Try our beta test site

AZD9291 in Combination With Ascending Doses of Novel Therapeutics

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT02143466
First received: May 9, 2014
Last updated: January 23, 2017
Last verified: January 2017
  Purpose
The purpose of this study is to determine the safety, tolerability and preliminary anti-tumour activity of AZD9291 when given together with one of either MEDI4736, AZD6094 or selumetinib in patients with EGFR mutation positive advanced lung cancer

Condition Intervention Phase
Advanced Non Small Cell Lung Cancer
Drug: AZD9291 in combination with MEDI4736
Drug: AZD9291 in combination with AZD6094
Drug: AZD9291 in combinatin with selumetinib
Drug: AZD9291 in combination with selumetinib
Drug: Selumetinib Continuous (non-Asia only)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Multi-arm, Phase Ib, Open-Label, Multicentre Study to Assess the Safety,Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD9291 in Combination With Ascending Doses of Novel Therapeutics in Patients With EGFRm+ Advanced NSCLC Who Have Progressed Following Therapy With an EGFR TKI (TATTON).

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number of participants with Adverse Events and/or Dose Limiting Toxicities as a Measure of Safety and tolerability of AZD9291 when given in combination with MEDI4736, AZD6094 or selumetinib [ Time Frame: Adverse events will be collected from baseline until 28 days after the last dose in the AZD6094 or selumetinib arms and until 90 days after the last dose in the MEDI4736 arm, expected average of approximately 8.6 months ]
    Part A: To investigate the safety and tolerability of AZD9291 when given orally to patients with EGFRm+ NSCLC in combination with MEDI4736, AZD6094 or selumetinib who have progressed following prior therapy with an EGFR TKI agent, and define the combination dose(s) for further clinical evaluation.

  • Number of participants with Adverse Events as a measure of safety and tolerability and objective response rate as a measure of efficacy of AZD9291 when given in combination with AZD6094 or selumetinib [ Time Frame: Adverse events: baseline until 28 days after the last dose. ORR: baseline and every 6 weeks from time of first dose, participants will be followed by CT/MRI until disease progression or withdrawal from study, expected average of approximately 8.6 months ]
    Part B: To investigate the safety, tolerability and efficacy (Objective Response rate (ORR)) of AZD9291 when given in combination with AZD6094 or selumetinib in patients with locally advanced or metastatic NSCLC, who have progressed on a T790M directed EGFR TKI.


Secondary Outcome Measures:
  • Cmax after single dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified times on cycle 1 day 1 up to 24 hours ]
    To characterise the pharmacokinetics of AZD9291, AZD6094 or selumetinib and metabolites after single dosing and at steady state after multiple dosing when given orally to patients with EGFRm+ NSCLC in combination with AZD9291, AZD6094 or selumetinib through plasma concentrations. To characterise the PK, immunogenicity and pharmacodynamics of MEDI4736 after single dosing and at steady state after multiple dosing when given intravenously to patients with EGFRm+ NSCLC in combination with AZD9291 through plasma concentrations.

  • Tmax after single dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified on cycle 1 day 1 up to 24 hours ]
    To characterise the pharmacokinetics of AZD9291, AZD6094 or selumetinib and metabolites after single dosing and at steady state after multiple dosing when given orally to patients with EGFRm+ NSCLC in combination with AZD9291, AZD6094 or selumetinib through plasma concentrations. To characterise the PK, immunogenicity and pharmacodynamics of MEDI4736 after single dosing and at steady state after multiple dosing when given intravenously to patients with EGFRm+ NSCLC in combination with AZD9291 through plasma concentrations.

  • AUC after single dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified times on cycle 1 day 1 up to 24 hours ]
    To characterise the pharmacokinetics of AZD9291, AZD6094 or selumetinib and metabolites after single dosing and at steady state after multiple dosing when given orally to patients with EGFRm+ NSCLC in combination with AZD9291, AZD6094 or selumetinib through plasma concentrations. To characterise the PK, immunogenicity and pharmacodynamics of MEDI4736 after single dosing and at steady state after multiple dosing when given intravenously to patients with EGFRm+ NSCLC in combination with AZD9291 through plasma concentrations.

  • AUC0-t after single dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified on cycle 1 day 1 up to 24 hours ]
    To characterise the pharmacokinetics of AZD9291, AZD6094 or selumetinib and metabolites after single dosing and at steady state after multiple dosing when given orally to patients with EGFRm+ NSCLC in combination with AZD9291, AZD6094 or selumetinib through plasma concentrations. To characterise the PK, immunogenicity and pharmacodynamics of MEDI4736 after single dosing and at steady state after multiple dosing when given intravenously to patients with EGFRm+ NSCLC in combination with AZD9291 through plasma concentrations.

