EGFR Tyrosine Kinase Inhibitors Plus VEGFR InhibitorsPhase 3NCT02824458

A Study of Gefitinib With or Without Apatinib in Patients With Advanced Non-squamous Non-Small-Cell Lung Cancer Harboring EGFR Mutations

A Phase 3 study testing Apatinib and Gefitinib in people with EGFR Tyrosine Kinase Inhibitors Plus VEGFR Inhibitors, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: EGFR Tyrosine Kinase Inhibitors Plus VEGFR Inhibitors
What is being tested?: Apatinib and Gefitinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 246 participants
Where: 1 siteChina
Study dates: Jun 2016to Dec 2023
Phase: Phase 3
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

≥ 18 and ≤ 70 years of age
Eastern Cooperative Oncology Group(ECOG)performance scale 0 - 1.
Life expectancy of more than 3 weeks.
Histologically or cytologic confirmed，locally advanced and/or metastatic non-squamous NSCLC of stage IIIB (unsuitable for radiotherapy) or IV or recurrent NSCLC; At least one measurable lesion according to RECIST 1.1 which has not received radiotherapy or cryotherapy.
Documented evidence of tumor harboring an activating EGFR mutation (Example 19 del and L858R) .
None previous chemotherapy or targeted therapy. NOTE: neoadjuvant and/or adjuvant therapy is allowed which is completed before 6 months.

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Prior radiation therapy is allowed if: 25% or less of total bone marrow had been irradiated,pelvis and chest had not been irradiated; at least 4 weeks have elapsed from the completion of radiation treatment, and the acute toxicity from radiation treatment had been recover; irradiated lesion is not including measurable lesions unless documented progress after radiation.
Adequate hepatic, renal, heart, and hematologic functions (Absolute Neutrophil Count(ANC) ≥ 1.5×109/L, Platelet (PLT) ≥ 100×109/L, Hemoglobin(HB) ≥ 100 g/L, total bilirubin within 1.5×the upper limit of normal(ULN), and serum transaminase≤2.5×the Upper Limit Of Normal(ULN), serum creatine ≤ 1 x Upper Limit Of Normal(ULN), creatinine clearance rate ≥ 50ml/min,
For women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug.
Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Who cannot join

Squamous cell carcinoma (including adenosquamous carcinoma, undifferentiated carcinoma); small cell lung cancer (including small cell and non-small cell mixed lung cancer)
Symptomatic brain metastases (Patients who have no symptoms and is not needed to receive therapy before 21 days may participate in this trial, but need to be confirmed by MRI\CT or venography that no hematencephalon symptom);
Radiologically documented evidence of major blood vessel invasion or encasement by cancer; Obvious cavity or necrosis formed in the tumor.
Uncontrolled hypertension(systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) even though two or more than two hypotensive agents application.
Patients who suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association(NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)<50%;
History of pulmonary interstitial diseases or concurrent pulmonary interstitial diseases.

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Coagulation disfunction（INR>1.5 o rPT>Upper Limit Of Normal(ULN)+4s or Activated Partial Thromboplastin Time (APTT) >1.5 Upper Limit Of Normal(ULN)）, hemorrhagic tendency or receiving the therapy of thrombolysis or anticoagulation.
History of clinically significant haemoptysis =< 2 months (more than 2.5ml or half of one tea spoon of fresh blood per day) prior to registration.
History of clinically relevant major bleeding event (e.g. gastrointestinal hemorrhage, bleeding gastric ulcer, occult blood test ≥ (++), and vasculitis ;
Within 6 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack(TIA), hematencephalon, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.
Known inherited and acquired hemorrhagic and thromboplastic possibility (such as hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc.)
Long-term untreated wounds or fractures.
Within 4 weeks of major surgery and/or injures, fractures , ulceration.
Significant factors that influence the ingestion and absorption of medicine, (e.g. unable swallow, chronic diarrhea and intestinal obstruction);
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess ≤ 6 months.
Urine protein≥++, or 24h urine protein quantitation≥1.0g;
Symptomatic serous effusion requiring treatment .(including hydrothorax, ascites, hydropericardium);
Active infection need antimicrobial treatments;
History of psychiatric drugs abuse and not be abstinent, or dysphrenia;
Less than 4 weeks from the last clinical trial
History or concomitant other malignancy except cured basal cell skin cancer, or carcinoma in situ of the cervix, or superficial bladder cancer;
Administration of strong/potent cytochrome P450 (CYP)3A4 inhibitors within 7 days, or inducers within 12 days;
Pregnant or breastfeeding women;
Other conditions regimented at investigators' discretion.

