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Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy

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ClinicalTrials.gov Identifier: NCT04253964
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : July 29, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE January 31, 2020
First Posted Date  ICMJE February 5, 2020
Last Update Posted Date July 29, 2020
Actual Study Start Date  ICMJE July 1, 2020
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2020)
Proportion of Participants with Progression-Free Survival [ Time Frame: From baseline to end of 4th cycle of treatment (12 weeks) ]
Using non-blinded central imaging using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 to define progressive disease.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2020)
  • Incidences of Grade 3 to Grade 5 Treatment-Related Adverse Events [ Time Frame: 12 weeks ]
    Adverse events will be defined using CTCAE Version 5.0 after four cycles (12 weeks).
  • Change in Overall Quality of Life/Global Health Status - EORTC QLQ-C30 [ Time Frame: From baseline to end of 4th cycle of treatment (12 weeks) ]
    Using the total score of the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), a 30-item questionnaire for functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, and nausea and vomiting), global health status and quality of life scale, also several single-item symptom measures. Scoring scale : 1 (Not at all) to 4 (Very much), 1 (Very poor) to 7 (Excellent). Minimum score 0, maximum score 100. For functional and global quality of life scales, higher scores mean a better level of functioning. For symptom-oriented scales, a higher score means more severe symptoms.
  • Proportion of Participants with Deterioration in Symptoms - QLQ-LC13 [ Time Frame: From baseline to end of 4th cycle of treatment (12 weeks) ]
    Patient reported deterioration in three symptoms: Cough, chest pain, or dyspnea as measured by the symptoms scales as part of the Quality of Life Questionnaire Lung Cancer Module (QLQ-LC13). Deterioration is defined as a 10-point or greater decrease from baseline in either cough, chest pain, or dyspnea and subsequently confirmed by a second adjacent 10-point or greater decrease from baseline in the same symptom)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy
Official Title  ICMJE Phase II Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-Small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy
Brief Summary This pilot study is configured as a non-inferiority comparison of Performance Status 2 patients with Performance Status 0-1 patients, with the goal of demonstrating non-inferiority in terms of efficacy (progression-free survival, overall survival) and safety (rates of adverse events, quality of life) when treating Performance Status 2 patients with the same first-line immunotherapy-based regimen as Performance Status 0-1 patients.
Detailed Description

Primary Objective: To demonstrate that proportion of Performance Status 2 participants with progression-free survival at 12 weeks is not inferior to the corresponding proportion of Performance Status 0-1 patients.

Secondary Objective(s)

  • To demonstrate that incidence of treatment-related adverse events at 12 weeks in the Performance Status 2 group is not higher than that occurring in the Performance Status 0-1 groups.
  • To demonstrate that change in overall quality of life/global health status at 12 weeks is not inferior in the Performance Status 2 group compared to the change in the Performance Status 0-1 group.
  • To demonstrate that proportion of participants with deterioration in lung-cancer specific symptoms at 12 weeks in the Performance Status 2 group is not higher than the corresponding proportion in the Performance Status 0-1 group.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Nonsmall Cell Lung Cancer
  • Performance Status
Intervention  ICMJE
  • Drug: Pembrolizumab
    ALL PARTICIPANTS: Pembrolizumab 200 mg intravenously (IV) on day 1 of each 3-week cycle for 4 cycles. Participants with predictive biomarker PD-L1 greater than or equal to 50% will not receive any other drugs besides pembrolizumab.
  • Drug: Carboplatin
    FOR PARTICIPANTS IN EITHER ARM with non-squamous OR squamous subtype, predictive biomarker PD-L1 less than 50%: Carboplatin area under the curve (AUC) 5 IV on day 1 of each 3-week cycle for 4 cycles.
  • Drug: Paclitaxel
    FOR PARTICIPANTS IN EITHER ARM with squamous subtype, predictive biomarker PD-L1 less than 50%: Paclitaxel 200 mg/m2 IV on day 1 of each 3-week cycle for 4 cycles.
  • Drug: Nab paclitaxel
    FOR PARTICIPANTS IN EITHER ARM with squamous subtype, predictive biomarker PD-L1 less than 50%: Nab-paclitaxel 100 mg/m2 on day 1, 8, 15 of 3-week cycle for 4 cycles.
  • Other: Quality of Life Questionnaire, lung cancer-specific (QLQ-LC13)
    The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.
  • Other: QLQ-C30 Global Health/Quality of Life Questionnaire
    30 item questionnaire - Functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, and nausea and vomiting), global health status and quality of life scale, also several single-item symptom measures
  • Other: COPD Assessment Test and modified Medical Research Council Dyspnea Patient Reported Outcomes
    Dyspnea scale scores in patients with respiratory disease (particularly COPD) to establish baseline functional dyspnea burden (taken pre-study at Week 0 and Post Treatment at week 13)
  • Drug: Pemetrexed
    FOR PARTICIPANTS IN EITHER ARM with nonsquamous subtype, predictive biomarker PD-L1 less than 50%: Pemetrexed 500 mg/m2 IV on day 1 of each 3-week cycle for 4 cycles.
Study Arms  ICMJE
  • Experimental: Performance Status 0-1 Participants

    ALL study participants will receive pembrolizumab 200 mg intravenously (IV) on day 1 of each 3-week cycle.

