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Non Small Cell Lung CancerPhase 2NCT03123445

Endostar First-line Treatment of Advanced NSCLC

A Phase 2 study testing Endostar, Gemcitabine and Cisplatin in people with Non Small Cell Lung Cancer, run by China Medical University, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection pump combined GP（gemcitabine+cisplatin） scheme for first-line advanced non small cell lung cancer and maintenance treatment. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Endostar, Gemcitabine and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
No sites listed yet
Study dates
Apr 2017to Sep 2019
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

  • Cytological and histological confirmation（Do not accept single sputum cytology in the diagnosis of patients） in patients diagnosed of lung squamous carcinoma; According to a new IASLC (International Association for the Study of Lung Cance) 2009 lung cancer TNM (tumor node metastasis) stages judged stage IIIB or IV non-small cell lung cancer.
  • Must have at least one evaluated lesion,according to the RECIST version 1.1 standard (the longest diameter on spiral CT at least 10 mm,the longest diameter on plain CT at least 20 mm);
  • Male or female, age between 18 and 75 years old ;
  • ECOG(Eastern Cooperative Oncology Group) PS (performance status ) 0~1；
  • Expected survival period ≥ 3 months or more
  • Enough blood function: absolute neutrophil count (ANC)≥2 x 109 / L and the platelet count≥ 100 x 109 / L and hemoglobin ≥9 g/dL;
Show all 14Show fewer
  • Enough liver function: total bilirubin acuities≤the upper limit of normal (ULN); aspartate aminotransferase(AST) and Alanine aminotransferase(ALT) acuities ≤2.5 times of the upper limit of normal (ULN); Alkaline phosphatase ≤5 times of the upper limit of normal(ULN);
  • Enough renal function：serum creatinine ≤the limit of normal(ULN) or calculated creatinine clearance≥60 mL/min.
  • The electrocardiogram (ecg) basically normal,the body had no to heal wounds
  • No previous anti-tumor drug therapy, or only received for non metastatic tumor of adjuvant or neoadjuvant chemotherapy, but has ended more than six months before the study start.
  • Patients had surgery before,but have more than 4 weeks before the study start, and the patient has recovered;
  • Women with completed uterus before intact in the group within 28 days must have a negative pregnancy test results (unless amenorrhea for 24 months). If the pregnancy test from the first time for more than 7 days,the patients need for urine pregnancy test(within 7 days before the first delivery).
  • Prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions;
  • Sign the informed consent.

Who cannot join

  • Pregnancy, nursing mothers, or female patients with fertility but no contraception.
  • Existing serious acute infection, and can not be controlled; Or with fester sex and chronic infection,or wound in delay;
  • Original serious heart disease, including: congestive heart failure, uncontrolled high risk arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension;
  • With uncontrolled nerve, mental illness or mental disorders, compliance is poor, can't cooperate and response to treatment; Uncontrolled primary brain tumors or central nervous system(CNS) metastases illness, with obvious symptoms in cranial hypertension or nerve spirit;
  • With a bleeding tendency
  • Researchers believe that patients should not participate in this test.

Trial locations and contacts

No sites are listed yet.

liu yunpeng, PhD contact

00862483282312

cmu_trial@163.com

jin bo, PhD contact

00862483282542

jb_cmu@126.com

About this study

Official title: The Efficacy and Safety of Continuous Administration of Endostar Combined With Chemotherapy for Patients With Advanced no Small Cell Lung Cancer: An Open-label, no Randomized Controlled Multicenter Phase II Study

Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection pump combined GP（gemcitabine+cisplatin） scheme for first-line advanced non small cell lung cancer and maintenance treatment.

Read the detailed description

Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection pump combined GP（gemcitabine+cisplatin） scheme for first-line advanced non small cell lung cancer and maintenance treatment.

main objectives: PFS (progression-free survival) the secondary goal: ORR (overall response rate), DCR (disease control rate) and OS（overall survival）

Being tested
Endostar, Gemcitabine, Cisplatin
Keywords
endostar
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • EndostarDrug

    Also called Recombinant Human Endostatin Injection

    Endostar,30mg continuous intravenous injection pump, d1-d7,21 days as one cycle, 4 cycles in total

  • GemcitabineDrug

    Gemcitabine,1000mg/m2, i.v, d1 and d8 in each cycle, 21 days as one cycle, 4 cycles in total

  • CisplatinDrug

    Cisplatin,75mg/m2, i.v, d1 in each cycle, 21 days as one cycle, 4 cycles in total

Study groups in NCT03123445
Study groupRoleWhat they receive
Endostar + Gemcitabine and CisplatinExperimentalPatients in this group will be given endostar combined with gemcitabine and cisplatine.
Receives: Drug: Endostar; Drug: Gemcitabine; Drug: Cisplatin
Gemcitabine and CisplatinActive comparatorPatients in this group will be given gemcitabine and cisplatine.
Receives: Drug: Gemcitabine; Drug: Cisplatin

What is being measured

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

  1. Progression-free Survival (PFS)

    PFS is a tumor progression or death time of a patient who has an objective record on the date of enrollment. PFS calculation end if the patient was lost, unknown death , or other anti tumor therapy was used.

    Measured: Time Frame: up to month 36

Secondary outcomes (1)

  1. ORR

    overall remission rate

    Measured: Time Frame: change from Baseline at the week 6, 12 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase.

Timeline

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

  1. First posted21 Apr 2017
  2. Study startApr 2017 (estimated)
  3. Primary completionApr 2019 (estimated)
  4. Study completionSep 2019 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03123445
Sponsor's protocol ID
CLOG1701
Status last verified
Apr 2017
First submitted
5 Apr 2017
Last updated
21 Apr 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Wang J, Gu LJ, Fu CX, Cao Z, Chen QY. Endostar combined with chemotherapy compared with chemotherapy alone in the treatment of nonsmall lung carcinoma: A meta-analysis based on Chinese patients. Indian J Cancer. 2014 Mar;51 Suppl 3:e106-9. doi: 10.4103/0019-509X.154099.

    PubMed 25818734

  • Hu W, Fang J, Nie J, Dai L, Zhang J, Chen X, Ma X, Tian G, Wu D, Han S, Han J, Wang Y, Long J. Efficacy and safety of extended use of platinum-based doublet chemotherapy plus endostatin in patients with advanced nonsmall cell lung cancer. Medicine (Baltimore). 2016 Jul;95(28):e4183. doi: 10.1097/MD.0000000000004183.

    PubMed 27428214

  • Rong B, Yang S, Li W, Zhang W, Ming Z. Systematic review and meta-analysis of Endostar (rh-endostatin) combined with chemotherapy versus chemotherapy alone for treating advanced non-small cell lung cancer. World J Surg Oncol. 2012 Aug 24;10:170. doi: 10.1186/1477-7819-10-170.

    PubMed 22917490

  • Zhang FL, Gao EY, Shu RB, Wang H, Zhang Y, Sun P, Li M, Tang W, Jiang BQ, Chen SQ, Cui FB. Human Recombinant Endostatin Combined with Cisplatin Based Doublets in Treating Patients with Advanced NSCLC and Evaluation by CT Perfusion Imaging. Asian Pac J Cancer Prev. 2015;16(15):6765-8. doi: 10.7314/apjcp.2015.16.15.6765.

    PubMed 26434908

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Endostar, Gemcitabine and Cisplatin in people with Non Small Cell Lung Cancer, run by China Medical University, 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 6 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 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

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 liu yunpeng, PhD (00862483282312, cmu_trial@163.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: Time Frame: up to month 36). 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 NCT03123445, 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 21 Apr 2017.

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