Trial locations and contacts

1 site in 1 country.

Hongyun Zhao contact

86-20-8734 2482

zhaohy@sysucc.org.cn

China1 site, 1 recruiting

Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Hongyun Zhao, PhD, 86-20-8734 2482, zhaohy@sysucc.org.cn
Recruiting

Other trials in China

About this study

Official title: A Multicenter, Randomized,Double-Blind Study of Gefitinib in Combination With Apatinib or Placebo in Previously Untreated Patients With EGFR Mutation-Positive Advanced Non-squamous Non-Small-Cell Lung Cancer

The main purpose of this study is to evaluate the safety and efficacy of Apatinib in combination with Gefitinib as compared to placebo in combination with Gefitinib in participants with stage ⅢB-IV Non-squamous non-small-cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Del19 and L858R). Safety and tolerability of Apatinib in combination with Gefitinib will be assessed in the first portion (Part A) before proceeding to the second portion of this study (Part B).

Conditions: EGFR Tyrosine Kinase Inhibitors Plus VEGFR Inhibitors
Being tested: Apatinib, Gefitinib, Placebo
Keywords: EGFR tyrosine kinase inhibitors, VEGFR inhibitor, NSCLC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ApatinibDrug
Also called YN968D1
Patients will be treated with Apatinib, 250/500/750 mg(dose determined from Part A of study) p.o., daily
GefitinibDrug
Also called Iressa
Patients will be treated with Gefitinib, 250 mg p.o., daily
PlaceboDrug

Study groups in NCT02824458
Study group	Role	What they receive
Gefitinib + Apatinib	Experimental	(Part A) Phase I, Open-label, Dose-escalation Study Escalating doses(500mg, 750mg, or 250mg) of Apatinib in combination with 250mg Gefitinib daily orally. Participants may continue to receive treatment until progress or intolerable. (Part B)Multicenter, Randomized, Double-Blind Study Apatinib (dose determined from Part A of study) in combination with 250mg Gefitinib. Receives: Drug: Apatinib; Drug: Gefitinib
Gefitinib + Placebo	Placebo comparator	(Part A) Not Applicable (Part B) Placebo in combination with 250mg Gefitinib. Participants may continue to receive treatment until progress or intolerable. Receives: Drug: Gefitinib; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

(Part A) Determine Dose-Limiting Toxicity (DLT) of Apatinib in combination with Gefitinib
Determine the safety, tolerability and DLTs of Apatinib in Combination With Gefitinib
Measured: 1 months
(Part A) Maximum Tolerated Dose (MTD) of Apatinib in Combination With Gefitinib
MTD was determined by testing increasing doses up to 750 mg daily (qd) on dose escalation cohorts 1 to 3 with 3 patients each. MTD reflects highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity (DLT) in more than 30% of patients; e.g., hematologic toxicities like Common Toxicity Criteria (CTC) Grade 4 Neutropenia in specific conditions, platelets < 25,000 cells/mL; specific non-hematologic/biochemical toxicities CTC Grade 3 or 4; additionally, any toxicity considered by the investigator severe enough was designated a DLT); CTC Version 2 were used.
Measured: 1 months
(Part B) Progression Free Survival (PFS)
Time from the date of enrolment until documented progression or death, whichever occurs first.
Measured: Randomization to Measured Progressive Disease or Death from Any Cause (Estimated as 42 Months)

Secondary outcomes (17)

