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NSCLCPhase 3NCT03058094

A Study Comparing AC0010 and Chemotherapy in Patients With Advanced NSCLC Who Have Progressed Following Prior EGFR TKI

A Phase 3 study testing Pemetrexed, Cisplatin 75mg/m2 and AC0010 in people with NSCLC, run by Hangzhou ACEA Pharmaceutical Research Co., Ltd. at 21 sites in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

A Phase III, Open-Label, Randomized Multicenter Study to Compare AC0010 and Pemetrexed/Cisplatin in Patients With Advanced NSCLC Who Have Progressed Following Prior EGFR TKI. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
NSCLC
What is being tested?
Pemetrexed, Cisplatin 75mg/m2 and AC0010
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
21 sitesChina
Study dates
Dec 2018to Jan 2020
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, aged between 18-75 years old.
  • Histological or cytological confirmed diagnosis of locally or metastatic NSCLC (stage IIIB/IV).
  • Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.
  • Radiological proven disease progression while on first generation EGFR TKIs.
  • At least one measurable disease according to RECIST 1.1.
  • Confirmation of tumor EGFR sensitive mutation positive in previous tumor samples, including G719X, exon 19 deletion, L858R, L861Q.
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  • Confirmation of tumor harboring of T790M mutation by central lab with a biopsy sample taken after failure of first generation EGFR TKIs.
  • Adequate organ function:
  • Bone marrow reserve: Absolute neutrophil count ≥1.5 ´ 109/L,. Platelet count ≥100´ 109/L , Hemoglobin≥9 g/dL
  • Liver function: Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2.5 × the upper limit of normal (ULN) or <5 times ULN in the presence of liver metastases; Total bilirubin ≤1.5 × ULN
  • Kidney function: Creatinine ≤1.5 × ULN
  • Anti-cancer treatment prior to EGFR TKIs including chemotherapy, radiotherapy and other anti-cancer drugs for advanced stage is not allowed.
  • Resolved toxicities from prior therapy less than CTCAE grade 1 (except alopecia) and minimum 7 days of washout period from previous erlotinib, gefitinib or icotinib.
  • ECOG performance status 0 to1.
  • Life expectancy more than 3 months.
  • Patients without CNS metastases or asymptomatic patients with brain metastases. End of local therapy for brain metastases, including radiotherapy and surgery is required ≥28 days prior to beginning of screening.
  • Provision of signed informed consent.

Who cannot join

  • Undiagnosed by pathology.
  • HCV antibody positive, active hepatitis B (hepatitis B virus carrier can be recruited)
  • HIV antibody positive, other acquired immunodeficiency disease and congenital immunodeficiency disease. Patients with organ transplantation.
  • Patients received new aided/aided system therapy with palindromia in 12 months, the new aided/aieded system therapy is considered to be previous first-line treatment.
  • Condition of organ system:
  • Large field radiation or radiation field covered more than 30% bone marrow within 4 weeks of enrollment.
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  • A past history of interstitial lung disease, drug-induced interstitial lung disease or other active interstitial lung disease with clinical proof
  • Idiopathic pulmonary fibrosis (IPF).
  • In the investigator opinion, any severe or uncontrolled disease, such as unstable or uncontrolled respiratory, cardiovascular, liver or kidney diseases.
  • Any unstable system disease including refractory hypertension, unstable angina pectoris, congestive heart-failure, liver and renal disease, metabolic disease.
  • Patients with other malignant tumor in 5 years (except cured cervical carcinoma in situ, Basal cell carcinomas, squamous cell carcinoma)
  • A past history of neurological disorder or mental disorder including epilepsy and dementia.
  • Patients with chronic gastrointestinal diseases, inability to swallow medication, malabsorption syndrome or previous significant bowel resection that would preclude adequate absorption of AC0010.
  • Uncontrolled pleural and pericardial effusion.
  • Patients who have used high-dose glucocorticoids or other immunosuppressive agents within 1 month prior to screening.
  • Patient with symptomatic CNS metastases.
  • Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 6 months, heart block with second degree or greater, QTcB > 430ms（male）or > 450ms（female）.
  • Patients receiving medication known to prolong QT interval and potent inducers and inhibitors of CYP3A4 within 4 weeks of fist dose of AC0010.
  • Patients prove 1ml plasma to site's central lab after signing informed consent and the test results show the medication of AZD9291.
  • Patients who have been registered and received the study treatment or withdrawn from the study cannot be enrolled.
  • Patients receive unrelated surgery more than 14 days prior to the screening.
  • Pregnant and lactating women.
  • Women with childbearing potential are defined as all women who are physiologically able to have a pregnancy, unless they are using an efficient contraceptive method during treatment and within 7 days after discontinuation of treatment.
  • Men who have sexual intercourse unless they use a condom during sexual intercourse during treatment and 7 days after discontinuation of treatment and do not impregnate their sexual partners during the period. Vasectomized males are also required to use condoms to prevent the transmission of drugs through semen.
  • Patients who are considered by the investigator as inappropriate to participate in the study.

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

China21 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100000

  • Chinese General PLA Hospital

    Beijing, Beijing Municipality, 100000

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100000

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, 100021

  • Sichuan Cancer Hospital & Institute

    Chengdu, Sichuan, 610000

  • West China Hospital,Sichuan University

    Chengdu, Sichuan, 610000

  • Xinqiao Hospital Army Medical University

    Chongqing, Chongqing Municipality, 400000

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116000

  • The second Hospital of Dalian Medical University

    Dalian, Liaoning, 116000

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350000

  • Fuzhou General Hospital of Nanjing Military Command

    Fuzhou, Fujian, 350000

  • The First Affiliated Hospital,Zhejiang University

    Hangzhou, Zhejiang, 310000

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310000

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210000

  • Nanjing General Hospital

    Nanjing, Jiangsu, 210000

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110000

  • Tumor Hospital of Hebei Province

    Shijiazhuang, Hebei, 050000

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300000

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: A Phase III, Open-Label, Randomized Multicenter Study to Compare AC0010 and Pemetrexed/Cisplatin in Patients With Advanced NSCLC Who Have Progressed Following Prior EGFR TKI

A Phase III, Open-Label, Randomized Multicenter Study to Compare AC0010 and Pemetrexed/Cisplatin in Patients With Advanced NSCLC Who Have Progressed Following Prior EGFR TKI.

Read the detailed description

This is a phase III, open label, randomized study assessing AC0010 (300 mg, BID) versus pemetrexed/cisplatin (4-6 cycles) in patients with advanced NSCLC, who have progressed following prior therapy with EGFR-TKI.

Patients must provide a biopsy for central confirmation of T790M mutation positive. Eligible patients will be randomized (2:1) into AC0010 group or pemetrexed/cisplatin group. Patients in chemotherapy group can cross-over to AC0010 treatment when patients experience disease progression or intolerability of chemotherapy. The primary objective of the study is to compare the PFS of AC0010 and pemetrexed/cisplatin.

Conditions
NSCLC
Being tested
Pemetrexed, Cisplatin 75mg/m2, AC0010

What participants receive

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

  • PemetrexedDrug

    Also called Alimta

    Pemetrexed will be administered as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle. Folic acid will be administered 1-2 weeks prior to the 1st dose, then daily during the treatment period until 21days post the last dose. Vitamin B12 will be administered on the same day of pemetrexed infusion during the treatment period. Corticosteroid will be adminstered on the day prior to, on the day, and on the day after infusion.

  • Cisplatin 75mg/m2Drug

    Also called cis-platinum

    Cisplatin will be administered as an intravenous infusion.

  • AC0010Drug

    Also called AC0010MA

    300mg, orally, BID

Study groups in NCT03058094
Study groupRoleWhat they receive
AC0010ExperimentalAC0010, 300mg, orally, BID with a 21-day cycle
Receives: Drug: AC0010
ChemotherapyActive comparatorpemetrexed 500 mg/m2 + cisplatin 75 mg/m2 on day one of 21-day cycle, with total of 4-6 cycles.
Receives: Drug: Pemetrexed; Drug: Cisplatin 75mg/m2

What is being measured

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

  1. Progression-Free Survival (PFS)

    To assess the Progression-Free Survival (PFS) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).

    Measured: From the date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 24 months.

Secondary outcomes (5)

  1. Objective Response Rate (ORR)

    To assess the overall objective response rate (ORR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).

    Measured: Baseline up to 28 days after completion of study drug, assessed up to 24 months.

  2. Duration of Response (DoR)

    To assess the overall objective response rate (ORR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).

    Measured: From occurring of CR or PR until progression or the date of death from any cause, whichever came first, assessed up to 24 months.

  3. Disease Control Rate (DCR)

    To assess the Disease Control Rate (DCR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).

    Measured: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

  4. Overall Survival (OS)

    To assess the Overall Survival (OS) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).

    Measured: From the date of randomization to death or end of study, which is assessed up to 36 months.

  5. Patient Reported Outcomes by EORTC QLQ-C30 Questionnaire

    To assess the safety of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).

    Measured: Baseline up to 28 days after completion of study drug, assessed up to 24 months.

Timeline

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

  1. First posted20 Feb 2017
  2. Study startDec 2018 (estimated)
  3. Primary completionDec 2019 (estimated)
  4. Study completionJan 2020 (estimated)

Why it stopped: Considiering to change the Chemotherapy into Gefitinib

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03058094
Sponsor's protocol ID
AEGIS2:AC201602AVTN04
Status last verified
Jan 2019
First submitted
1 Dec 2016
Last updated
4 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pemetrexed, Cisplatin 75mg/m2 and AC0010 in people with NSCLC, run by Hangzhou ACEA Pharmaceutical Research Co., Ltd. at 21 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 17 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: withdrawn, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 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 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?

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: From the date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 24 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 NCT03058094.

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 4 Feb 2019.

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