Nonsmall Cell Lung CancerPhase 2NCT04253964
Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy
A Phase 2 study testing Pembrolizumab, Atezolizumab and Cemiplimab-Rwlc in people with Nonsmall Cell Lung Cancer and Performance Status, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonsmall Cell Lung Cancer, Performance Status
- What is being tested?
- Pembrolizumab, Atezolizumab and Cemiplimab-Rwlc
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2020to 1 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 normal organ and marrow function as defined below:
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- 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.
Who cannot join
- 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). For non-squamous subtypes, molecular testing of tumor and peripheral blood should be attempted for actionable biomarkers, but if there is an insufficient quantity of tumor material for testing and it is not feasible to attempt additional biopsies before starting systemic therapy, then these biomarker results are not necessary for inclusion on the study. For squamous subtype, molecular testing should be considered but is not necessary for inclusion on the study.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
Kathryn Mileham, MD, 980-442-3860, Kathryn.Mileham@advocatehealth.org
Thomas Lycan, D.O., M.H.S.
- Recruiting
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
Project Manager, 336-716-5772, Melani.Terry@advocatehealth.org
Thomas Lycan, Jr., D.O., M.H.S.
About this study
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
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.
Read the 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.
- Conditions
- Nonsmall Cell Lung Cancer, Performance Status
- Being tested
- Pembrolizumab, Atezolizumab, Cemiplimab-Rwlc, Carboplatin, Paclitaxel
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
ALL PARTICIPANTS: Pembrolizumab 200 mg intravenously (IV) on day 1 of each 3-week cycle for 4 cycles.
AtezolizumabDrug
ALL PARTICIPANTS: 1,200 mg IV on day 1 over 60 minutes of each 3-week cycle for 4 cycles. If the first infusion is tolerated, then all subsequent infusions (cycles 2-4) may be delivered over 30 minutes. The subcutaneous formulation of atezolizumab may be substituted for the intravenous formulation as follows: Atezolizumab hyaluronidase-tqjs 15 mL (1,875 mg atezolizumab and 30,000 units hyaluronidase) subcutaneously into the thigh over 7 minutes on day 1 of each 3-week cycle for 4 cycles.
Cemiplimab-RwlcDrug
ALL PARTICIPANTS: 350 mg IV over 30 minutes on day 1 of each 3-week cycle for 4 cycles.
CarboplatinDrug
FOR PARTICIPANTS IN EITHER ARM with non-squamous or squamous subtype, predictive biomarker PD-L1 ≥50%, and the treating clinician has opted for combination chemo/immunotherapy OR non-squamous or squamous subtype, predictive biomarker PD-L1 1-49% or unknown: Carboplatin area under the curve (AUC) 5 IV on day 1 of each 3-week cycle for 4 cycles. AUC dosing (5-6) will be selected by the treating provider.
PaclitaxelDrug
FOR PARTICIPANTS IN EITHER ARM with squamous subtype, predictive biomarker PD-L1 ≥50%, and the treating clinician has opted for combination chemo/immunotherapy OR squamous subtype, predictive biomarker PD-L1 1-49% or unknown: Paclitaxel 200 mg/m2 IV on day 1 of each 3-week cycle for 4 cycles.
Nab paclitaxelDrug
FOR PARTICIPANTS IN EITHER ARM with squamous subtype, predictive biomarker PD-L1 ≥50%, and the treating clinician has opted for combination chemo/immunotherapy OR squamous subtype, predictive biomarker PD-L1 1-49% or unknown: Nab-paclitaxel 100 mg/m2 on day 1, 8, 15 of 3-week cycle for 4 cycles.
PemetrexedDrug
FOR PARTICIPANTS IN EITHER ARM with non-squamous subtype, predictive biomarker PD-L1 ≥50%, and the treating clinician has opted for combination chemo/immunotherapy OR non-squamous subtype, predictive biomarker PD-L1 1-49% or unknown: Pemetrexed 500 mg/m2 IV on day 1 of each 3-week cycle for 4 cycles.
CisplatinDrug
FOR PARTICIPANTS IN EITHER ARM with non-squamous or squamous subtype, predictive biomarker PD-L1 ≥50%, and the treating clinician has opted for combination chemo/immunotherapy OR non-squamous or squamous subtype, predictive biomarker PD-L1 1-49% or unknown: Cisplatin 75 mg/m2 IV on day 1 of each 3-week cycle for 4 cycles.
Quality of Life Questionnaire, lung cancer-specific (QLQ-LC13)Other
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.
QLQ-C30 Global Health/Quality of Life QuestionnaireOther
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.
COPD Assessment Test and modified Medical Research Council Dyspnea Patient Reported OutcomesOther
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).
PROMIS and FACT-G QuestionnairesOther
PROMIS 4-item short forms: Fatigue, Sleep Disturbance, Anxiety, and Depression as well as 1 item from the FACT-G which has been established as a valid indicator of treatment side effect bother ("I am bothered by side effects of treatment"); 17 symptom burden questions in total.
Sleep Disorder Assessments (ISI, Berlin Sleep Questionnaire)Other
7 items on the Insomnia Severity Index (ISI) and 10 items from the Berlin Sleep Questionnaire, a risk assessment for obstructive sleep apnea.
| Study group | Role | What they receive |
|---|---|---|
| Performance Status 0-1 Participants | Experimental | Participants with non-squamous and squamous predictive biomarker PD-L1 ≥50%: Participants will receive one of the following if their treating physician has opted for single-agent immunotherapy: pembrolizumab, atezolizumab, or cemiplimab-rwlc.
Participants with non-squamous and squamous subtype, predictive biomarker PD-L1 ≥50%, and the treating clinician has opted for combination chemo/immunotherapy OR participants with non-squamous and squamous subtype, predictive biomarker PD-L1 1-49% or unknown: Participants will receive one of the following--pembrolizumab, atezolizumab, or cemiplimab-rwlc--and ALSO receive:
* Carboplatin OR
* Cisplatin
PLUS
* Pemetrexed (non-squamous subtype only) OR
* Paclitaxel (squamous subtype only) OR
* Nab-paclitaxel (squamous subtype only) Receives: Drug: Pembrolizumab; Drug: Atezolizumab; Drug: Cemiplimab-Rwlc; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab paclitaxel; Drug: Pemetrexed; Drug: Cisplatin; 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; Other: PROMIS and FACT-G Questionnaires; Other: Sleep Disorder Assessments (ISI, Berlin Sleep Questionnaire) |
| Performance Status 2 Participants | Experimental | Participants with non-squamous and squamous predictive biomarker PD-L1 ≥50%: Participants will receive one of the following if their treating physician has opted for single-agent immunotherapy: pembrolizumab, atezolizumab, or cemiplimab-rwlc.
Participants with non-squamous and squamous subtype, predictive biomarker PD-L1 ≥50%, and the treating clinician has opted for combination chemo/immunotherapy OR participants with non-squamous and squamous subtype, predictive biomarker PD-L1 1-49% or unknown: Participants will receive one of the following--pembrolizumab, atezolizumab, or cemiplimab-rwlc--and ALSO receive:
* Carboplatin OR
* Cisplatin
PLUS
* Pemetrexed (non-squamous subtype only) OR
* Paclitaxel (squamous subtype only) OR
* Nab-paclitaxel (squamous subtype only) Receives: Drug: Pembrolizumab; Drug: Atezolizumab; Drug: Cemiplimab-Rwlc; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab paclitaxel; Drug: Pemetrexed; Drug: Cisplatin; 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; Other: PROMIS and FACT-G Questionnaires; Other: Sleep Disorder Assessments (ISI, Berlin Sleep Questionnaire) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
RECIST v 1.1 criteria:
- Complete Response (CR): Disappearance of all target lesions.
- Partial Response (PR): Decrease by ≥ 30% in sum of longest diameter of target lesions.
- Stable Disease (SD): Not meeting criteria for CR, PR, or PD.
- Progressive Disease (PD): Increase by ≥ 20% in sum of longest diameter of target lesions or the appearance of one or more new lesions.
Participants that did not have radiographically measurable metastatic disease by RECIST criteria before starting treatment, progression is defined as the development of new lesions or by unequivocal progression of existing non-target lesions.
Measured: From baseline to end of 4th cycle of treatment (12 weeks)
Secondary outcomes (3)
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).
Measured: 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.
Measured: From baseline to end of 4th cycle of treatment (12 weeks)
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)
Measured: From baseline to end of 4th cycle of treatment (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Jul 2020
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonsmall Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Thomas Lycan, Jr., D.O., M.H.S., Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253964
- Sponsor's protocol ID
- IRB00063540
- Other IDs
- WFBCCC 62619, P30CA012197
- Status last verified
- Sep 2026
- First submitted
- 31 Jan 2020
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04253964
- Acronym / sponsor ID
- IRB00063540
- Conditions
- Nonsmall Cell Lung Cancer, Performance Status
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Performance Status 0-1 Participants | Experimental | Drug: Pembrolizumab, Drug: Atezolizumab, Drug: Cemiplimab-Rwlc, Drug: Carboplatin, Drug: Paclitaxel, Drug: Nab paclitaxel, Drug: Pemetrexed, Drug: Cisplatin, 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, Other: PROMIS and FACT-G Questionnaires, Other: Sleep Disorder Assessments (ISI, Berlin Sleep Questionnaire)Participants with non-squamous and squamous predictive biomarker PD-L1 ≥50%: Participants will receive one of the following if their treating physician has opted for single-agent immunotherapy: pembrolizumab, atezolizumab, or cemiplimab-rwlc. Participants with non-squamous and squamous subtype, predictive biomarker PD-L1 ≥50%, and the treating clinician has opted for combination chemo/immunotherapy OR participants with non-squamous and squamous subtype, predictive biomarker PD-L1 1-49% or unknown: Participants will receive one of the following--pembrolizumab, atezolizumab, or cemiplimab-rwlc--and ALSO receive: * Carboplatin OR * Cisplatin PLUS * Pemetrexed (non-squamous subtype only) OR * Paclitaxel (squamous subtype only) OR * Nab-paclitaxel (squamous subtype only) |
| Performance Status 2 Participants | Experimental | Drug: Pembrolizumab, Drug: Atezolizumab, Drug: Cemiplimab-Rwlc, Drug: Carboplatin, Drug: Paclitaxel, Drug: Nab paclitaxel, Drug: Pemetrexed, Drug: Cisplatin, 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, Other: PROMIS and FACT-G Questionnaires, Other: Sleep Disorder Assessments (ISI, Berlin Sleep Questionnaire)Participants with non-squamous and squamous predictive biomarker PD-L1 ≥50%: Participants will receive one of the following if their treating physician has opted for single-agent immunotherapy: pembrolizumab, atezolizumab, or cemiplimab-rwlc. Participants with non-squamous and squamous subtype, predictive biomarker PD-L1 ≥50%, and the treating clinician has opted for combination chemo/immunotherapy OR participants with non-squamous and squamous subtype, predictive biomarker PD-L1 1-49% or unknown: Participants will receive one of the following--pembrolizumab, atezolizumab, or cemiplimab-rwlc--and ALSO receive: * Carboplatin OR * Cisplatin PLUS * Pemetrexed (non-squamous subtype only) OR * Paclitaxel (squamous subtype only) OR * Nab-paclitaxel (squamous subtype only) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (5 listed)
- 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). For non-squamous subtypes, molecular testing of tumor and peripheral blood should be attempted for actionable biomarkers, but if there is an insufficient quantity of tumor material for testing and it is not feasible to attempt additional biopsies before starting systemic therapy, then these biomarker results are not necessary for inclusion on the study. For squamous subtype, molecular testing should be considered but is not necessary for inclusion on the study.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabALL PARTICIPANTS: Pembrolizumab 200 mg intravenously (IV) on day 1 of each 3-week cycle for 4 cycles. | Drug | Performance Status 0-1 Participants, Performance Status 2 Participants |
| AtezolizumabALL PARTICIPANTS: 1,200 mg IV on day 1 over 60 minutes of each 3-week cycle for 4 cycles. If the first infusion is tolerated, then all subsequent infusions (cycles 2-4) may be delivered over 30 minutes. The subcutaneous formulation of atezolizumab may be substituted for the intravenous formulation as follows: Atezolizumab hyaluronidase-tqjs 15 mL (1,875 mg atezolizumab and 30,000 units hyaluronidase) subcutaneously into the thigh over 7 minutes on day 1 of each 3-week cycle for 4 cycles. | Drug | Performance Status 0-1 Participants, Performance Status 2 Participants |
| Cemiplimab-RwlcALL PARTICIPANTS: 350 mg IV over 30 minutes on day 1 of each 3-week cycle for 4 cycles. | Drug | Performance Status 0-1 Participants, Performance Status 2 Participants |
| CarboplatinFOR PARTICIPANTS IN EITHER ARM with non-squamous or squamous subtype, predictive biomarker PD-L1 ≥50%, and the treating clinician has opted for combination chemo/immunotherapy OR non-squamous or squamous subtype, predictive biomarker PD-L1 1-49% or unknown: Carboplatin area under the curve (AUC) 5 IV on day 1 of each 3-week cycle for 4 cycles. AUC dosing (5-6) will be selected by the treating provider. | Drug | Performance Status 0-1 Participants, Performance Status 2 Participants |
| PaclitaxelFOR PARTICIPANTS IN EITHER ARM with squamous subtype, predictive biomarker PD-L1 ≥50%, and the treating clinician has opted for combination chemo/immunotherapy OR squamous subtype, predictive biomarker PD-L1 1-49% or unknown: Paclitaxel 200 mg/m2 IV on day 1 of each 3-week cycle for 4 cycles. | Drug | Performance Status 0-1 Participants, Performance Status 2 Participants |
| Nab paclitaxelFOR PARTICIPANTS IN EITHER ARM with squamous subtype, predictive biomarker PD-L1 ≥50%, and the treating clinician has opted for combination chemo/immunotherapy OR squamous subtype, predictive biomarker PD-L1 1-49% or unknown: Nab-paclitaxel 100 mg/m2 on day 1, 8, 15 of 3-week cycle for 4 cycles. | Drug | Performance Status 0-1 Participants, Performance Status 2 Participants |
| PemetrexedFOR PARTICIPANTS IN EITHER ARM with non-squamous subtype, predictive biomarker PD-L1 ≥50%, and the treating clinician has opted for combination chemo/immunotherapy OR non-squamous subtype, predictive biomarker PD-L1 1-49% or unknown: Pemetrexed 500 mg/m2 IV on day 1 of each 3-week cycle for 4 cycles. | Drug | Performance Status 0-1 Participants, Performance Status 2 Participants |
| CisplatinFOR PARTICIPANTS IN EITHER ARM with non-squamous or squamous subtype, predictive biomarker PD-L1 ≥50%, and the treating clinician has opted for combination chemo/immunotherapy OR non-squamous or squamous subtype, predictive biomarker PD-L1 1-49% or unknown: Cisplatin 75 mg/m2 IV on day 1 of each 3-week cycle for 4 cycles. | Drug | Performance Status 0-1 Participants, Performance Status 2 Participants |
| 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 | Performance Status 0-1 Participants, Performance Status 2 Participants |
| QLQ-C30 Global Health/Quality of Life Questionnaire30 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 | Performance Status 0-1 Participants, Performance Status 2 Participants |
| COPD Assessment Test and modified Medical Research Council Dyspnea Patient Reported OutcomesDyspnea 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). | Other | Performance Status 0-1 Participants, Performance Status 2 Participants |
| PROMIS and FACT-G QuestionnairesPROMIS 4-item short forms: Fatigue, Sleep Disturbance, Anxiety, and Depression as well as 1 item from the FACT-G which has been established as a valid indicator of treatment side effect bother ("I am bothered by side effects of treatment"); 17 symptom burden questions in total. | Other | Performance Status 0-1 Participants, Performance Status 2 Participants |
| Sleep Disorder Assessments (ISI, Berlin Sleep Questionnaire)7 items on the Insomnia Severity Index (ISI) and 10 items from the Berlin Sleep Questionnaire, a risk assessment for obstructive sleep apnea. | Other | Performance Status 0-1 Participants, Performance Status 2 Participants |
Primary outcome
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. RECIST v 1.1 criteria: * Complete Response (CR): Disappearance of all target lesions. * Partial Response (PR): Decrease by ≥ 30% in sum of longest diameter of target lesions. * Stable Disease (SD): Not meeting criteria for CR, PR, or PD. * Progressive Disease (PD): Increase by ≥ 20% in sum of longest diameter of target lesions or the appearance of one or more new lesions. Participants that did not have radiographically measurable metastatic disease by RECIST criteria before starting treatment, progression is defined as the development of new lesions or by unequivocal progression of existing non-target lesions.
3 secondary outcomes
Incidences of Grade 3 to Grade 5 Treatment-Related Adverse Events
Time frame: 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)
Proportion of Participants with Deterioration in Symptoms - QLQ-LC13
Time frame: From baseline to end of 4th cycle of treatment (12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Lycan, Jr., D.O., M.H.S. principal investigator
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, Atezolizumab and Cemiplimab-Rwlc in people with Nonsmall Cell Lung Cancer and Performance Status, run by Wake Forest University Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Project Manager (336-716-5772, Melani.Terry@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with Progression-Free Survival (time frame: From baseline to end of 4th cycle of treatment (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.