The purpose of this research study is to test the effectiveness of three treatment arms that are designed to improve survival in patients with non-small cell lung cancer. Eligible subjects could be randomized to four (4) cycles of chemotherapy followed by immunotherapy, or immunotherapy followed by chemotherapy, or four cycles of chemotherapy plus immunotherapy.
This open-label, three-arm, non-comparative randomized phase II study is designed to evaluate three different sequences of double-consolidation with the humanized monoclonal antibody targeted against cell surface receptor programmed cell death-1 (PD-1), pembrolizumab, and nab-paclitaxel in patients with advanced Non small cell lung cancer post induction chemotherapy. While the goal of each arm is to guarantee exposure to each of these two agents to patients who have not progressed post induction chemotherapy, they do so with different sequence. In ARMs A and B, consolidation is sequential, with either pembrolizumab followed by nab-paclitaxel (ARM A), or nab-paclitaxel followed by pembrolizumab (ARM B). In ARM C, consolidation is concurrent, with the two agents administered concurrently. As of July 24, ARMs B and C are closed, and no patients will be enrolled on this study. ARM A remains open to enrollment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles. Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
UNC Lineberger Comprehsive Cancer Center
Chapel Hill, North Carolina, United States
Rex Cancer Center
Raleigh, North Carolina, United States
Rex Cancer Center of Wakefield
Raleigh, North Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Overall Survival
Overall survival is defined as the time from day 1 of treatment to death from any cause. Median overall survival was calculated for each arm.
Time frame: Up to 60 months
Progression Free Survival (PFS)
PFS is defined as the time from first day of treatment until disease progression as defined by the response evaluation criteria in solid tumors (RECIST 1.1) and and Immune Related Response Criteria (irRC), or death from any cause death or progression. RECIST 1.1 Progressive Disease (PD): \>= 20% increase in the sum of the LD of the target lesions, Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, Nonprogressive disease (NPD): No measurable disease at the entrance of the study or otherwise non measurable disease will be assessed for progression. irRC Progressive Disease (irPD), ≥20% increase in tumor burden and minimum 5 mm absolute increase in compared to nadir; for no new non-target or (irNN) and where irPR or irPD are confirmed by a repeat, consecutive assessment no less than 4 weeks later.
Time frame: Up to 60 months
Overall Rates of Response (ORR)
ORR is defined as the number of subjects with complete response + partial response based on RECIST 1.1 and irRC criteria. RECIST 1.1 Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>=30% decrease in the sum of the longest diameter (LD) of target lesions. irRC Complete Response (irCR): Disappearance of all lesions, no new lesions, lymph nodes \< 10 mm in short axis, Partial Response (irPR): ≥30% decrease in the sum of target lesions and non-target lesions are irNN.
Time frame: 6 months
Rates of Response in Arm A and Arm B
Rates of Response is defined percent tumor size reduction based RECIST1.1 and irRC criteria (the latter if applicable) after each component of therapy in Arm A and Arm B.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Toxicity Profile
The toxicity profile is classified and defined by both provider and the participants reported outcomes. Clinician assessed toxicity will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) Participants assessed toxicity will be classified based on the Patient-Reported Outcome version of the CTCAE (PRO-CTCAE). Adverse events occurring in greater than two patients or any grade 3 toxicity were included.
Time frame: 6 months
Quality of Life (QOL) End of Treatment
Changes in QOL score for each subject are defined as the difference between the baseline, and at end of treatment. QOL will be evaluated using The Functional Assessment of Cancer Therapy-Lung (FACT-Lung) scale at baseline and the end of treatment. The FACT-L is the FACT-G and a lung cancer-specific (LCS) subscale given at baseline and end of treatment. The FACT-G is a 27-item measure of general QOL assessing function in 4 domains: physical well-being, social-family well-being, emotional well-being, and functional well-being. Items are rated by patients on a Likert scale from 0 to 4. Higher scores represent better QOL.
Time frame: Baseline to End of Treatment (up to 210 Days)
Quality of Life (QOL) 7 Weeks
Changes in QOL score for each subject are defined as the difference between the baseline, and at 7 weeks. QOL will be evaluated using The Functional Assessment of Cancer Therapy-Lung (FACT-Lung) scale at baseline and 7 weeks. The FACT-L is the FACT-G and a lung cancer-specific (LCS) subscale given at baseline and at end of treatment. The FACT-G is a 27-item measure of general QOL assessing function in 4 domains: physical well-being, social-family well-being, emotional well-being, and functional well-being. Items are rated by patients on a Likert scale from 0 to 4. Higher scores represent better QOL.
Time frame: Baseline to 7 weeks (40-50 Days)