Lung DiseasesPhase 2NCT03389256
Apatinib in the Treatment of Patients With EGFR T790M-Negative NSCLC
A Phase 2 study testing Apatinib and EGFR-TKI in people with Lung Diseases and Neoplasms, run by Sichuan Cancer Hospital and Research Institute at 3 sites in China.
Trial summary
This phase 2 study is designed to evaluate the safety and activity of apatinib,a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2, in combination with EGFR-TKI in NSCLC with T790M-negative after the failure of EGFR-TKI therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Diseases, Neoplasms, Respiratory Tract Diseases
- What is being tested?
- Apatinib and EGFR-TKI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 3 sitesChina
- Study dates
- 30 Dec 2018to 30 Aug 2022
- 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
- Pathologically confirmed stage IIIB, IV non-squamous non-small cell lung cancer, with measurable lesions (the long axis of tumor lesions ≥ 10mm with CT, the short axis of lymph node lesions ≥ 15mm with CT, the lesions not receive radiotherapy, frozen or other local treatment);
- Patients with slow progression on first-line EGFR TKI(erlotinib / icotinib / gefitinib) treatment;
- No T790M mutation including an assessment from tumor biopsy obtained while on or subsequent to the most recent EGFR TKI therapy;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- Life expectancy of more than 3 months;
- Adequate bone marrow function: WBC ≥ 3.0 ×10 E+9/L, neutrophil ≥ 1.5 × 10 E+9/L, platelets ≥ 80 × 10E+9/L,Hb ≥ 10.0g/dL;a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL), a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤3UNL or ≤5UNL in case of liver metastasis, a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault);
- Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 8 weeks after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug;
- the participants volunteered to join this study should sign the informed consent forms, have better compliance in the follow-up;
Who cannot join
- Squamous cell carcinoma (including adenosquamous carcinoma); Small cell lung carcinoma (including small cell carcinoma and non-small cell mixed lung carcinoma);
- Active brain metastases, cancerous meningitis, patients with spinal cord compression;
- Rapid progression of the disease or cancer invades vital organs;
- The distance between the tumor lesion and the large blood vessel is less than 5 mm, or there is a central tumor invading local macrovascular;
- obvious pulmonary cavity or tumor necrosis;
- Uncontrollable high blood pressure;
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- Grade Ⅱ or above myocardial ischemia or myocardial infarction or arrhythmia control is not good,Ⅲ ~ Ⅳ grade cardiac insufficiency, or cardiac ultrasonography showed left ventricular ejection fraction (LVEF) <50% according to the NYHA standard;
- Have a history of interstitial lung disease or patients with interstitial lung disease;
- Coagulation abnormalities (INR> 1.5 or PT> ULN + 4s or APTT> 1.5 ULN) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
- There was significant hemoptysis within 2 months prior to enrollment, or a daily hemoptysis volume is 2.5 ml or above;
- A clinically significant bleeding symptom or bleeding tendencies such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ and above, or vasculitis that occurred within 3 months prior to enrollment;
- Aneurysm / venous thrombotic events such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
- Arterial / venous thrombotic events such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism within 12 months prior to enrollment;
- Hereditary or acquired bleeding and thrombophilia, such as hemophilia, coagulopathy, thrombocytopenia, hypersplenism；
- Long-term unhealed wounds or fractures;
- Major surgery or severe traumatic injury, fracture or ulcer within 4 weeks prior to enrollment;
- Unable to swallow, chronic diarrhea or intestinal obstruction;
- Abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 months prior to enrollment;
- Urinary protein ≥ ++, 24-hour urinary protein ≥ 1.0 g;
- Active infections require antimicrobial treatment;
- ALK gene abnormalities (gene fusion or mutation occurred);
- Pregnant or lactating women, or women unwilling or unable to take effective contraception;
Trial locations and contacts
3 sites in 1 country.
China3 sites
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Panwen Tian, MD, +8618036675920
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610071
Rui Ao, MD, +8618036675290, aorui1040@hotmail.com
About this study
Official title: A Randomized, Controlled Phase II Clinical Trial of Apatinib in Combination With EGFR-TKI Versus EGFR-TKI for Non-squamous, Non-small Cell Lung Cancer(NSCLC) With T790M-negative After the Failure of EGFR-TKI Therapy
This phase 2 study is designed to evaluate the safety and activity of apatinib,a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2, in combination with EGFR-TKI in NSCLC with T790M-negative after the failure of EGFR-TKI therapy.
- Conditions
- Lung Diseases, Neoplasms, Respiratory Tract Diseases, Thoracic Neoplasms, Non-Small-Cell Lung
- Being tested
- Apatinib, EGFR-TKI
- Keywords
- apatinib, T790 negative, NSCLC
- Medical subject headings
- Lung Diseases, Neoplasms, Respiratory Tract Diseases, Thoracic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Also called apatinib tablets
Apatinib mesylate tablets 250 mg qd po, if the patient can tolerate the toxic side effects, adjust the dose to 500mg qd po after 1 week.
EGFR-TKIDrug
Also called Imatinib、Gefitinib or Erlotinib
Imatinib tablets, 125 mg tid po; gefitinib tablets, 250 mg qd po; erlotinib tablets, 150 mg qd po
| Study group | Role | What they receive |
|---|---|---|
| apatinib combine with EGFR-TKI | Experimental | Every 4 weeks 1 cycle, evaluated the efficacy and safety once every 2 cycles, treat until disease progression or intolerable toxicity Receives: Drug: Apatinib; Drug: EGFR-TKI |
| EGFR-TKI | Active comparator | Every 4 weeks 1 cycle, evaluated the efficacy and safety once every 2 cycles, treat until disease progression or intolerable toxicity Receives: Drug: EGFR-TKI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse
Measured: up to 24 months
Secondary outcomes (5)
Overall survival (OS)
The length of time from either the date of diagnosis or the start of treatment that half of the patients in a group of patients diagnosed with the disease are still alive.
Measured: up to 36 months
Duration of response (DOR)
From first response to the date of first documented disease progression
Measured: up to 24 months
Disease Control Rate (DCR)
the proportion of patients with a best overall response of CR, PR or SD in the whole body, as assessed per RECIST 1.1 by the investigator.
Measured: 24 weeks
Overall response rate (ORR)
the proportion of patients with a best overall confirmed response of CR or PR in the whole body as assessed per RECIST 1.1 by the investigator
Measured: 24 weeks
the quality of life (QoL)
Analysis of changes from baseline using the quality of life (QoL) instrument
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start30 Dec 2018 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Juan LI, MD, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389256
- Sponsor's protocol ID
- APTN-NSCLC-201712
- Status last verified
- Dec 2017
- First submitted
- 26 Dec 2017
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Phase II Clinical Trial of Apatinib in Combination With EGFR-TKI Versus EGFR-TKI for Non-squamous, Non-small Cell Lung Cancer(NSCLC) With T790M-negative After the Failure of EGFR-TKI Therapy
- ClinicalTrials.gov ID
- NCT03389256
- Acronym / sponsor ID
- APTN-NSCLC-201712
- Conditions
- Lung Diseases, Neoplasms, Respiratory Tract Diseases, Thoracic Neoplasms, Non-Small-Cell Lung
- Keywords
- apatinib, T790 negative, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 30 Dec 2018 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 3 Jan 2018 (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 phase 2 study is designed to evaluate the safety and activity of apatinib,a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2, in combination with EGFR-TKI in NSCLC with T790M-negative after the failure of EGFR-TKI therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| apatinib combine with EGFR-TKI | Experimental | Drug: Apatinib, Drug: EGFR-TKIEvery 4 weeks 1 cycle, evaluated the efficacy and safety once every 2 cycles, treat until disease progression or intolerable toxicity |
| EGFR-TKI | Active comparator | Drug: EGFR-TKIEvery 4 weeks 1 cycle, evaluated the efficacy and safety once every 2 cycles, treat until disease progression or intolerable toxicity |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pathologically confirmed stage IIIB, IV non-squamous non-small cell lung cancer, with measurable lesions (the long axis of tumor lesions ≥ 10mm with CT, the short axis of lymph node lesions ≥ 15mm with CT, the lesions not receive radiotherapy, frozen or other local treatment);
- Patients with slow progression on first-line EGFR TKI(erlotinib / icotinib / gefitinib) treatment;
- No T790M mutation including an assessment from tumor biopsy obtained while on or subsequent to the most recent EGFR TKI therapy;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- Life expectancy of more than 3 months;
Key exclusion criteria (22 listed)
- Squamous cell carcinoma (including adenosquamous carcinoma); Small cell lung carcinoma (including small cell carcinoma and non-small cell mixed lung carcinoma);
- Active brain metastases, cancerous meningitis, patients with spinal cord compression;
- Rapid progression of the disease or cancer invades vital organs;
- The distance between the tumor lesion and the large blood vessel is less than 5 mm, or there is a central tumor invading local macrovascular;
- obvious pulmonary cavity or tumor necrosis;
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 |
|---|---|---|
| ApatinibAlso: apatinib tabletsApatinib mesylate tablets 250 mg qd po, if the patient can tolerate the toxic side effects, adjust the dose to 500mg qd po after 1 week. | Drug | apatinib combine with EGFR-TKI |
| EGFR-TKIAlso: Imatinib、Gefitinib or ErlotinibImatinib tablets, 125 mg tid po; gefitinib tablets, 250 mg qd po; erlotinib tablets, 150 mg qd po | Drug | EGFR-TKI, apatinib combine with EGFR-TKI |
Primary outcome
Progression-free survival (PFS)
Time frame: up to 24 months
the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse
5 secondary outcomes
Overall survival (OS)
Time frame: up to 36 months
Duration of response (DOR)
Time frame: up to 24 months
Disease Control Rate (DCR)
Time frame: 24 weeks
Overall response rate (ORR)
Time frame: 24 weeks
the quality of life (QoL)
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib and EGFR-TKI in people with Lung Diseases and Neoplasms, run by Sichuan Cancer Hospital and Research Institute at 3 sites 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 8 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: status not confirmed, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Juan Li, MD (+8613880276636, dr.lijuan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: up to 24 months). 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 3 Jan 2018.