Stage IIIB Non-Small Cell Lung Cancer AJCC v7Phase 1NCT02503358
Selumetinib and Paclitaxel as Second-Line Treatment in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer
A Phase 1 study testing Laboratory Biomarker Analysis, Paclitaxel and Pharmacological Study in people with Stage IIIB Non-Small Cell Lung Cancer AJCC v7 and Stage IV Non-Small Cell Lung Cancer AJCC v7, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This randomized phase I trial is studying the side effects and the best dose of selumetinib when given together with paclitaxel as a second line therapy in treating patients with stage IIIB-IV non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IIIB Non-Small Cell Lung Cancer AJCC v7, Stage IV Non-Small Cell Lung Cancer AJCC v7
- What is being tested?
- Laboratory Biomarker Analysis, Paclitaxel and Pharmacological Study
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2016to 16 Jul 2020
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically and/or cytologically confirmed, non-small cell lung cancer (NSCLC) of adenocarcinoma histology at the time of initial diagnosis.
- Mixed tumors will be categorized by the predominant cell type; (Note: If small cell elements are present the patient is ineligible)
- Known mutational status of KRAS and BRAF oncogenes.
- For patients in whom mutational testing result is unknown or unavailable from a prior test, KRAS and BRAF testing will be performed (at a Clinical Laboratory Improvement Act (CLIA) -certified laboratory) using an archived or fresh biopsy as per standard of care, prior to enrollment.
- Stage IIIB-IV, locally advanced or metastatic disease according to the 7th edition of the American Joint Committee on Cancer (AJCC) lung cancer Tumor, Node, Metastasis (TNM) classification system
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Baseline measurements and evaluation of ALL sites of disease must be obtained within 4 weeks prior to enrollment.
Show all 28Show fewer
- Failure of at least one line of systemic anti-cancer therapy for advanced NSCLC defined as either of the following:
- Radiological documentation of disease progression (or failure to achieve a response) or
- Discontinuation due to toxicity
- Prior treatment with immunotherapy as well as maintenance therapy, including both continuation and switch maintenance will be allowed if received at least 14 days before start date of selumetinib-paclitaxel (immunotherapy is not allowed within 14 days of the start date of selumetinib-paclitaxel).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Estimated life expectancy, in the judgment of the investigator, which will permit receipt of treatment of 12 weeks or more
- Absolute neutrophil count >= 1.5x10^9 /L (1500 per mm^3)
- Platelets >= 100x10^9 /L (100,000 per mm^3)
- Hemoglobin > 9.0 g/dL
- Serum bilirubin < 1.5 x upper limit of normal (ULN) for institution [Exception: Patients who have elevated serum bilirubin due to underlying Gilbert's Syndrome or familial benign unconjugated hyperbilirubinemia are allowed.]
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) < 2.5 x upper limit of normal (ULN) for institution (or < 5.0 x ULN in presence of liver metastases)
- Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x upper limit of normal (ULN) for institution (or < 5.0 x ULN in presence of liver metastases).
- Adequate renal function as defined by one of the following:
- Serum creatinine <= 1.5 mg/dl OR
- Serum creatinine clearance > 50ml/min (calculated by Cockcroft-Gault formula).
- Females of child bearing potential that are sexually active must agree to either practice 2 medically accepted highly effective methods of contraception at the same time or abstain from heterosexual intercourse from the time of signing the informed consent through 30 days after the last dose of study drug.
- Negative test for pregnancy is required for females of child-bearing potential; A female of child bearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
- has not undergone a hysterectomy or bilateral oophorectomy; or
- has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months or 730 days).
- Conception while on treatment must be avoided
- Males of child bearing potential must agree to practice effective barrier contraception during the entire study treatment period and through 6 months) after the last dose of study drug, (includes males surgically sterilized (i.e. status post vasectomy).
- Ability to understand and the willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) document/s.
Who cannot join
- Known actionable mutations (e.g., EGFR, ALK, ROS1), against which there is available treatment. Patients who progressed on such treatment, i.e., have developed acquired resistance and are no longer reasonably expected to derive therapeutic benefit are eligible for the trial.
