Clinical Trials /

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

NCT04253964

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
  • Non-Squamous Non-Small Cell Lung Carcinoma
  • Squamous Cell Lung Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: WFBCCC 62619
  • NCT ID: NCT04253964

Conditions

  • Nonsmall Cell Lung Cancer
  • Performance Status

Interventions

DrugSynonymsArms
PembrolizumabPerformance Status 0-1 Participants
CarboplatinPerformance Status 0-1 Participants
PaclitaxelPerformance Status 0-1 Participants
Nab paclitaxelPerformance Status 0-1 Participants
PemetrexedPerformance Status 0-1 Participants

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Performance Status 0-1 ParticipantsExperimentalALL 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
  • Pembrolizumab
  • Carboplatin
  • Paclitaxel
  • Nab paclitaxel
  • Pemetrexed
Performance Status 2 ParticipantsExperimentalALL 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
  • Pembrolizumab
  • Carboplatin
  • Paclitaxel
  • Nab paclitaxel
  • Pemetrexed

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have histologically confirmed NSCLC that is metastatic or unresectable
             and for which standard curative or palliative measures do not exist or are no longer
             effective.

          -  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 indicated9;
             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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Proportion of Participants with Progression-Free Survival
Time Frame:From baseline to end of 4th cycle of treatment (12 weeks)
Safety Issue:
Description:Using non-blinded central imaging using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 to define progressive disease.

Secondary Outcome Measures

Measure:Incidences of Grade 3 to Grade 5 Treatment-Related Adverse Events
Time Frame:12 weeks
Safety Issue:
Description:Adverse events will be defined using CTCAE Version 5.0 after four cycles (12 weeks).
Measure: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)
Safety Issue:
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.
Measure:Proportion of Participants with Deterioration in Symptoms - QLQ-LC13
Time Frame:From baseline to end of 4th cycle of treatment (12 weeks)
Safety Issue:
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)

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Wake Forest University Health Sciences

Last Updated

January 31, 2020