  • AUC0-24 after single dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified times on cycle 1 day 1 up to 24 hours ]
    To characterise the pharmacokinetics of AZD9291, AZD6094 or selumetinib and metabolites after single dosing and at steady state after multiple dosing when given orally to patients with EGFRm+ NSCLC in combination with AZD9291, AZD6094 or selumetinib through plasma concentrations. To characterise the PK, immunogenicity and pharmacodynamics of MEDI4736 after single dosing and at steady state after multiple dosing when given intravenously to patients with EGFRm+ NSCLC in combination with AZD9291 through plasma concentrations.

  • Terminal half life after single dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified times on cycle 1 day 1 up to 24 hours ]
    To characterise the pharmacokinetics of AZD9291, AZD6094 or selumetinib and metabolites after single dosing and at steady state after multiple dosing when given orally to patients with EGFRm+ NSCLC in combination with AZD9291, AZD6094 or selumetinib through plasma concentrations. To characterise the PK, immunogenicity and pharmacodynamics of MEDI4736 after single dosing and at steady state after multiple dosing when given intravenously to patients with EGFRm+ NSCLC in combination with AZD9291 through plasma concentrations.

  • CL after single dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified times on cycle 1 day 1 up to 24 hours ]
    To characterise the PK, immunogenicity and pharmacodynamics of MEDI4736 after single dosing and at steady state after multiple dosing when given intravenously to patients with EGFRm+ NSCLC in combination with AZD9291 through plasma concentrations.

  • CL/f after single dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified times on cycle 1 day 1 up to 24 hours ]
    To characterise the pharmacokinetics of AZD9291, AZD6094 or selumetinib and metabolites after single dosing and at steady state after multiple dosing when given orally to patients with EGFRm+ NSCLC in combination with AZD9291, AZD6094 or selumetinib through plasma concentrations.

  • Volume of distribution after single dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified times on cycle 1 day 1 up to 24 hours ]
    To characterise the pharmacokinetics of AZD9291, AZD6094 or selumetinib and metabolites after single dosing and at steady state after multiple dosing when given orally to patients with EGFRm+ NSCLC in combination with AZD9291, AZD6094 or selumetinib through plasma concentrations. To characterise the PK, immunogenicity and pharmacodynamics of MEDI4736 after single dosing and at steady state after multiple dosing when given intravenously to patients with EGFRm+ NSCLC in combination with AZD9291 through plasma concentrations.

  • Cssmax after multiple dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified times on cycle 2 day 1 up to 24 hours ]
    To characterise the pharmacokinetics of AZD9291, AZD6094 or selumetinib and metabolites after single dosing and at steady state after multiple dosing when given orally to patients with EGFRm+ NSCLC in combination with AZD9291, AZD6094 or selumetinib through plasma concentrations. To characterise the PK, immunogenicity and pharmacodynamics of MEDI4736 after single dosing and at steady state after multiple dosing when given intravenously to patients with EGFRm+ NSCLC in combination with AZD9291 through plasma concentrations.

  • Tssmax after multiple dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified times on cycle 2 day 1 up to 24 hours ]
    To characterise the pharmacokinetics of AZD9291, AZD6094 or selumetinib and metabolites after single dosing and at steady state after multiple dosing when given orally to patients with EGFRm+ NSCLC in combination with AZD9291, AZD6094 or selumetinib through plasma concentrations. To characterise the PK, immunogenicity and pharmacodynamics of MEDI4736 after single dosing and at steady state after multiple dosing when given intravenously to patients with EGFRm+ NSCLC in combination with AZD9291 through plasma concentrations.

  • Cssmin after multiple dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified times for the duration of treatment, expected to be 7.5 months ]
    To characterise the pharmacokinetics of AZD9291, AZD6094 or selumetinib and metabolites after single dosing and at steady state after multiple dosing when given orally to patients with EGFRm+ NSCLC in combination with AZD9291, AZD6094 or selumetinib through plasma concentrations. To characterise the PK, immunogenicity and pharmacodynamics of MEDI4736 after single dosing and at steady state after multiple dosing when given intravenously to patients with EGFRm+ NSCLC in combination with AZD9291 through plasma concentrations.

  • AUCss after multiple dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified times on cycle 2 day 1 up to 24 hours ]
    To characterise the pharmacokinetics of AZD9291, AZD6094 or selumetinib and metabolites after single dosing and at steady state after multiple dosing when given orally to patients with EGFRm+ NSCLC in combination with AZD9291, AZD6094 or selumetinib through plasma concentrations. To characterise the PK, immunogenicity and pharmacodynamics of MEDI4736 after single dosing and at steady state after multiple dosing when given intravenously to patients with EGFRm+ NSCLC in combination with AZD9291 through plasma concentrations.

  • CLss/f after multiple dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified times on cycle 2 day 1 up to 24 hours ]
    To characterise the pharmacokinetics of AZD9291, AZD6094 or selumetinib and metabolites after single dosing and at steady state after multiple dosing when given orally to patients with EGFRm+ NSCLC in combination with AZD9291, AZD6094 or selumetinib through plasma concentrations. To characterise the PK, immunogenicity and pharmacodynamics of MEDI4736 after single dosing and at steady state after multiple dosing when given intravenously to patients with EGFRm+ NSCLC in combination with AZD9291 through plasma concentrations.

  • Rac after multiple dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified times on cycle 1 day 1 and cycle 2 day 1 ]
    To characterise the pharmacokinetics of AZD9291, AZD6094 or selumetinib and metabolites after single dosing and at steady state after multiple dosing when given orally to patients with EGFRm+ NSCLC in combination with AZD9291, AZD6094 or selumetinib through plasma concentrations. To characterise the PK, immunogenicity and pharmacodynamics of MEDI4736 after single dosing and at steady state after multiple dosing when given intravenously to patients with EGFRm+ NSCLC in combination with AZD9291 through plasma concentrations.

  • Time dependency of PK after multiple dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified times on cycle 1 day 1 and cycle 2 day 1 ]
    To characterise the pharmacokinetics of AZD9291, AZD6094 or selumetinib and metabolites after single dosing and at steady state after multiple dosing when given orally to patients with EGFRm+ NSCLC in combination with AZD9291, AZD6094 or selumetinib through plasma concentrations. To characterise the PK, immunogenicity and pharmacodynamics of MEDI4736 after single dosing and at steady state after multiple dosing when given intravenously to patients with EGFRm+ NSCLC in combination with AZD9291 through plasma concentrations.

  • Best objective response [ Time Frame: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 7.5 months ]
    To obtain a preliminary assessment of the anti-tumour activity of the combination of AZD9291 and MEDI4736, AZD6094 or selumetinib by evaluation of tumour response (objective response rate, duration of response, change in tumour size) and progression free survival using RECIST version 1.1 (modified for MEDI4736 cohorts)

  • Objective response rate [ Time Frame: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 7.5 months ]
    To obtain a preliminary assessment of the anti-tumour activity of the combination of AZD9291 and MEDI4736, AZD6094 or selumetinib by evaluation of tumour response (objective response rate, duration of response, change in tumour size) and progression free survival using RECIST version 1.1 (modified for MEDI4736 cohorts)

  • Disease control rate [ Time Frame: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 7.5 months ]
    To obtain a preliminary assessment of the anti-tumour activity of the combination of AZD9291 and MEDI4736, AZD6094 or selumetinib by evaluation of tumour response (objective response rate, duration of response, change in tumour size) and progression free survival using RECIST version 1.1 (modified for MEDI4736 cohorts)

  • Duration of response [ Time Frame: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 7.5 months ]
    To obtain a preliminary assessment of the anti-tumour activity of the combination of AZD9291 and MEDI4736, AZD6094 or selumetinib by evaluation of tumour response (objective response rate, duration of response, change in tumour size) and progression free survival using RECIST version 1.1 (modified for MEDI4736 cohorts)

  • Percentage change in tumour size [ Time Frame: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 7.5 months ]
    To obtain a preliminary assessment of the anti-tumour activity of the combination of AZD9291 and MEDI4736, AZD6094 or selumetinib by evaluation of tumour response (objective response rate, duration of response, change in tumour size) and progression free survival using RECIST version 1.1 (modified for MEDI4736 cohorts)

  • Progression free survival [ Time Frame: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 7.5 months ]

    To obtain a preliminary assessment of the anti-tumour activity of the combination of AZD9291 and MEDI4736, AZD6094 or selumetinib by evaluation of tumour response (objective response rate, duration of response, change in tumour size) and progression free survival using RECIST version 1.1 (modified for MEDI4736 cohorts)

    Expansion phase only


  • Safety, tolerability and efficacy of AZD9291 when given in combination with MEDI4736 [ Time Frame: Adverse events will be collected from baseline until 90 days after the last dose, expected average 7.5 months ]
    To investigate the safety, tolerability and prliminary efficacy of AZD9291 when given in combination with MEDI4736 as 1st line therapy to patients who are treatment naive for locally advanced or metastatic EGFRm+ NSCLC.


Estimated Enrollment: 198
Study Start Date: August 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEDI4736
AZD9291 in combination with MEDI4736
Drug: AZD9291 in combination with MEDI4736
AZD9291 and MEDI4736 will be administered. Part A: If initial dosing is tolerated then subsequent cohorts will test increasing doses of AZD9291 and/or MEDI4736, until a recommended dose for further clinical evaluation is defined. Part B: The recommended dose from Part A will be further evaluated in an expansion cohort.
Other Name: AZD9291 & MEDI4736
Experimental: AZD6094
AZD9291 in combination with AZD6094
Drug: AZD9291 in combination with AZD6094
AZD9291 and AZD6094 will be administered in combination. Part A: If tolerated, subsequent cohorts will test increasing doses of AZD9291 and/or AZD6094, until a recommended dose for further clinical evaluation is defined. Part B: The recommended dose from Part A will be further evaluated in an expansion cohort.
Other Name: AZD9291 & Savolitinib, Volitinib
Experimental: Selumetinib Continuous (Asia only)
AZD9291 in combination with selumetinib
Drug: AZD9291 in combinatin with selumetinib
AZD9291 and selumetinib will be administered in combination. Part A: If tolerated, subsequent cohorts will test increasing doses of AZD9291 and/or selumetinib, until a recommended dose for further clinical evaluation is defined. Part B: The recommended dose from Part A may be further evaluated in an expansion cohort.
Other Name: AZD9291 & ARRY-142886
Experimental: Selumetinib Intermittent
AZD9291 in combination with selumetinib
Drug: AZD9291 in combination with selumetinib
AZD9291 will be administered with intermittent doses of selumetinib. Part A: If tolerated, subsequent cohorts will test increasing doses of AZD9291 and/or selumetinib, until a recommended dose for further clinical evaluation is defined. Part B: The recommended dose from Part A may be further evaluated in an expansion cohort.
Other Name: AZD9291 & ARRY-142886
Experimental: Selumetinib Continuous (non-Asia only)
AZD9291 in combination with Selumetinib
Drug: Selumetinib Continuous (non-Asia only)
AZD9291 and selumetinib will be administered in combination. Part A: If tolerated, subsequent cohorts will test increasing doses of AZD9291 and/or selumetinib, until a recommended dose for further clinical evaluation is defined. Part B: The recommended dose from Part A may be further evaluated in an expansion cohort.
Other Name: AZD9291 & ARRY-142886

Detailed Description:

This is a Phase Ib, open-label, multicentre study of AZD9291 administered orally in combination with novel therapeutics (MEDI4736, AZD6094 or selumetinib (AZD6244, ARRY142886)

) to patients with EGFRm+ advanced NSCLC. The study has been designed to allow an investigation of the optimal combination dose and schedule whilst ensuring the safety of patients with intensive safety monitoring. There are two parts to this study. Part A, Combination dose finding and Part B, Dose expansion.

AZD9291 is a potent irreversible inhibitor of both the single Epidermal Growth Factor Receptor (EGFR) mutation positive (Tyrosine Kinase Inhibitor [TKI]-sensitivity conferring mutations, EGFRm+) and T790M positive (TKI-resistance conferring mutation, T790M+) receptor forms of the EGFR with a wide margin of selectivity against EGFR wild-type (WT).

AZD9291 acts on cancer by blocking abnormal EGFR-mediated signalling, leading to profound tumour growth inhibition in EGFR mutation bearing xenografts of non-small cell lung cancer (NSCLC) tumours. Preliminary data from a large phase I study (study D5160C00001) has provided data on the safety and clinical activity of monotherapy AZD9291 in this patient population.

  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses. Aged at least 18 years. Patients from Japan aged at least 20 years. Histological or cytological confirmation diagnosis of EGFRm+ Non Small Cell Lung Cancer (NSCLC) and for T790M directed EGFR TKI patients only: Documented T790M positive status when the patient started on the previous T790M directed EGFR TKI.

With the exception of 1st line patients: Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI. In addition other lines of therapy may have been given. These patients must have documented radiological progression on the last treatment administered prior to enrolling in the study.

Confirmation from a previous archival sample that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including exon 19 deletion and L858R).

Part B cMET+ve patients

2nd line cohort: only one prior line of therapy, which must be an EGFR TKI, but not a T790M-directed agent

≥3rd line cMET+ve cohort: Patients must have received at least two prior lines of therapy, including at least one prior EGFR TKI (T790M directed agents are permitted)

Part B cMET-ve patients

T790M directed EGFR TKI patients only: their immediate prior therapy before entry into this study must be a T790M directed EGFR TKI

≥2nd line cohort: Patients must have progressed while on treatment with an EGFR TKI (T790M directed EGFR TKIs are permitted). Other prior lines of therapy may have been given

At least one lesion that can be used as a measurable lesion for the purposes of RECIST assessments WHO performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks

Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing or evidence of non-child bearing potential.Male patients should be willing to use barrier contraception

Exclusion Criteria:

Treatment with an EGFR TKI within approximately 5x half-life of the first dose of study treatment. Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment. AZD9291 in the present study (ie, dosing previously initiated in this study). Prior or current exposure to or treatment with any anti-PD-L1 or anti-PD-1 antibodies if allocated to MEDI4736 or tremelimumab and prior or current exposure to AZD6094 or another cMet inhibitor or selumetinib or any MEK, RAS or RAF inhibitor if allocated to AZD6094 or selumetinib respectively.

Current leptomeningeal metastases or spinal cord compression. Brain metastases are only permitted if treated, asymptomatic, and stable (not requiring steroids for at least 4 weeks prior to start of study treatment).

Cardiac disease

Ophthalmological conditions

Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection.

Inadequate bone marrow reserve or organ function

Inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.

Additional Exclusion criteria for MEDI4736

Active or prior documented autoimmune or inflammatory disease within the past 3 years.History of organ transplant that requires use of immunosuppressive medications including, but not limited to systemic corticosteroids at doses beyond 10 mg/day of prednisone or equivalent, methotrexate, azathioprine, and tumour necrosis factor alpha (TNF-α) blockers.

Current or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736

History of sarcoidosis syndrome. Known history of tuberculosis. Receipt of live, attenuated vaccine within 30 days prior to the first dose of MEDI4736

Additional Exclusion criteria for AZD6094

Patients currently receiving (or unable to stop use at least 1 week) prior to receiving the first dose of AZD6094, medications known to be strong inhibitors of CYP1A2 and CYP3A4

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02143466

Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Contact: Cancer Study Locator 877 400 4656 AstraZeneca@emergingmed.com

Locations
United States, Georgia
Research Site Recruiting
Atlanta, Georgia, United States
United States, Massachusetts
Research Site Recruiting
Boston, Massachusetts, United States
United States, New York
Research Site Recruiting
New York, New York, United States
United States, Tennessee
Research Site Recruiting
Nashville, Tennessee, United States
United States, Texas
Research Site Withdrawn
Houston, Texas, United States
Japan
Research Site Recruiting
Chuo-ku, Japan
Research Site Recruiting
Habikino-shi, Japan
Research Site Recruiting
Hirakata-shi, Japan
Research Site Recruiting
Kashiwa-shi, Japan
Research Site Recruiting
Nagoya-shi, Japan
Korea, Republic of
Research Site Recruiting
Cheongju-si, Korea, Republic of
Research Site Recruiting
Goyang-si, Korea, Republic of
Research Site Recruiting
Seongnam-si, Korea, Republic of
Research Site Recruiting
Seoul, Korea, Republic of
Taiwan
Research Site Not yet recruiting
Kaohsiung, Taiwan
Research Site Recruiting
Tainan, Taiwan
Research Site Recruiting
Taipei, Taiwan
Research Site Not yet recruiting
Taipei, Taiwan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Jenny Yang AstraZeneca
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02143466     History of Changes
Other Study ID Numbers: D5160C00006
Study First Received: May 9, 2014
Last Updated: January 23, 2017

Keywords provided by AstraZeneca:
Phase I
Safety
Tolerability
Efficacy
Anti-tumour
AZD9291
Osimertinib
MEDI4736
Durvalumab
AZD6094
Savolitinib
Selumetinib
Ascending Doses
Expansion cohorts
EGFR
Advanced Non-Small Cell Lung Cancer
Tyrosine Kinase Inhibitors

Additional relevant MeSH terms:
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
Osimertinib
Coal Tar
Antibodies, Monoclonal
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Keratolytic Agents
Dermatologic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 22, 2017