- Any prior treatment with either a MEK, RAS, or RAF inhibitor for advanced or metastatic NSCLC.
- A history of hypersensitivity to selumetinib, or any excipient agents (e.g. Captisol or TPGS- a water soluble form of vitamin E)
- Any unresolved toxicity > Common Terminology Criteria for Adverse Events (CTCAE) grade 2 despite optimal care/support, from previous anti-cancer therapy, except for alopecia, within 7 days prior to cycle 1, day 1.
- Cardiac conditions as follows:
- Uncontrolled hypertension (Blood Pressure (BP) >= 150/95 mmHg, despite medical therapy)
Show all 23Show fewer
- Left ventricular ejection fraction (LVEF) < 55%, measured by echocardiography
- Atrial fibrillation with a ventricular rate > 100 bpm on electrocardiogram (ECG) at rest
- Symptomatic heart failure New York Heart Association (NYHA ) grade II-IV)
- Prior or current cardiomyopathy
- Severe valvular heart disease
- Uncontrolled angina (Canadian Cardiovascular Society grade II-IV despite medical therapy)
- Acute coronary syndrome within 6 months prior to starting treatment
- Ophthalmological conditions as follows:
- Intra-ocular pressure > 21 mmHg, or uncontrolled glaucoma (irrespective of intra-ocular pressure)
- Current or past history of central serous retinopathy or retinal vein occlusion.
- Prior treatment with chemotherapy or immunotherapy within 14 days prior to enrollment. Subjects receiving palliative radiation to central nervous system (CNS) disease within 7 days may be eligible with PI approval. If the most recent treatment line is an EGFR-TKI, the washout period is a minimum of 3 days before the start of paclitaxel/selumetinib (i.e. treatment with the EGFR-TKI may continue until 3 days before start of study treatment). For other targeted therapy agents, the washout period will be 5 half-lives, prior to start of treatment on study.
- Major surgical procedure within 21 days prior to enrollment
- Brain metastases or spinal cord compression unless asymptomatic, treated and stable off steroids and anti-convulsants for at least 30 days
- Received an investigational drug within 30 days of starting treatment, or have not recovered from side effects of an investigational drug
- Female patients who are pregnant or breast-feeding (confirmation that the patient is not pregnant must be by a negative pregnancy test result obtained during screening; pregnancy testing is required of women of childbearing potential but not required for post-menopausal or surgically, sterilized women)
- Any evidence of severe or uncontrolled systemic disease, including, but not limited to, ongoing or active infection, active bleeding diatheses or renal transplant, including any patient known to have hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
- Serious medical or psychiatric illness/condition likely in the judgment of the investigator to interfere with compliance with protocol treatment/research
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: A Randomized, Open-Label, Phase I Trial of Continuous, Intermittent, and Pulsatile Selumetinib (AZD6244) Plus Paclitaxel as Second-Line Treatment for Stage IIIB or IV Non-small Cell Lung Cancer (NSCLC)
This randomized phase I trial is studying the side effects and the best dose of selumetinib when given together with paclitaxel as a second line therapy in treating patients with stage IIIB-IV non-small cell lung cancer (NSCLC). Selumetinib may stop or slow the growth of tumor cells by blocking a protein called mitogen-activated protein kinase (MEK) that is needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving selumetinib together with paclitaxel may kill more tumor cells.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the safety and tolerability of three pre-planned arms of continuous, intermittent, and pulsatile selumetinib with paclitaxel as second-line treatment in patients with stage IIIB or IV NSCLC.
SECONDARY OBJECTIVE:
- To determine the preliminary clinical response of continuous, intermittent, and pulsatile selumetinib with paclitaxel as second-line treatment in patients with stage IIIB or IV NSCLC.
EXPLORATORY OBJECTIVES:
II. To determine progression-free survival (PFS) and overall survival (OS) in patients treated with selumetinib/paclitaxel.
