Stage IV Non-Small Cell Lung Cancer Clinical Trial
Official title:
Phase II Pilot Study Evaluating Strategies to Overcome Resistance at the Time of Progression for Patients With Non-small Cell Lung Cancers Harboring Major Oncogenic Drivers
Verified date | January 2021 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase II trial studies how well targeted therapy works in treating patients with incurable non-small cell lung cancer with a genetic mutation. Giving drugs that target other genetic mutations or other specific proteins may work better when a patient has cancer caused by a driver mutation and the treatment that targets that mutation stops working.
Status | Terminated |
Enrollment | 19 |
Est. completion date | January 12, 2021 |
Est. primary completion date | January 8, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patients must have histologically or cytologically confirmed incurable non-small cell lung cancer that harbors an activating mutation in EGFR, MET, BRAF, V600E, RET, HER2, translocation in Alk, or translocation in ROS-1 - Patients must be receiving treatment or planning to start treatment with a tyrosine kinase inhibitor targeting the activated gene - Patients may not be receiving the treatment targeting the activated gene as part of a clinical treatment trial other than the Precision Oncology Trial - Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 - Total bilirubin =< 1.5 X institutional upper limit of normal - Aspartate transaminase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine transaminase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal - Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately - Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document Exclusion Criteria: - Emergent need for palliative radiation - Patients may not be receiving any other investigational agents for the treatment of non-small cell lung cancer - Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Pregnant women are excluded; breastfeeding should be discontinued |
Country | Name | City | State |
---|---|---|---|
United States | Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate in patients with high PD-L1 expressing cancers after failure of targeted therapy defined as complete or partial response according to the investigator's assessment | A Simon's two-stage design will be used. | Up to 3 years | |
Secondary | Incidence of adverse events measured using Common Terminology Criteria for Adverse Events version 4.0 | Toxicities for each group will be estimated and described using counts and frequencies by grade, location and relatedness. | Up to 30 days after the last dose of study treatment | |
Secondary | Incidence of mutations in secondary genes for patients with PD-L1 expression < 50% | Up to 3 years | ||
Secondary | Objective response rates for patients without high PD-L1 expressing cancers | Objective response rates will be estimates in the two PD-L1 expression < 50% arms. Confidence intervals for each of these rates will be estimated. An exploratory comparison will be made among the three groups comparing complete response/partial response versus stable disease/progressive disease among the groups using a Fisher's exact test (for the 2x3 table). | Up to 3 years | |
Secondary | Objective response rates for the combined population to historical controls receiving second or third line targeted agents | Objective response rates will be estimates in the two PD-L1 expression < 50% arms. Confidence intervals for each of these rates will be estimated. An exploratory comparison will be made among the three groups comparing complete response/partial response versus stable disease/progressive disease among the groups using a Fisher's exact test (for the 2x3 table). | Up to 3 years | |
Secondary | Overall survival | Estimated using Kaplan-Meier methods and survival rates will be compared using log-rank tests. | From date of progression on primary targeted treatment to death, assessed up to 3 years | |
Secondary | Rate of tobacco use and mutation burden based on PD-L1 expression at time of progression | Up to 3 years | ||
Secondary | Smoking status defined as current, former, never | Whether smoking status is related to the prevalence of any mutations identified (present/absent) will be examined using Cochran-Maentel Haenzel tests. These tests will be performed overall and then separately in the three arms. | At baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01664754 -
Exemestane, Pemetrexed Disodium, and Carboplatin in Treating Post-Menopausal Women With Stage IV Non-Small Cell Lung Cancer
|
Phase 1 | |
Completed |
NCT02451930 -
A Study of the Combination of Necitumumab (LY3012211) and Pembrolizumab (MK3475) in Participants With NSCLC
|
Phase 1 | |
Withdrawn |
NCT02106559 -
Photodynamic Therapy During Surgery in Treating Patients With Pleural Malignancy
|
N/A | |
Completed |
NCT02364609 -
Pembrolizumab and Afatinib in Patients With Non-small Cell Lung Cancer With Resistance to Erlotinib
|
Phase 1 | |
Terminated |
NCT02495896 -
Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Completed |
NCT01935336 -
Study of Ponatinib in Patients With Lung Cancer Preselected Using Different Candidate Predictive Biomarkers
|
Phase 2 | |
Withdrawn |
NCT01971489 -
Buparlisib, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT01839955 -
Erlotinib Hydrochloride and Quinacrine Dihydrochloride in Stage IIIB-IV Non-Small Cell Lung Cancer
|
Phase 1 | |
Terminated |
NCT01193868 -
RO4929097 in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Recently Completed Treatment With Front-Line Chemotherapy
|
Phase 2 | |
Completed |
NCT00986674 -
Carboplatin and Paclitaxel Combined With Cetuximab and/or IMC-A12 in Patients With Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
Completed |
NCT00963807 -
Trial Comparing the Use of FLT PET to Standard CT to Assess Treatment Response of Neoadjuvant Docetaxel and Cisplatin in Stage IB-IIIA Resectable NSCLC
|
Phase 2 | |
Completed |
NCT00085280 -
Erlotinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
|
N/A | |
Completed |
NCT00087412 -
S0341: Erlotinib in Treating Patients With Advanced Primary Non-Small Cell Lung Cancer
|
Phase 2 | |
Completed |
NCT00052338 -
Bortezomib Plus Gemcitabine and Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
|
Phase 1 | |
Completed |
NCT00006929 -
Suramin, Paclitaxel, and Carboplatin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
|
Phase 2 | |
Completed |
NCT02879994 -
Pembrolizumab in Treating Patients With EGFR Mutant, Tyrosine Kinase Inhibitor Naive Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
Completed |
NCT03305380 -
Radiomics to Identify Patients at Risk for Developing Pneumonitis, Differentiate Immune Checkpoint Inhibitor-induced Pneumonitis From Other Lung Inflammation and Distinguish Tumour Pseudo-progression From Real Tumour Growth
|
||
Completed |
NCT02728596 -
S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)
|
N/A | |
Completed |
NCT02858869 -
Pembrolizumab and Stereotactic Radiosurgery for Melanoma or Non-Small Cell Lung Cancer Brain Metastases
|
Phase 1 | |
Completed |
NCT02897375 -
Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors
|
Phase 1 |