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Lung CancerPhase 1/2NCT03201146

Apatinib Combine With Platinum-Based Doublet Chemotherapy for First-line Treatment of Advanced NSCLC

A Phase 1/2 study testing Apatinib, AP or AC and Apatinib 250mg in people with Lung Cancer and Non Small Cell Lung Cancer, run by West China Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

The purpose of this study is to evaluate the safety and clinical activity of Apatinib in combination with AP(Pemetrexed/Carboplatin) or AC(Pemetrexed/Carboplatin) as first-line chemotherapy in subjects with advanced EGFR wild type non-squamous non-small cell lung cancer(NSCLC). Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Apatinib, AP or AC and Apatinib 250mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
27 Jun 2017to 1 Aug 2020
Phase
Phase 1/2
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

  • 1. Signed the informed consent form prior to patient entry.
  • 2. ≥ 18 and ≤ 70 years of age.
  • 3. Histologically or pathologically confirmed non-squamous EGFR wild-type, ALK-rearrangement negative, stage IV non-small cell lung cancer(NSCLC).
  • 4. Must have at least one measurable lesion as per RECIST 1.1 defined as a lesion that is 10mm in longest diameter or lymph node that is 15mm in short axis imaged by CT scan, prior topical treatment, such as radiotherapy or cryosurgery to the lesions is not allowed.
  • 5. No prior systemic chemotherapy for advanced or metastatic NSCLC.
  • 6. Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
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  • 7. Life expectancy of more than 3 months.
  • 8. 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.
  • 9. Adequate hepatic and renal functions: a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL), a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis, a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault).
  • 10. With normal coagulation function: INR and PTT, each ≤ 1.5 x ULN.
  • 11. Adequate cardiovascular function: left ventricular ejection fraction (LVEF) ≥ 50%, QTcF ≤ 450 msec.
  • 12. Alkaline phosphatase ≤ 2.5 x ULN.
  • 13. The subjects are willing to coordinate with the follow-up with good compliance.
  • 14. 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.

Who cannot join

  • 1. Patients with active brain metastasis, carcinomatous meningitis, or spinal compression, or disease of brain or pia mater according to the screening test, imaging, CT or MRI tests (patients who have completed the treatment and in a stable condition 21 days before screening could be included, but brain MRI, CT or venography is required to confirm that there are no brain hemorrhage symptoms).
  • 2. Patients with uncontrollable hypertension (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg, despite optimal drug therapy).
  • 3. Patients with with grade Ⅱ myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male ≥ 450 ms, female ≥470 ms).
  • 4. According to NYHA standard, grade Ⅲ ~ Ⅳ heart failure, or cardiac color Doppler ultrasound examination showed left ventricular ejection fraction (LVEF) <50%.
  • 5. Coagulation dysfunction (INR> 1.5, PT> ULN +4s or APTT> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment.
  • 6. Patients treated with anticoagulation agents or Vitamin K antagonist such as Warfarin, heparin, or other similar drugs.
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  • 7. Patients who had obvious hemoptysis within 2 months before screening, or experienced daily hemoptysis with a volume more than half a tea spoon (2.5ml) or above.
  • 8. Patients who experienced bleeding symptoms of clinical significance within 3 months before screening, or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc.
  • 9. Patients who manifested arterial/venous thrombus events, e.g. cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening.
  • 10. Known genetic or acquired bleeding or bleeding tendency (such as hemophilia, blood coagulation dysfunction, thrombocytopenia, and hypersplenism, etc.).
  • 11. Patients who have unhealed wounds or fractures for a long time.
  • 12. Patients who received major surgical operations or experienced severe traumatic injuries, bone fracture, or ulcers within 4 weeks before screening.
  • 13. Patients with obvious factors affecting absorption of oral drugs, such as difficulties in swallowing, chronic diarrhea and intestinal obstruction, etc.
  • 14. Occurrence of abdominal fistula, gastrointestinal perforation, or intraperitoneal abscess within 6 months before screening.
  • 15. Patients whose routine urine tests indicate that urine protein ≥ ++ or verifies that the 24-h urine protein quantitation ≥ 1.0 g.
  • 16. Patients with active hepatitis B virus or hepatitis c virus infection.
  • 17. Active infection requiring antimicrobial treatment, such as antibacterial, antifungal, or antiviral therapy.
  • 18. Patients with clinical symptoms, or dropsy of serous cavity requiring surgical treatment (including hydrothorax, ascites, and hydropericardium).
  • 19. Patients who have a history of psychotropic drug abuse and are unable to break the habit, or who have a psychogeny.
  • 20. Patients who have taken part in other drug clinical tests within 4 weeks before screening.
  • 21. Prior VEGFR inhibitor treatment.
  • 22. Patients who formerly suffered from or currently are complicated with other uncured malignant tumors, except basal cell carcinoma, carcinoma in situ of cervix and superficial bladder cancer that have been cured.
  • 23. Patients who received the treatment with potent CYP3A4 inhibitors within 7 days before screening, or potent CYP3A4 inducers within 12 days before being included.
  • 24. Pregnant or lactating women, fertile patients who are unwilling or unable to take effective contraceptive measures.
  • 25. Conditions determined by investigators to possibly affect the clinical study or determination of the study results.

Trial locations and contacts

1 site in 1 country.