(Part B) Overall Survival (OS)
Time from the date of enrolment until death from any cause.
Measured: Randomization to Date of Death from Any Cause (Estimated as 50 Months)
(Part B) Objective Response Rate (ORR)
Best overall response (complete remission or partial remission) across all assessment time-points according to RECIST Criteria 1.1, during the period from enrolment to termination of trial treatment
Measured: Randomization to Disease Progression (Estimated as 42 Months)
(Part B) Disease Control Rate (DCR)
Achievement of objective response or stable disease for at least 6 weeks
Measured: Randomization to Disease Progression (Estimated as 42 Months)
(Part B) Duration of Response (DoR)
Interval from the date of first documentation of objective response by RECIST to the date of first documented progression or relapse
Measured: Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Estimated as 42 Months)
(Part B) Time to progression disease (TTPD)
Time to progression disease
Measured: Randomization to Measured Progressive Disease (Estimated as 42 Months)
(Part B) Quality of Life (QoL) questionnaire
Measured: Baseline, End of Study (Estimated as 50 Months)
(Part A + B) Safety assessment : Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
including adverse events, physical examination, vital signs (including Blood Pressure(BP)), clinical chemistry and hematology
Measured: Randomization to Measured Progressive Disease (Estimated as 50 Months)
(Part A) Area Under roc Curve (last)
Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration
Measured: Apatinib & Gefitinib: Cycle1 Day 1 and 15
(Part A) Area Under roc Curve (tau)
Area under the plasma concentration time profile after single dose from time zero to the next dose
Measured: Apatinib & Gefitinib: Cycle1 Day 1 and 15
(Part A) Cmax
Maximum observed plasma concentration
Measured: Apatinib & Gefitinib: Cycle1 Day 1 and 15
(Part A) Tmax
Time for Cmax
Measured: Apatinib & Gefitinib: Cycle1 Day 1 and 15
(Part A) t½a
Terminal half life
Measured: Apatinib & Gefitinib: Cycle1 Day 1 and 15
(Part A) Ctrough
Predose concentration during multiple dosing
Measured: Apatinib & Gefitinib: Cycle1 Day 1 and 15
(Part A) The Apparent Clearance(CL/F)
Apparent clearance
Measured: Apatinib & Gefitinib: Cycle1 Day 1 and 15
(Part A) The Apparent Volume of Distribution (Vd/F)
Apparent volume of distribution
Measured: Apatinib & Gefitinib: Cycle1 Day 1 and 15
(Part A) The Metabolite to Parent Ratio of Area Under roc Curve (tau)
Metabolite to parent ratio for Area Under roc Curve (tau)
Measured: Apatinib & Gefitinib: Cycle1 Day 1 and 15
(Part A) The Metabolite to Parent Ratio of Css,max(MRCmax)
Metabolite to parent ratio for Cmax
Measured: Apatinib & Gefitinib: Cycle1 Day 1 and 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2016Dec 2023

First posted6 Jul 2016 (estimated)
Study startJun 2016
Primary completionDec 2023 (estimated)
Study completionDec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for EGFR Tyrosine Kinase Inhibitors Plus VEGFR InhibitorsStudies of the same condition, open and under way.
More trials run by Sun Yat-sen 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 246 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02824458
Sponsor's protocol ID: 2016-FXY-023
Status last verified: Jul 2016
First submitted: 23 Jun 2016
Last updated: 7 Jul 2016
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

Zhao H, Yao W, Min X, Gu K, Yu G, Zhang Z, Cui J, Miao L, Zhang L, Yuan X, Fang Y, Fu X, Hu C, Zhu X, Fan Y, Yu Q, Wu G, Jiang O, Du X, Liu J, Gu W, Hou Z, Wang Q, Zheng R, Zhou X, Zhang L. Apatinib Plus Gefitinib as First-Line Treatment in Advanced EGFR-Mutant NSCLC: The Phase III ACTIVE Study (CTONG1706). J Thorac Oncol. 2021 Sep;16(9):1533-1546. doi: 10.1016/j.jtho.2021.05.006. Epub 2021 May 24.
PubMed 34033974
Deng Z, Qin Y, Liu Y, Zhang Y, Lu Y. Role of Antiangiogenic Agents Combined With EGFR Tyrosine Kinase Inhibitors in Treatment-naive Lung Cancer: A Meta-Analysis. Clin Lung Cancer. 2021 Jan;22(1):e70-e83. doi: 10.1016/j.cllc.2020.08.005. Epub 2020 Sep 18.
PubMed 33067126
Zhang Z, Zhang Y, Luo F, Ma Y, Fang W, Zhan J, Li S, Yang Y, Zhao Y, Hong S, Zhou T, Zhang Y, Zhao S, Huang Y, Zhao H, Zhang L. Dual blockade of EGFR and VEGFR pathways: Results from a pilot study evaluating apatinib plus gefitinib as a first-line treatment for advanced EGFR-mutant non-small cell lung cancer. Clin Transl Med. 2020 Jun;10(2):e33. doi: 10.1002/ctm2.33. Epub 2020 Jun 4.
PubMed 32508029
Zhang Z, Luo F, Zhang Y, Ma Y, Hong S, Yang Y, Fang W, Huang Y, Zhang L, Zhao H. The ACTIVE study protocol: apatinib or placebo plus gefitinib as first-line treatment for patients with EGFR-mutant advanced non-small cell lung cancer (CTONG1706). Cancer Commun (Lond). 2019 Nov 7;39(1):69. doi: 10.1186/s40880-019-0414-4.
PubMed 31699150

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized,Double-Blind Study of Gefitinib in Combination With Apatinib or Placebo in Previously Untreated Patients With EGFR Mutation-Positive Advanced Non-squamous Non-Small-Cell Lung Cancer
ClinicalTrials.gov ID: NCT02824458
Acronym / sponsor ID: 2016-FXY-023
Conditions: EGFR Tyrosine Kinase Inhibitors Plus VEGFR Inhibitors
Keywords: EGFR tyrosine kinase inhibitors, VEGFR inhibitor, NSCLC
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 246 participants (estimated)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Study start: Jun 2016
Primary completion: Dec 2023 (estimated)
Study completion: Dec 2023 (estimated)
First posted: 6 Jul 2016 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Gefitinib + Apatinib	Experimental	Drug: Apatinib, Drug: Gefitinib(Part A) Phase I, Open-label, Dose-escalation Study Escalating doses(500mg, 750mg, or 250mg) of Apatinib in combination with 250mg Gefitinib daily orally. Participants may continue to receive treatment until progress or intolerable. (Part B)Multicenter, Randomized, Double-Blind Study Apatinib (dose determined from Part A of study) in combination with 250mg Gefitinib.
Gefitinib + Placebo	Placebo comparator	Drug: Gefitinib, Drug: Placebo(Part A) Not Applicable (Part B) Placebo in combination with 250mg Gefitinib. Participants may continue to receive treatment until progress or intolerable.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

≥ 18 and ≤ 70 years of age
Eastern Cooperative Oncology Group(ECOG)performance scale 0 - 1.
Life expectancy of more than 3 weeks.
Histologically or cytologic confirmed，locally advanced and/or metastatic non-squamous NSCLC of stage IIIB (unsuitable for radiotherapy) or IV or recurrent NSCLC; At least one measurable lesion according to RECIST 1.1 which has not received radiotherapy or cryotherapy.
Documented evidence of tumor harboring an activating EGFR mutation (Example 19 del and L858R) .

Key exclusion criteria (24 listed)

Squamous cell carcinoma (including adenosquamous carcinoma, undifferentiated carcinoma); small cell lung cancer (including small cell and non-small cell mixed lung cancer)
Symptomatic brain metastases (Patients who have no symptoms and is not needed to receive therapy before 21 days may participate in this trial, but need to be confirmed by MRI\CT or venography that no hematencephalon symptom);
Radiologically documented evidence of major blood vessel invasion or encasement by cancer; Obvious cavity or necrosis formed in the tumor.
Uncontrolled hypertension(systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) even though two or more than two hypotensive agents application.
Patients who suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association(NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)<50%;

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: YN968D1Patients will be treated with Apatinib, 250/500/750 mg(dose determined from Part A of study) p.o., daily	Drug	Gefitinib + Apatinib
GefitinibAlso: IressaPatients will be treated with Gefitinib, 250 mg p.o., daily	Drug	Gefitinib + Apatinib, Gefitinib + Placebo
Placebo	Drug	Gefitinib + Placebo

Primary outcome

(Part A) Determine Dose-Limiting Toxicity (DLT) of Apatinib in combination with Gefitinib
Time frame: 1 months
Determine the safety, tolerability and DLTs of Apatinib in Combination With Gefitinib
(Part A) Maximum Tolerated Dose (MTD) of Apatinib in Combination With Gefitinib
Time frame: 1 months
MTD was determined by testing increasing doses up to 750 mg daily (qd) on dose escalation cohorts 1 to 3 with 3 patients each. MTD reflects highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity (DLT) in more than 30% of patients; e.g., hematologic toxicities like Common Toxicity Criteria (CTC) Grade 4 Neutropenia in specific conditions, platelets < 25,000 cells/mL; specific non-hematologic/biochemical toxicities CTC Grade 3 or 4; additionally, any toxicity considered by the investigator severe enough was designated a DLT); CTC Version 2 were used.
(Part B) Progression Free Survival (PFS)
Time frame: Randomization to Measured Progressive Disease or Death from Any Cause (Estimated as 42 Months)
Time from the date of enrolment until documented progression or death, whichever occurs first.

17 secondary outcomes

(Part B) Overall Survival (OS)
Time frame: Randomization to Date of Death from Any Cause (Estimated as 50 Months)
(Part B) Objective Response Rate (ORR)
Time frame: Randomization to Disease Progression (Estimated as 42 Months)
(Part B) Disease Control Rate (DCR)
Time frame: Randomization to Disease Progression (Estimated as 42 Months)
(Part B) Duration of Response (DoR)
Time frame: Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Estimated as 42 Months)
(Part B) Time to progression disease (TTPD)
Time frame: Randomization to Measured Progressive Disease (Estimated as 42 Months)
(Part B) Quality of Life (QoL) questionnaire
Time frame: Baseline, End of Study (Estimated as 50 Months)
(Part A + B) Safety assessment : Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Randomization to Measured Progressive Disease (Estimated as 50 Months)
(Part A) Area Under roc Curve (last)
Time frame: Apatinib & Gefitinib: Cycle1 Day 1 and 15
(Part A) Area Under roc Curve (tau)
Time frame: Apatinib & Gefitinib: Cycle1 Day 1 and 15
(Part A) Cmax
Time frame: Apatinib & Gefitinib: Cycle1 Day 1 and 15
(Part A) Tmax
Time frame: Apatinib & Gefitinib: Cycle1 Day 1 and 15
(Part A) t½a
Time frame: Apatinib & Gefitinib: Cycle1 Day 1 and 15
(Part A) Ctrough
Time frame: Apatinib & Gefitinib: Cycle1 Day 1 and 15
(Part A) The Apparent Clearance(CL/F)
Time frame: Apatinib & Gefitinib: Cycle1 Day 1 and 15
(Part A) The Apparent Volume of Distribution (Vd/F)
Time frame: Apatinib & Gefitinib: Cycle1 Day 1 and 15
(Part A) The Metabolite to Parent Ratio of Area Under roc Curve (tau)
Time frame: Apatinib & Gefitinib: Cycle1 Day 1 and 15
(Part A) The Metabolite to Parent Ratio of Css,max(MRCmax)
Time frame: Apatinib & Gefitinib: Cycle1 Day 1 and 15

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
Derived from this study: PubMed 34033974Zhao H, Yao W, Min X, Gu K, Yu G, Zhang Z, Cui J, Miao L, Zhang L, Yuan X, Fang Y, Fu X, Hu C, Zhu X, Fan Y, Yu Q, Wu G, Jiang O, Du X, Liu J, Gu W, Hou Z, Wang Q, Zheng R, Zhou X, Zhang L. Apatinib Plus Gefitinib as First-Line Treatment in Advanced EGFR-Mutant NSCLC: The Phase III ACTIVE Study (CTONG1706). J Thorac Oncol. 2021 Sep;16(9):1533-1546. doi: 10.1016/j.jtho.2021.05.006. Epub 2021 May 24.
Derived from this study: PubMed 33067126Deng Z, Qin Y, Liu Y, Zhang Y, Lu Y. Role of Antiangiogenic Agents Combined With EGFR Tyrosine Kinase Inhibitors in Treatment-naive Lung Cancer: A Meta-Analysis. Clin Lung Cancer. 2021 Jan;22(1):e70-e83. doi: 10.1016/j.cllc.2020.08.005. Epub 2020 Sep 18.
Derived from this study: PubMed 32508029Zhang Z, Zhang Y, Luo F, Ma Y, Fang W, Zhan J, Li S, Yang Y, Zhao Y, Hong S, Zhou T, Zhang Y, Zhao S, Huang Y, Zhao H, Zhang L. Dual blockade of EGFR and VEGFR pathways: Results from a pilot study evaluating apatinib plus gefitinib as a first-line treatment for advanced EGFR-mutant non-small cell lung cancer. Clin Transl Med. 2020 Jun;10(2):e33. doi: 10.1002/ctm2.33. Epub 2020 Jun 4.
Derived from this study: PubMed 31699150Zhang Z, Luo F, Zhang Y, Ma Y, Hong S, Yang Y, Fang W, Huang Y, Zhang L, Zhao H. The ACTIVE study protocol: apatinib or placebo plus gefitinib as first-line treatment for patients with EGFR-mutant advanced non-small cell lung cancer (CTONG1706). Cancer Commun (Lond). 2019 Nov 7;39(1):69. doi: 10.1186/s40880-019-0414-4.
Individual participant dataSharing planned: Undecided

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.

Hongyun Zhao contact

86-20-8734 2482

zhaohy@sysucc.org.cn

Hongyun Zhao principal investigator

Sun Yat-Sen University Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apatinib and Gefitinib in people with EGFR Tyrosine Kinase Inhibitors Plus VEGFR Inhibitors, run by Sun Yat-sen 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 24 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 7 Jul 2016. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Hongyun Zhao (86-20-8734 2482, zhaohy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

(Part A) Determine Dose-Limiting Toxicity (DLT) of Apatinib in combination with Gefitinib (time frame: 1 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02824458, which also lists 4 linked publications.

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 7 Jul 2016.