II. To assess correlations between cell-free deoxyribonucleic acid (DNA) (cfDNA) molecular features from blood and molecular features and pathways from the biopsy samples, and use this as a surrogate measure of tumor response and duration of response as evaluated in the primary and secondary objectives.
OUTLINE: This is a dose-finding study of selumetinib. The goal is to find out what dose and dosing schedule is the most effective in this population. Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients receive selumetinib orally (PO) twice daily (BID) on days 1-21 and paclitaxel intravenously (IV) over a fixed rate on days 1 and 8.
ARM II: Patients receive selumetinib PO BID on days 1-5, 8-12, and 15-19 and paclitaxel as in Arm I.
ARM III: Patients receive selumetinib PO BID on days 1-3, 8-10, and 15-17 and paclitaxel as in Arm I.
In all three arms, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing clinical benefit from study treatment may continue treatment based on the principal investigator (PI) approval on a patient-by-patient basis.
After completion of study treatment, patients are followed up at 30 days, every 8 weeks for 12 months, and then every 3 months thereafter.
- Conditions
- Stage IIIB Non-Small Cell Lung Cancer AJCC v7, Stage IV Non-Small Cell Lung Cancer AJCC v7
- Being tested
- Laboratory Biomarker Analysis, Paclitaxel, Pharmacological Study, Selumetinib
- 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.
Laboratory Biomarker AnalysisOther
Correlative studies
PaclitaxelDrug
Also called Anzatax, Asotax, Bristaxol, Praxel
Given IV
Correlative studies
SelumetinibDrug
Also called ARRY-142886, AZD6244, MEK Inhibitor AZD6244
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (continuous selumetinib and paclitaxel) | Experimental | Patients receive selumetinib PO BID on days 1-21 and paclitaxel IV over a fixed rate on days 1 and 8. Receives: Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Other: Pharmacological Study; Drug: Selumetinib |
| Arm II (intermittent selumetinib and paclitaxel) | Experimental | Patients receive selumetinib PO BID on days 1-5, 8-12, and 15-19 and paclitaxel as in Arm I. Receives: Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Other: Pharmacological Study; Drug: Selumetinib |
| Arm III (pulsatile selumetinib and paclitaxel) | Experimental | Patients receive selumetinib PO BID on days 1-3, 8-10, and 15-17 and paclitaxel as in Arm I. Receives: Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Other: Pharmacological Study; Drug: Selumetinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade 3 or higher treatment-related adverse event (AE) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Treatment arms will be summarized reporting the number of patients treated; the number who experience grade 3 or higher treatment-related AE. In addition, number of treatment cycles received will be summarized using descriptive statistics (median and range) by treatment arm. Comprehensive safety data on all toxicities will be tabulated by type, grade, duration, attribution to treatment, and treatment arm. A patient level summary by worst grade toxicity will be included. Laboratory data and concomitant medications associated with episodes of toxicity will be summarized as needed.
Measured: Up to 30 days post-treatment
Proportion of patients with treatment-related dose limiting toxicities (DLT) using the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Treatment arms will be summarized reporting the number of patients treated; the number who experience DLT; the number of patients who discontinue therapy, and the reasons for discontinuation. In addition, number of treatment cycles received will be summarized using descriptive statistics (median and range) by treatment arm. Comprehensive safety data on all toxicities will be tabulated by type, grade, duration, attribution to treatment, and treatment arm. A patient level summary by worst grade toxicity will be included.
Measured: 21 days
Proportion of patients with treatment-related serious adverse events (SAEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Treatment arms will be summarized reporting the number of patients treated; the number who experience SAEs. In addition, number of treatment cycles received will be summarized using descriptive statistics (median and range) by treatment arm. Comprehensive safety data on all toxicities will be tabulated by type, grade, duration, attribution to treatment, and treatment arm. A patient level summary by worst grade toxicity will be included. Laboratory data and concomitant medications associated with episodes of toxicity will be summarized as needed.
Measured: Up to 30 days post-treatment
Secondary outcomes (9)
Best response complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: Up to 4 years
Disease control rate (DCR)
DCR will be calculated as the proportion/percentage of patients with best overall response of CR, PR, or SD. Corresponding 95% confidence intervals, calculated by the binomial method, will be reported. In addition, patients in each response category (CR, PR, SD) will be summarized by descriptive statistics (median and range) with respect to time to onset of response and duration of response.
Measured: Up to 4 years
Median overall survival (OS)
The Kaplan-Meier method will be used to estimate OS per treatment arm.
Measured: From randomization to death or date of censoring, assessed at 6 months
Median overall survival (OS)
The Kaplan-Meier method will be used to estimate OS per treatment arm.
Measured: From randomization to death or date of censoring, assessed at 12 months
Median progression-free survival (PFS) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
The Kaplan-Meier method will be used to estimate PFS per treatment arm.
Measured: From randomization until documented disease progression or death (by any cause, in the absence of progression), assessed at 6 months
Median progression-free survival (PFS) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
The Kaplan-Meier method will be used to estimate PFS per treatment arm.
Measured: From randomization until documented disease progression or death (by any cause, in the absence of progression), assessed at 12 months
Objective response rate (ORR)
ORR will be estimated for the three pre-planned arms of selumetinib/paclitaxel. ORR will be calculated as the proportion/percentage of patients with best overall response of CR or PR.
Measured: Up to 4 years
Overall survival (OS)
The Kaplan-Meier method will be used to estimate OS per treatment arm.
Measured: From randomization to death or date of censoring, assessed up to 4 years post-treatment
Progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
The Kaplan-Meier method will be used to estimate PFS per treatment arm.
Measured: From randomization until documented disease progression or death (by any cause, in the absence of progression), assessed up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study start21 Jul 2016
- Primary completion16 Jul 2020
- Study completion16 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IIIB Non-Small Cell Lung Cancer AJCC v7Studies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University, AstraZeneca
- Responsible party
- Principal investigator, Brian Druker, OHSU Knight Cancer Institute
- Investigators
- Brian Druker, MD, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503358
- Sponsor's protocol ID
- IRB00011462
- Other IDs
- NCI-2015-01018, 11,462, SOL-15008-L, IRB00011462
- Status last verified
- Mar 2023
- First submitted
- 14 Jul 2015
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Phase I Trial of Continuous, Intermittent, and Pulsatile Selumetinib (AZD6244) Plus Paclitaxel as Second-Line Treatment for Stage IIIB or IV Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT02503358
- Acronym / sponsor ID
- IRB00011462
- Conditions
- Stage IIIB Non-Small Cell Lung Cancer AJCC v7, Stage IV Non-Small Cell Lung Cancer AJCC v7
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University, AstraZeneca
- Study start
- 21 Jul 2016 (actual)
- Primary completion
- 16 Jul 2020 (actual)
- Study completion
- 16 Jul 2020 (actual)
- First posted
- 21 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase I trial is studying the side effects and the best dose of selumetinib when given together with paclitaxel as a second line therapy in treating patients with stage IIIB-IV non-small cell lung cancer (NSCLC). Selumetinib may stop or slow the growth of tumor cells by blocking a protein called mitogen-activated protein kinase (MEK) that is needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving selumetinib together with paclitaxel may kill more tumor cells.
Detailed description
PRIMARY OBJECTIVE:
- To determine the safety and tolerability of three pre-planned arms of continuous, intermittent, and pulsatile selumetinib with paclitaxel as second-line treatment in patients with stage IIIB or IV NSCLC.
SECONDARY OBJECTIVE:
- To determine the preliminary clinical response of continuous, intermittent, and pulsatile selumetinib with paclitaxel as second-line treatment in patients with stage IIIB or IV NSCLC.
EXPLORATORY OBJECTIVES:
II. To determine progression-free survival (PFS) and overall survival (OS) in patients treated with selumetinib/paclitaxel.
II. To assess correlations between cell-free deoxyribonucleic acid (DNA) (cfDNA) molecular features from blood and molecular features and pathways from the biopsy samples, and use this as a surrogate measure of tumor response and duration of response as evaluated in the primary and secondary objectives.
OUTLINE: This is a dose-finding study of selumetinib. The goal is to find out what dose and dosing schedule is the most effective in this population. Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients receive selumetinib orally (PO) twice daily (BID) on days 1-21 and paclitaxel intravenously (IV) over a fixed rate on days 1 and 8.
ARM II: Patients receive selumetinib PO BID on days 1-5, 8-12, and 15-19 and paclitaxel as in Arm I.
ARM III: Patients receive selumetinib PO BID on days 1-3, 8-10, and 15-17 and paclitaxel as in Arm I.
In all three arms, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing clinical benefit from study treatment may continue treatment based on the principal investigator (PI) approval on a patient-by-patient basis.
After completion of study treatment, patients are followed up at 30 days, every 8 weeks for 12 months, and then every 3 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (continuous selumetinib and paclitaxel) | Experimental | Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Other: Pharmacological Study, Drug: SelumetinibPatients receive selumetinib PO BID on days 1-21 and paclitaxel IV over a fixed rate on days 1 and 8. |
| Arm II (intermittent selumetinib and paclitaxel) | Experimental | Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Other: Pharmacological Study, Drug: SelumetinibPatients receive selumetinib PO BID on days 1-5, 8-12, and 15-19 and paclitaxel as in Arm I. |
| Arm III (pulsatile selumetinib and paclitaxel) | Experimental | Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Other: Pharmacological Study, Drug: SelumetinibPatients receive selumetinib PO BID on days 1-3, 8-10, and 15-17 and paclitaxel as in Arm I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Histologically and/or cytologically confirmed, non-small cell lung cancer (NSCLC) of adenocarcinoma histology at the time of initial diagnosis.
- Stage IIIB-IV, locally advanced or metastatic disease according to the 7th edition of the American Joint Committee on Cancer (AJCC) lung cancer Tumor, Node, Metastasis (TNM) classification system
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Baseline measurements and evaluation of ALL sites of disease must be obtained within 4 weeks prior to enrollment.
- Failure of at least one line of systemic anti-cancer therapy for advanced NSCLC defined as either of the following:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (23 listed)
- Known actionable mutations (e.g., EGFR, ALK, ROS1), against which there is available treatment. Patients who progressed on such treatment, i.e., have developed acquired resistance and are no longer reasonably expected to derive therapeutic benefit are eligible for the trial.
- Any prior treatment with either a MEK, RAS, or RAF inhibitor for advanced or metastatic NSCLC.
- A history of hypersensitivity to selumetinib, or any excipient agents (e.g. Captisol or TPGS- a water soluble form of vitamin E)
- Any unresolved toxicity > Common Terminology Criteria for Adverse Events (CTCAE) grade 2 despite optimal care/support, from previous anti-cancer therapy, except for alopecia, within 7 days prior to cycle 1, day 1.
- Cardiac conditions as follows:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (continuous selumetinib and paclitaxel), Arm II (intermittent selumetinib and paclitaxel), Arm III (pulsatile selumetinib and paclitaxel) |
| PaclitaxelAlso: Anzatax, Asotax, Bristaxol, PraxelGiven IV | Drug | Arm I (continuous selumetinib and paclitaxel), Arm II (intermittent selumetinib and paclitaxel), Arm III (pulsatile selumetinib and paclitaxel) |
| Pharmacological StudyCorrelative studies | Other | Arm I (continuous selumetinib and paclitaxel), Arm II (intermittent selumetinib and paclitaxel), Arm III (pulsatile selumetinib and paclitaxel) |
| SelumetinibAlso: ARRY-142886, AZD6244, MEK Inhibitor AZD6244Given PO | Drug | Arm I (continuous selumetinib and paclitaxel), Arm II (intermittent selumetinib and paclitaxel), Arm III (pulsatile selumetinib and paclitaxel) |
Primary outcome
Incidence of grade 3 or higher treatment-related adverse event (AE) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time frame: Up to 30 days post-treatment
Treatment arms will be summarized reporting the number of patients treated; the number who experience grade 3 or higher treatment-related AE. In addition, number of treatment cycles received will be summarized using descriptive statistics (median and range) by treatment arm. Comprehensive safety data on all toxicities will be tabulated by type, grade, duration, attribution to treatment, and treatment arm. A patient level summary by worst grade toxicity will be included. Laboratory data and concomitant medications associated with episodes of toxicity will be summarized as needed.
Proportion of patients with treatment-related dose limiting toxicities (DLT) using the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time frame: 21 days
Treatment arms will be summarized reporting the number of patients treated; the number who experience DLT; the number of patients who discontinue therapy, and the reasons for discontinuation. In addition, number of treatment cycles received will be summarized using descriptive statistics (median and range) by treatment arm. Comprehensive safety data on all toxicities will be tabulated by type, grade, duration, attribution to treatment, and treatment arm. A patient level summary by worst grade toxicity will be included.
Proportion of patients with treatment-related serious adverse events (SAEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time frame: Up to 30 days post-treatment
Treatment arms will be summarized reporting the number of patients treated; the number who experience SAEs. In addition, number of treatment cycles received will be summarized using descriptive statistics (median and range) by treatment arm. Comprehensive safety data on all toxicities will be tabulated by type, grade, duration, attribution to treatment, and treatment arm. A patient level summary by worst grade toxicity will be included. Laboratory data and concomitant medications associated with episodes of toxicity will be summarized as needed.
9 secondary outcomes
Best response complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: Up to 4 years
Disease control rate (DCR)
Time frame: Up to 4 years
Median overall survival (OS)
Time frame: From randomization to death or date of censoring, assessed at 6 months
Median overall survival (OS)
Time frame: From randomization to death or date of censoring, assessed at 12 months
Median progression-free survival (PFS) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: From randomization until documented disease progression or death (by any cause, in the absence of progression), assessed at 6 months
Median progression-free survival (PFS) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: From randomization until documented disease progression or death (by any cause, in the absence of progression), assessed at 12 months
Objective response rate (ORR)
Time frame: Up to 4 years
Overall survival (OS)
Time frame: From randomization to death or date of censoring, assessed up to 4 years post-treatment
Progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: From randomization until documented disease progression or death (by any cause, in the absence of progression), assessed up to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
Related trials for Stage IIIB Non-Small Cell Lung Cancer AJCC v7
RecruitingPhase 2
Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
Advanced Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma
Active, not recruiting
Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)
Stage IB Lung Non-Small Cell Carcinoma AJCC v7, Stage II Lung Non-Small Cell Cancer AJCC v7
Active, not recruitingPhase 1/2
Veliparib With or Without Radiation Therapy, Carboplatin, and Paclitaxel in Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery
Lung Adenocarcinoma, Lung Adenocarcinoma, Mixed Subtype
Active, not recruitingPhase 2
A Phase 2 Study of Cediranib in Combination With Olaparib in Advanced Solid Tumors
Advanced Malignant Solid Neoplasm, Metastatic Lung Non-Small Cell Carcinoma
Active, not recruitingPhase 2
CHIO3 Trial: CHemotherapy Combined With Immune Checkpoint Inhibitor for Operable Stage IIIA/B Non-Small Cell Lung Cancer
Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Druker, MD principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Laboratory Biomarker Analysis, Paclitaxel and Pharmacological Study in people with Stage IIIB Non-Small Cell Lung Cancer AJCC v7 and Stage IV Non-Small Cell Lung Cancer AJCC v7, run by OHSU Knight Cancer Institute at 1 site in United States.
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 28 inclusion and 23 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: finished, as of the sponsor's last update on 21 Mar 2023. 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 United States. 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of grade 3 or higher treatment-related adverse event (AE) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (time frame: Up to 30 days post-treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2023.