    Participants with predictive biomarker PD-L1 greater than or equal to 50%: Participants will not receive any other drugs besides pembrolizumab.

    Participants with Non-squamous subtype, predictive biomarker (PD-L1 less than 50%): Participants will ALSO receive:

    - Carboplatin area under the curve (AUC) 5 IV on day 1 of each 3-week cycle for 4 cycles.

    PLUS

    - Pemetrexed 500 mg/m2 IV on day 1 of each 3-week cycle for 4 cycles.

    Participants with Squamous subtype, predictive biomarker (PD-L1 less than 50%): Participants will also receive:

    • Carboplatin AUC 5 IV on day 1 of each 3-week cycle for 4 cycles. PLUS
    • Paclitaxel 200 mg/m2 IV on day 1 of each 3-week cycle for 4 cycles. OR
    • Nab-paclitaxel 100 mg/m2 on day 1, 8, 15 of 3-week cycle for 4 cycles
    Interventions:
    • Drug: Pembrolizumab
    • Drug: Carboplatin
    • Drug: Paclitaxel
    • Drug: Nab paclitaxel
    • Other: Quality of Life Questionnaire, lung cancer-specific (QLQ-LC13)
    • Other: QLQ-C30 Global Health/Quality of Life Questionnaire
    • Other: COPD Assessment Test and modified Medical Research Council Dyspnea Patient Reported Outcomes
    • Drug: Pemetrexed
  • Experimental: Performance Status 2 Participants

    ALL study participants will receive pembrolizumab 200 mg intravenously (IV) on day 1 of each 3-week cycle.

    Participants with predictive biomarker PD-L1 greater than or equal to 50%: Participants will not receive any other drugs besides pembrolizumab.

    Participants with Non-squamous subtype, predictive biomarker (PD-L1 less than 50%): Participants will ALSO receive:

    - Carboplatin area under the curve (AUC) 5 IV on day 1 of each 3-week cycle for 4 cycles.

    PLUS

    - Pemetrexed 500 mg/m2 IV on day 1 of each 3-week cycle for 4 cycles.

    Participants with Squamous subtype, predictive biomarker (PD-L1 less than 50%): Participants will also receive:

    • Carboplatin AUC 5 IV on day 1 of each 3-week cycle for 4 cycles. PLUS
    • Paclitaxel 200 mg/m2 IV on day 1 of each 3-week cycle for 4 cycles. OR
    • Nab-paclitaxel 100 mg/m2 on day 1, 8, 15 of 3-week cycle for 4 cycles
    Interventions:
    • Drug: Pembrolizumab
    • Drug: Carboplatin
    • Drug: Paclitaxel
    • Drug: Nab paclitaxel
    • Other: Quality of Life Questionnaire, lung cancer-specific (QLQ-LC13)
    • Other: QLQ-C30 Global Health/Quality of Life Questionnaire
    • Other: COPD Assessment Test and modified Medical Research Council Dyspnea Patient Reported Outcomes
    • Drug: Pemetrexed
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 31, 2020)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have histologically confirmed NSCLC that is metastatic or unresectable for which standard curative measures do not exist.
  • No prior systemic treatment with either chemotherapy or immunotherapy for non-curative intent. Patients may have previously received cancer treatment with curative intent for prior early stage disease.
  • At least 18 years old.
  • ECOG performance status of 0-2, as determined by the treating physician in the consult note.
  • Life expectancy of greater than 3 months.
  • Patients must have radiographically measurable metastatic disease by RECIST criteria.
  • Patients must have normal organ and marrow function as defined below:
  • absolute neutrophil count ≥1,000/mcL
  • platelets ≥100,000/mcL
  • Chemotherapy agents are known to be teratogenic, therefore 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 IRB-approved informed consent document.

Exclusion Criteria:

  • Nonsmall cell lung cancer that is known at registration to be positive for a tumor activating alteration for which first line targeted therapy is indicated; specifically, a targetable mutation in epidermal growth factor receptor (EGFR), gene rearrangement of anaplastic lymphoma kinase (ALK), gene rearrangement of c-ros oncogene 1 (ROS1), or mutation in B isoform of rapidly accelerated fibrosarcoma (B-Raf).
  • Known to have an active autoimmune disease that required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, systemic corticosteroids, or immunosuppressive drugs).
  • History of (non-infectious) pneumonitis that required systemic corticosteroids.
  • 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 from this study because of the potential for teratogenic or abortifacient effects with chemotherapy. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with chemotherapy, breastfeeding should be discontinued.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Nurse 336-716-2121 saverill@wakehealth.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04253964
Other Study ID Numbers  ICMJE IRB00063540
WFBCCC 62619 ( Other Identifier: Wake Forest Baptist Comprehensive Cancer Center )
P30CA012197 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Thomas Lycan, Jr., D.O., M.H.S. Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP