or atrial fibrillation;
- Unstable angina pectoris, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) classification ≥ grade 2;
- Myocardial infarction occurred within 6 months before enrollment;
- Unsatisfactory blood pressure control (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg);
- There is a history of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before the first administration, or there is currently clinically active interstitial lung disease;
- Active pulmonary tuberculosis;
- There is an active or uncontrolled infection that requires systemic treatment;
- Clinically active diverticulitis, abdominal abscess, and gastrointestinal obstruction;
- Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
- Poor control of diabetes (fasting blood glucose (FBG) > 10mmol/L);
- Urine routine indicates urine protein ≥++, and 24-hour urine protein quantification >1.0 g;
- Patients with mental disorders and unable to cooperate with treatment; 16. Medical history or disease evidence, abnormal treatment or laboratory test values that may interfere with the results of the trial, prevent the subjects from participating in the research throughout the study, or the investigator considers other circumstances that are not suitable for inclusion or have other potential risks and are not suitable to participate in this research. .
Trial locations and contacts
1 site in 1 country.
Xiao Fu contact
China1 site
The First Affiliated Hospital of Xian Jiaotong University
Xi’an, Shanxi, 710061
Yu Yao, PHD, 0086-85324600
About this study
Official title: A Prospective, Single-arm, Single-center Clinical Trial of Envafolimab as First-line Replacement Maintenance in Advanced NSCLC
This study is a single-center, prospective, single-arm phase II clinical study. For newly-treated patients with advanced NSCLC with negative driver gene and positive PD-L1 expression, those patients who did not progress after 4-6 cycles of PD-1 or PD-1 combined with chemotherapy standard treatment, after signing the informed consent form, were screened to meet the criteria for inclusion and exclusion. Standard, will receive Envafolimab combined with chemotherapy/Envafolimab single-agent first-line maintenance therapy until disease progression, withdrawal of informed consent, initiation of other anti-tumor therapy, death, or other protocol-specified conditions that should be discontinued Circumstances, whichever occurs first.
- Conditions
- Non-Small-Cell Lung
- Being tested
- Envafolimab;Pemetrexed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Envafolimab;PemetrexedDrug
single agent, 300mg Q3W IH until disease progressed,The duration of treatment with Envafolimab should not exceed 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Envafolimab | Experimental | Not described Receives: Drug: Envafolimab;Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
time from the randomization to the first disease progression or death
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 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 LungStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465733
- Sponsor's protocol ID
- No.XJTU1AF2022LSK-263
- Acronym
- NSCLC
- Status last verified
- Mar 2022
- First submitted
- 17 Jul 2022
- Last updated
- 20 Jul 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 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Single-center Clinical Trial of Envafolimab as First-line Replacement Maintenance in Advanced NSCLC
- ClinicalTrials.gov ID
- NCT05465733
- Acronym / sponsor ID
- NSCLC / No.XJTU1AF2022LSK-263
- Conditions
- Non-Small-Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 20 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 is a single-center, prospective, single-arm phase II clinical study. For newly-treated patients with advanced NSCLC with negative driver gene and positive PD-L1 expression, those patients who did not progress after 4-6 cycles of PD-1 or PD-1 combined with chemotherapy standard treatment, after signing the informed consent form, were screened to meet the criteria for inclusion and exclusion. Standard, will receive Envafolimab combined with chemotherapy/Envafolimab single-agent first-line maintenance therapy until disease progression, withdrawal of informed consent, initiation of other anti-tumor therapy, death, or other protocol-specified conditions that should be discontinued Circumstances, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Envafolimab | Experimental | Drug: Envafolimab;Pemetrexed |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up;
- Age 18-75 years old;
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC);
- Patients with non-small cell lung cancer (NSCLC) who have received PD-1 or PD-1 combined with chemotherapy and have not progressed in previous first-line therapy;
- According to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1), at least one lesion that can be measured by imaging. Lesions located in the field of previous radiotherapy can be regarded as measurable lesions if they are confirmed to have progressed;
Key exclusion criteria (28 listed)
- Patients with known EGFR sensitive mutations or ALK rearrangements;
- Patients who have received first-line standard treatment and progressed in the past;
- Subjects with active central nervous system (CNS) metastasis, if the subject's CNS metastasis can be adequately treated, and the subject's neurological symptoms can return to baseline levels at least 2 weeks before enrollment treatment-related residual signs or symptoms), can participate in the study. In addition, the subject must also be a corticosteroid-free subject or receive a stable or tapering dose of ≤10 mg/day of prednisone (or equivalent);
- Received systemic systemic treatment of Chinese patent medicines with anti-lung cancer indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for controlling pleural effusion) within 2 weeks before the first administration;
- Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational device treatment within 4 weeks before the first dose;
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 |
|---|---|---|
| Envafolimab;Pemetrexedsingle agent, 300mg Q3W IH until disease progressed,The duration of treatment with Envafolimab should not exceed 2 years. | Drug | Envafolimab |
Primary outcome
progression free survival
Time frame: 3-year
time from the randomization to the first disease progression or death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 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.
Xiao Fu contact
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;Pemetrexed in people with Non-Small-Cell Lung, run by First Affiliated Hospital Xi'an Jiaotong 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 10 inclusion and 28 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 20 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 Yu Yao, PhD (029-85324600, yaoyu123@xjtufh.edu.cn), 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: 3-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 20 Jul 2022.