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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

Primary Purpose

Nonsmall Cell Lung Cancer, Performance Status

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pembrolizumab
Carboplatin
Paclitaxel
Nab paclitaxel
Quality of Life Questionnaire, lung cancer-specific (QLQ-LC13)
QLQ-C30 Global Health/Quality of Life Questionnaire
COPD Assessment Test and modified Medical Research Council Dyspnea Patient Reported Outcomes
Pemetrexed
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonsmall Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must have a cytological or histological diagnosis of non-small cell lung cancer 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.

Sites / Locations

  • Wake Forest Baptist Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Performance Status 0-1 Participants

Performance Status 2 Participants

Arm Description

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

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

Outcomes

Primary Outcome Measures

Proportion of Participants with Progression-Free Survival
Using non-blinded central imaging using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 to define progressive disease.

Secondary Outcome Measures

Incidences of Grade 3 to Grade 5 Treatment-Related Adverse Events
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
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
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)

Full Information

First Posted
January 31, 2020
Last Updated
December 19, 2022
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04253964
Brief Title
Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy
Official Title
Phase II Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-Small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonsmall Cell Lung Cancer, Performance Status

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Performance Status 0-1 Participants
Arm Type
Experimental
Arm Description
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
Arm Title
Performance Status 2 Participants
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Nab paclitaxel
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Quality of Life Questionnaire, lung cancer-specific (QLQ-LC13)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
QLQ-C30 Global Health/Quality of Life Questionnaire
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
COPD Assessment Test and modified Medical Research Council Dyspnea Patient Reported Outcomes
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of Participants with Progression-Free Survival
Description
Using non-blinded central imaging using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 to define progressive disease.
Time Frame
From baseline to end of 4th cycle of treatment (12 weeks)
Secondary Outcome Measure Information:
Title
Incidences of Grade 3 to Grade 5 Treatment-Related Adverse Events
Description
Adverse events will be defined using CTCAE Version 5.0 after four cycles (12 weeks).
Time Frame
12 weeks
Title
Change in Overall Quality of Life/Global Health Status - EORTC QLQ-C30
Description
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.
Time Frame
From baseline to end of 4th cycle of treatment (12 weeks)
Title
Proportion of Participants with Deterioration in Symptoms - QLQ-LC13
Description
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)
Time Frame
From baseline to end of 4th cycle of treatment (12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have a cytological or histological diagnosis of non-small cell lung cancer 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Nurse
Phone
336-716-2121
Email
saverill@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Lycan, Jr., D.O., M.H.S.
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Nurse
Email
saverill@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Thomas Lycan, Jr., DO, MHS

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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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