You Lu, MD contact

86-028-85422114

radyoulu@hotmail.com

Meijuan Huang, MD contact

86-028-85422114

hmj107@163.com

China1 site, 1 recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    You Lu, MD, 86-028-85422114, radyoulu@hotmail.com

    Meijuan Huang, MD, 86-028-85422114, hmj107@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase 1/2 Study of Apatinib in Combination With AP(Pemetrexed/Cisplatin) or AC(Pemetrexed/Carboplatin) as First-line Chemotherapy for Advanced Epidermal Growth Factor Receptor(EGFR) Wild Type Non-squamous Non-small Cell Lung Cancer

The purpose of this study is to evaluate the safety and clinical activity of Apatinib in combination with AP(Pemetrexed/Carboplatin) or AC(Pemetrexed/Carboplatin) as first-line chemotherapy in subjects with advanced EGFR wild type non-squamous non-small cell lung cancer(NSCLC).

Read the detailed description

Apatinib, an oral highly potent tyrosine-kinase inhibitor targeting VEGFR-2, has demonstrated improved survival in previously treated patients with advanced non-small-cell lung cancer(NSCLC).

The phase I study is conducted to explore the safety, tolerability, dose-limiting toxicities(DLT), Maximum Tolerable Dose(MTD), and preliminary anti-tumor activity of Apatinib combined with platinum-based doublet chemotherapy(PB-DC) in first-line advanced EGFR wild type non-squamous non-small cell lung cancer. This will use a dose reduction trial design. A cohort of 3~6 subjects will be enrolled at each dose level, If 0 of 3 or ≤ 1 of 6 subjects experience a DLT, the phase I trial will stop and the current dose will be considered the MTD. If 1 of 6 or more subjects experiences a DLT, dose reduce to the next dose will occur.

Following completion of the dose de-escalation trial and determination of MTD, A randomized controlled trial(RCT) including 30 subjects may be enrolled to further evaluate safety, tolerability, and preliminary anti-tumor activity of Apatinib in combination with platinum-based doublet chemotherapy(PB-DC) in the same target population.

Being tested
Apatinib, AP or AC, Apatinib 250mg, Apatinib 500mg, Apatinib 750mg
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • ApatinibDrug

    Also called YN968D1

    Doses to be determined following the completion of Phase I of the study.

  • AP or ACDrug

    Also called Pemetrexed/Cisplatin or Pemetrexed/Carboplatin

    Pemetrexed(A) 500mg/m2, IV, Day 1; Cisplatin(P) 25mg/m2,IV,Day 1-3 or Carboplatin(C) area under curve(AUC)=5, IV, Day 1; AP or AC will be administered every 21 days starting on Day 1.

  • Apatinib 250mgDrug

    Also called YN968D1

    250mg/d,q.d.,p.o.every 21 days.

  • Apatinib 500mgDrug

    Also called YN968D1

    500mg/d,q.d.,p.o.every 21 days.

  • Apatinib 750mgDrug

    Also called YN968D1

    750mg/d,q.d.,p.o.every 21 days.

Study groups in NCT03201146
Study groupRoleWhat they receive
Apatinib 750mg + AP or ACExperimentalPhase 1 study of Apatinib in combination with platinum-based doublet chemotherapy.
Receives: Drug: AP or AC; Drug: Apatinib 750mg
Apatinib 500mg + AP or ACExperimentalPhase 1 study of Apatinib in combination with platinum-based doublet chemotherapy.
Receives: Drug: AP or AC; Drug: Apatinib 500mg
Apatinib 250mg + AP or ACExperimentalPhase 1 study of Apatinib in combination with platinum-based doublet chemotherapy(PBDC).
Receives: Drug: AP or AC; Drug: Apatinib 250mg
ApatinibExperimentalPhase 2 study of Apatinib in combination with platinum-based doublet chemotherapy(PBDC).
Receives: Drug: Apatinib; Drug: AP or AC
AP or ACActive comparatorPemetrexed/Cisplatin(AP) or Pemetrexed/Carboplatin(AC), The platinum-based doublet chemotherapy, as the control group in the phase 2 study.
Receives: Drug: AP or AC

What is being measured

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

  1. Objective response rate(ORR)

    To determine ORR of Apatinib in combination with AP or AC in subjects with advanced EGFR wild type non-squamous non-small cell lung cancer. ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1

    Measured: Up to 36 months

Secondary outcomes (4)

  1. Progression-free survival (PFS)

    PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.

    Measured: Up to 36 months

  2. Disease Control Rate (DCR)

    Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.

    Measured: Up to 36 months

  3. median Overall Survival

    median Overall survival is defined as the time in months from the start of protocol treatment until the date of death, or the date of last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.

    Measured: Up to 36 months

  4. One-year Overall Survival Rate

    Kaplan Meier methods were used to estimate the 1-year survival probabilities for time to death from any cause. Estimates of the 1-year (365 day) survival probabilities and corresponding 95% confidence intervals (CI) were presented by treatment group.

    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.

  1. First posted28 Jun 2017
  2. Study start27 Jun 2017
  3. Primary completion1 Jul 2020 (estimated)
  4. Study completion1 Aug 2020 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03201146
Sponsor's protocol ID
2009L03464
Status last verified
Nov 2017
First submitted
25 Jun 2017
Last updated
17 Nov 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li J, Zhao X, Chen L, Guo H, Lv F, Jia K, Yv K, Wang F, Li C, Qian J, Zheng C, Zuo Y. Safety and pharmacokinetics of novel selective vascular endothelial growth factor receptor-2 inhibitor YN968D1 in patients with advanced malignancies. BMC Cancer. 2010 Oct 5;10:529. doi: 10.1186/1471-2407-10-529.

    PubMed 20923544

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Apatinib, AP or AC and Apatinib 250mg in people with Lung Cancer and Non Small Cell Lung Cancer, run by West China Hospital 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 14 inclusion and 25 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 17 Nov 2017. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 You Lu, MD (86-028-85422114, radyoulu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate(ORR) (time frame: Up to 36 months). 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 NCT03201146, which also lists 1 linked publication.

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 17 Nov 2017.

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