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D-0316 in Patients With EGFR Positive Non Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03861156
Recruitment Status : Recruiting
First Posted : March 4, 2019
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
InventisBio Inc.

Brief Summary:
A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of D-0316 in Patients with Locally Advanced/Metastatic Non Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours are Epidermal Growth Factor Receptor Mutation and T790M Mutation Positive

Condition or disease Intervention/treatment Phase
Solid Tumor NSCLC EGFR T790M Drug: D-0316 Phase 2

Detailed Description:
This is a phase II, open label, single arm study assessing the safety and efficacy of D-0316 (Firstly, D-0316 was orally given 75mg for a cycle(21 days), if tolerated, the dose will be increased to 100mg. Otherwise, the dose will be maintained at 75mg.) in patients with a confirmed diagnosis of Epidermal Growth Factor Receptor mutation positive and T790M mutation positive NSCLC,who have progressed following prior therapy with an approved Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) agent. The primary objective of the study is to assess the efficacy of D-0316 by assessment of Objective Response Rate according to RECIST 1.1 by an Independent Central Review.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 286 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study to Assess the Safety and Efficacy of D-0316 in Patients With Locally Advanced/Metastatic Non Small Cell Lung Cancer Whose Tumors Are Epidermal Growth Factor Receptor Mutation Positive
Actual Study Start Date : February 22, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: D-0316
Firstly, D-0316 was orally given 75mg for a cycle(21 days), if tolerated, the dose will be increased to 100mg. Otherwise, the dose will be maintained at 75mg.
Drug: D-0316
Firstly, D-0316 was orally given 75mg for a cycle(21 days), if tolerated, the dose will be increased to 100mg. Otherwise, the dose will be maintained at 75mg.




Primary Outcome Measures :
  1. Objective response rate based on independent radiology review [ Time Frame: 24 months ]
    ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR).


Secondary Outcome Measures :
  1. Progression-free survival (PFS) as assessed by independent radiology review and investigator [ Time Frame: 36 months ]
    PFS, defined as time from first dose of X-396 to progression or death due to any cause.

  2. Overall survival (OS) [ Time Frame: 36 months ]
    OS, defined as time from first dose of X-396 to death due to any cause.

  3. Duration of response(DoR) [ Time Frame: 24 months ]
    DoR, defined as time from first reponse to disease progression or death

  4. Disease control rate(DCR) [ Time Frame: 24 months ]
    DCR, defined as proportion of complete response, partial response, and disease stabilization to the proportion of patients with evaluable tumors.

  5. Intracranial Progression-free survival(iPFS) [ Time Frame: 36 months ]
    iPFS, defined as the time between baseline brain metastases, from the date of study drug administration to the time between the onset of intracranial tumor progression or death.

  6. Intracranial objective response rate(iORR) [ Time Frame: 24 months ]
    iORR, defined as the proportion of subjects with complete intracranial response, partial intracranial response to subjects with brain metastases at baseline.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged at least 18 years.
  • Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic.
  • Radiological documentation of disease progression while on a previous continuous treatment with an first or second generation of EGFR TKI e.g. gefitinib or erlotinib.
  • patients must also have confirmation of tumour T790M mutation status (confirmed positive) after disease progression on the prior EGFR TKI.
  • Eastern cooperative oncology group performance status (ECOG PS) of 0-1.
  • a minimum life expectancy of 12 weeks.
  • At least one lesion, not previously irradiated during the study screening period, that can be accurately measured at baseline according to RECIST 1.1.
  • Agree to use routine adequate and effective contraceptive measures during the entire study period and within 6 weeks after the last dose pre-menopausal fertility possible; Female patients need to exclude pregnancy (ie negative pregnancy test) and in non-lactation period.

Exclusion Criteria:

  • Treatment with a first or second generation of EGFR-TKI within 10 days of study entry; previous treatment with a third generation of EGFR-TKI.
  • Unresolved toxicities from prior therapy.
  • Unstable spinal cord compression/brain metastases.
  • Severe/uncontrolled systemic diseases, including uncontrolled hypertension, bleeding diatheses or infection.
  • QTcF≥470 msec(female)or QTcF≥450 msec(male)during the screening period.
  • Severe respiratory diseases such as interstitial lung disease, severe asthma, pulmonary embolism, etc.
  • previous treatment with 2 or more lines of Chemotherapy or immunotherapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03861156


Contacts
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Contact: Shun Lu 021-22200000-2153 shun_lu@hotmail.com

Locations
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China, Shanghai
Shanghai Chest Hospital Recruiting
Shanghai, Shanghai, China, 200030
Contact: Shun Lu    021-22200000-2153    shun_lu@hotmail.com   
Contact: Shun Lu         
Sponsors and Collaborators
InventisBio Inc.
Investigators
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Study Chair: Shun Lu Shanghai Chest Hospital
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Responsible Party: InventisBio Inc.
ClinicalTrials.gov Identifier: NCT03861156    
Other Study ID Numbers: IBIO-102
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases