Phase II Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-Small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Proportion of Participants with Progression-Free Survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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.
排除标准
- •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.
研究组 & 干预措施
Performance Status 0-1 Participants
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)
干预措施: Quality of Life Questionnaire, lung cancer-specific (QLQ-LC13) (Other)
Performance Status 0-1 Participants
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)
干预措施: QLQ-C30 Global Health/Quality of Life Questionnaire (Other)
Performance Status 0-1 Participants
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)
干预措施: COPD Assessment Test and modified Medical Research Council Dyspnea Patient Reported Outcomes (Other)
Performance Status 2 Participants
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)
干预措施: Quality of Life Questionnaire, lung cancer-specific (QLQ-LC13) (Other)
Performance Status 2 Participants
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)
干预措施: QLQ-C30 Global Health/Quality of Life Questionnaire (Other)
Performance Status 2 Participants
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)
干预措施: COPD Assessment Test and modified Medical Research Council Dyspnea Patient Reported Outcomes (Other)
Performance Status 0-1 Participants
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)
干预措施: PROMIS and FACT-G Questionnaires (Other)
Performance Status 0-1 Participants
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)
干预措施: Sleep Disorder Assessments (ISI, Berlin Sleep Questionnaire) (Other)
Performance Status 2 Participants
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)
干预措施: PROMIS and FACT-G Questionnaires (Other)
Performance Status 2 Participants
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)
干预措施: Sleep Disorder Assessments (ISI, Berlin Sleep Questionnaire) (Other)
Performance Status 2 Participants
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)
干预措施: Atezolizumab (Drug)
Performance Status 0-1 Participants
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)
干预措施: Atezolizumab (Drug)
Performance Status 2 Participants
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)
干预措施: Cisplatin (Drug)
Performance Status 2 Participants
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)
干预措施: Cemiplimab-Rwlc (Drug)
Performance Status 2 Participants
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)
干预措施: Nab paclitaxel (Drug)
Performance Status 0-1 Participants
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)
干预措施: Cemiplimab-Rwlc (Drug)
Performance Status 0-1 Participants
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)
干预措施: Cisplatin (Drug)
Performance Status 0-1 Participants
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)
干预措施: Nab paclitaxel (Drug)
Performance Status 2 Participants
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)
干预措施: Pembrolizumab (Drug)
Performance Status 2 Participants
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)
干预措施: Carboplatin (Drug)
Performance Status 0-1 Participants
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)
干预措施: Pembrolizumab (Drug)
Performance Status 0-1 Participants
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)
干预措施: Paclitaxel (Drug)
Performance Status 0-1 Participants
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)
干预措施: Carboplatin (Drug)
Performance Status 0-1 Participants
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)
干预措施: Pemetrexed (Drug)
Performance Status 2 Participants
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)
干预措施: Paclitaxel (Drug)
Performance Status 2 Participants
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)
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Proportion of Participants with Progression-Free Survival
时间窗: 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.
Proportion of Participants with Progression-Free Survival
时间窗: 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.
次要结局
- Change in Overall Quality of Life/Global Health Status - EORTC QLQ-C30(From baseline to end of 4th cycle of treatment (12 weeks))
- Proportion of Participants with Deterioration in Symptoms - QLQ-LC13(From baseline to end of 4th cycle of treatment (12 weeks))
- Incidences of Grade 3 to Grade 5 Treatment-Related Adverse Events(12 weeks)