Advanced Non-squamous Non-small-cell Lung CancerPhase 4NCT03792503
Pemetrexed Plus Apatinib Maintenance Treatment in Patients With Non-squamous Non-small Cell Lung Cancer Patients Who Have Not Progressed After 4 Cycles of Induction Chemotherapy of Pemetrexed in Combination With Platinum-based Regimen
A Phase 4 study testing Apatinib and Pemetrexed in people with Advanced Non-squamous Non-small-cell Lung Cancer, run by Xinqiao Hospital of Chongqing at 1 site in China.
Trial summary
In order to further improve the therapeutic efficacy of advanced no-squamous non-small cell lung cancer patients, improve the life cycle, this study will take the standard after treatment pemetrexed combined other anti-angiogenesis drugs to maintain as the direction, so as to provide more over the evidence for the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Non-squamous Non-small-cell Lung Cancer
- What is being tested?
- Apatinib and Pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Feb 2019to Feb 2022
- Phase
- Phase 4
- 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
- Stage IV non-squamous non-small cell lung cancer diagnosed by pathology.
- At least one measurable lesion.
- If the genetic test (EGFR/ALK) is an EGFR-sensitive mutation or an ALK fusion gene-positive patient, it is necessary to receive targeted therapy for the first-line treatment; if there is no mutation, it is necessary to be a first-line patient.
- Pemetrexed combined platinum induction chemotherapy after 4 cycles of RECIST curative effect evaluation of patients who were not progress.
- Gender is not limited, age: ≥ 18 years old.
- ECOG PS: 0-2 points.
Show all 12Show fewer
- Estimated lifetime ≥3 months
- Organ function levels meet the following criteria:
- Blood routine examination standards must meet: ANC≥1.5×109/L, PLT≥100×109/L, Hb≥100g/L (No blood transfusion and blood products within 14 days, not corrected by G-CSF and other hematopoietic stimulating factors).
- Biochemical examination must be in accordance with the following criteria: TBIL<1.5×ULN, ALT, AST and ALP<2.5×ULN, BUN and Cr≤1×ULN or Endogenous creatinine clearance≥50ml/min (Cockcroft-Gault formula).
- Women of childbearing age must have reliable contraceptive measures, or in the group of 7 days before the pregnancy test (serum or urine), and the results were negative, and willing to during the test and the last for 8 weeks after experimental drug using appropriate methods of contraception.For men, must be agreed to at the end of the experiments and tests of giving drugs after 8 weeks using appropriate methods of contraception or has sterilization surgery.
- Subjects were willing to join in this study, signed informed consent, good adherence, cooperate with the follow-up.
Who cannot join
- Squamous cell carcinoma (including adenosquamous carcinoma), small cell lung cancer (including small cell carcinoma and non-small cell mixed lung cancer).
- Patient gene detection is EGFR sensitive mutation, or positive for ALK fusion gene.
- Symptomatic brain metastasis (a patient with brain metastases who completed treatment and had stable symptoms 21 days before enrollment can be enrolled, but need to be confirmed by brain MRI, CT or venography to have no cerebral hemorrhage symptoms).
- Imaging (CT or MRI) showed tumor lesions ranging from ≤ 5 mm to large vessels, or central tumors that invaded local large blood vessels; or showed significant pulmonary cavitary or necrotizing tumors.
- Hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg) that is still uncontrollable using a combination of two antihypertensive drugs.
- Have the following cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval ≥ 450 ms, women ≥ 470 ms); according to NYHA criteria, grade III to IV cardiac insufficiency, Or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) <50%.
Show all 22Show fewer
- Patients with a history of pulmonary interstitial disease or a patient with pulmonary interstitial disease.
- Abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), with bleeding tendency or undergoing thrombolysis or anticoagulant therapy.
- There is obvious cough blood in the 2 months before enrollment, or the daily hemoptysis amount is 2.5ml or more.
- Into the group of the first 3 months there have been significant clinical significance of bleeding symptoms or have definite bleeding tendency.
- Events of arterial/venous thrombosis occurring within 12 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism,etc.
- Known hereditary or acquired bleeding and thrombophilia (such as hemophilia patients, coagulopathy, thrombocytopenia, hypersplenism, etc.)
- Long-term unhealed wound or fracture.
- Major surgery or severe traumatic injury, fracture or ulceration within 4 weeks of enrollment.
- Factors that have a significant impact on oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction.
- Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months prior to enrollment.
- Urine routine indicates urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0 g.
- Has a history of psychiatric drugs abuse and can't quit or have a mental disorder.
- Participated in other clinical trials of anti-tumor drugs within 4 weeks prior to enrollment.
- Previous or concurrent with other unhealed malignant tumors, except for cured skin basal cell carcinoma, cervical carcinoma in situ, and superficial bladder cancer.
- Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures.
- The investigator judges other conditions that may affect the conduct of the clinical study and the determination of the results of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pemetrexed Plus Apatinib Maintenance Treatment in Patients With Non-squamous Non-small Cell Lung Cancer Patients Who Have Not Progressed After 4 Cycles of Induction Chemotherapy of Pemetrexed in Combination With Platinum-based Regimen: A Prospective, Open, One-arm Clinical Study
In order to further improve the therapeutic efficacy of advanced no-squamous non-small cell lung cancer patients, improve the life cycle, this study will take the standard after treatment pemetrexed combined other anti-angiogenesis drugs to maintain as the direction, so as to provide more over the evidence for the treatment of advanced NSCLC.
Read the detailed description
In patients with advanced non-squamous non-small cell lung cancer, patients receiving pemetrexed and platinum-based chemotherapy after 4 cycles of non-progressive evaluation were treated with pemetrexed plus apatinib. Until the disease progresses, there are intolerable side effects or the patient requests to withdraw from the study. It is planned to include 20 subjects.
Dosing regimen： Apatinib 500mg po qd (If there is a 3-4 degree toxic side reaction after 14 days of administration, the dose can be lowered to 250mg qd); Pemetrexed 500 mg/m2 d1×q3w; Until the patient progresses, the toxicity is intolerable, the patient withdraws his knowledge, or the investigator judges that the medication must be discontinued.
- Being tested
- Apatinib, Pemetrexed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Apatinib 500 mg Po qd
PemetrexedDrug
Pemetrexe 500 mg/m2 d1×q3w
| Study group | Role | What they receive |
|---|---|---|
| Apatinib，Pemetrexe | Experimental | Pemetrexe 500 mg/m2 d1×q3w; Apatinib 500 mg Po qd Receives: Drug: Apatinib; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival（PFS）
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to three years
Measured: Up to three years
Secondary outcomes (4)
Overall survival (OS)
From date of randomization until the date of death from any cause, assessed up to three years
Measured: Up to three years
Disease control rate
Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1（RECIST1.1）.DCR includes CR, PR, SD.Complete remission (CR): All target lesions disappeared completely except for nodular disease. All target nodules must be reduced to normal size (short axis <10 mm). All target lesions must be evaluated.Partial Remission (PR): The sum of the diameters of all measurable target lesions is ≥30% below baseline. The sum of the target nodules uses a short diameter, and the sum of all other target lesions uses the longest diameter. All target lesions must be evaluated.Stable disease (SD): The extent of target lesion reduction did not reach PR, and the degree of increase did not reach PD level. Between the two, the minimum value of the sum of diameters could be used as a reference.
Measured: Up to three years
Objective response rate
ORR is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments.ORR includes CR,PR.Stable disease (SD): The extent of target lesion reduction did not reach PR, and the degree of increase did not reach PD level. Between the two, the minimum value of the sum of diameters could be used as a reference.Stable disease (SD): The extent of target lesion reduction did not reach PR, and the degree of increase did not reach PD level. Between the two, the minimum value of the sum of diameters could be used as a reference.
Measured: Up to three years
Health related quality of life
HRQoL will be evaluated based on the patient's response to the FACT-L questionnaire. The FACT-L questionnaire was validated to assess the quality of life of patients with lung cancer. The 36-item questionnaire consists of four aspects: physical status, functional status, emotional status, and social/family status. The answer consists of "none" to "very" different levels of choice. The FACT-L questionnaire has a total score of 0 to 136 points. Higher scores indicate poor patient quality of life.
Measured: Up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study startFeb 2019 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2022 (estimated)
Why it stopped: abandon
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non-squamous 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianguo Sun, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792503
- Sponsor's protocol ID
- XQonc-011
- Status last verified
- Feb 2024
- First submitted
- 2 Jan 2019
- Last updated
- 28 Feb 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pemetrexed Plus Apatinib Maintenance Treatment in Patients With Non-squamous Non-small Cell Lung Cancer Patients Who Have Not Progressed After 4 Cycles of Induction Chemotherapy of Pemetrexed in Combination With Platinum-based Regimen: A Prospective, Open, One-arm Clinical Study
- ClinicalTrials.gov ID
- NCT03792503
- Acronym / sponsor ID
- XQonc-011
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: abandon
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Study start
- Feb 2019 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 3 Jan 2019 (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.
In order to further improve the therapeutic efficacy of advanced no-squamous non-small cell lung cancer patients, improve the life cycle, this study will take the standard after treatment pemetrexed combined other anti-angiogenesis drugs to maintain as the direction, so as to provide more over the evidence for the treatment of advanced NSCLC.
Detailed description
In patients with advanced non-squamous non-small cell lung cancer, patients receiving pemetrexed and platinum-based chemotherapy after 4 cycles of non-progressive evaluation were treated with pemetrexed plus apatinib. Until the disease progresses, there are intolerable side effects or the patient requests to withdraw from the study. It is planned to include 20 subjects.
Dosing regimen： Apatinib 500mg po qd (If there is a 3-4 degree toxic side reaction after 14 days of administration, the dose can be lowered to 250mg qd); Pemetrexed 500 mg/m2 d1×q3w; Until the patient progresses, the toxicity is intolerable, the patient withdraws his knowledge, or the investigator judges that the medication must be discontinued.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib，Pemetrexe | Experimental | Drug: Apatinib, Drug: PemetrexedPemetrexe 500 mg/m2 d1×q3w; Apatinib 500 mg Po qd |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Stage IV non-squamous non-small cell lung cancer diagnosed by pathology.
- At least one measurable lesion.
- If the genetic test (EGFR/ALK) is an EGFR-sensitive mutation or an ALK fusion gene-positive patient, it is necessary to receive targeted therapy for the first-line treatment; if there is no mutation, it is necessary to be a first-line patient.
- Pemetrexed combined platinum induction chemotherapy after 4 cycles of RECIST curative effect evaluation of patients who were not progress.
- Gender is not limited, age: ≥ 18 years old.
Key exclusion criteria (22 listed)
- Squamous cell carcinoma (including adenosquamous carcinoma), small cell lung cancer (including small cell carcinoma and non-small cell mixed lung cancer).
- Patient gene detection is EGFR sensitive mutation, or positive for ALK fusion gene.
- Symptomatic brain metastasis (a patient with brain metastases who completed treatment and had stable symptoms 21 days before enrollment can be enrolled, but need to be confirmed by brain MRI, CT or venography to have no cerebral hemorrhage symptoms).
- Imaging (CT or MRI) showed tumor lesions ranging from ≤ 5 mm to large vessels, or central tumors that invaded local large blood vessels; or showed significant pulmonary cavitary or necrotizing tumors.
- Hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg) that is still uncontrollable using a combination of two antihypertensive drugs.
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 |
|---|---|---|
| ApatinibApatinib 500 mg Po qd | Drug | Apatinib，Pemetrexe |
| PemetrexedPemetrexe 500 mg/m2 d1×q3w | Drug | Apatinib，Pemetrexe |
Primary outcome
Progression free survival（PFS）
Time frame: Up to three years
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to three years
4 secondary outcomes
Overall survival (OS)
Time frame: Up to three years
Disease control rate
Time frame: Up to three years
Objective response rate
Time frame: Up to three years
Health related quality of life
Time frame: Up to three years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
Related trials for Advanced Non-squamous Non-small-cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Not yet recruitingPhase 2
Phase II Study to Evaluate Telisotuzumab Adizutecan in Combination With RC148(ABBV-1480) as First-Line Treatment for Patients With Non-Squamous Non-Small-Cell Lung Cancer
Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or Cytology
Active, not recruitingPhase 2
Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
Non-small Cell Lung Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
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 4 study testing Apatinib and Pemetrexed in people with Advanced Non-squamous Non-small-cell Lung Cancer, run by Xinqiao Hospital of Chongqing 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 22 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: withdrawn, as of the sponsor's last update on 28 Feb 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Progression free survival（PFS） (time frame: Up to three 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 28 Feb 2024.