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Sitravatinib Plus Pembrolizumab in Patients With Advanced Treatment-Naïve PD-L1+ Non-Squamous NSCLC

Primary Purpose

Carcinoma, Non-Small-Cell Lung, Lung Diseases, Lung Neoplasms

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sitravatinib
Pembrolizumab
Sponsored by
Sarah Goldberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Inclusion Criteria:

In order to be to be eligible to participate in this study, an individual must meet all of the following criteria:

  • Histologically or cytologically confirmed non-squamous NSCLC that is metastatic (Stage IV), recurrent, or unresectable locally advanced (Stage IIIB/IIIC) disease, not amenable to treatment with curative intent.
  • No prior systemic therapy for advanced disease. Prior chemotherapy for local or locally advanced disease is allowed if completed >6 months prior to trial enrollment. Prior immunotherapy is not allowed.
  • PD-L1 ≥ 1% using the 22c3 PD-L1 IHC assay or a local assay performed in a CLIA facility
  • Age ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Life expectancy of at least 3 months.
  • Measurable disease as per RECIST v1.1
  • Adequate bone marrow and organ function demonstrated by:

    • Absolute neutrophil count >1,500/mm3 (1.5 × 10^9/L).
    • Hemoglobin ≥ 8.0 g/dL not dependent on transfusion support.
    • Platelet count ≥ 75 × 10^9/L (≥ 75,000 per mm3).
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN without liver metastases; < 5.0 x ULN if documented liver metastases
    • Serum total bilirubin ≤ ULN, or for patients with potential Gilbert's, direct bilirubin ≤ ULN
    • Calculated creatinine clearance ≥ 40 mL/min, using the Cockcroft-Gault formula.
  • Women of child-bearing potential (WOCBP) or men whose partner is a WOCBP agrees to use contraception while participating in this study, and for a period of 6 months following termination of study treatment.
  • Completed informed consent process, including signing IRB approved informed consent form.
  • Willing to comply with clinical trial instructions and requirements.
  • Willing to undergo an on-treatment biopsy with an appropriate biopsy site identified prior to treatment initiation

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  • Symptomatic or untreated brain metastases ≥ 2cm in diameter. Patients with brain lesions that are adequately treated with local therapy (i.e. radiation therapy) and neurologically stable without the need for corticosteroids for at least 2 weeks prior to enrollment are allowed. Patients with brain lesions that are asymptomatic, smaller than 2cm, in non-critical regions of the brain and not requiring corticosteroids for at least 2 weeks prior to enrollment may be eligible after review with the Sponsor Investigator.
  • Leptomeningeal disease
  • Known mutations/alterations in EGFR, ROS1, ALK, or BRAF
  • Any prior treatment with checkpoint inhibitor therapy or other immunotherapy agents
  • Any prior treatment with therapy having the same mechanism of action as sitravatinib (e.g., tyrosine kinase inhibitor with a similar target profile or bevacizumab/ramucirumab)
  • Active or prior documented autoimmune disease within the past 2 years (note: patients with type 1 diabetes, vitiligo, Graves' disease, hypothyroidism due to an autoimmune condition only requiring hormone replacement, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded).
  • Active or prior immunocompromising conditions, including use of immunosuppressive medication within 2 weeks of enrollment. This does not include topical, intranasal or inhaled steroids with minimal systemic absorption or systemic corticosteroids at physiologic doses not to exceed 10mg/day of prednisone or equivalent. Use of higher dose corticosteroids for short/defined course (ie prophylaxis in patients with contrast dye allergy) is also allowed if indicated.
  • Uncontrolled HIV. Patients with HIV may be eligible if they meet the following criteria:

    • CD4+ T cell count>350 cell/uL
    • No history of AIDS-defining opportunistic infection within the past 12 months
    • Currently tolerating treatment with ART for at least 4 weeks prior to enrollment, with HIV viral load <400 copies/mL
    • Patients on specific ART drugs with possibility for drug-drug interaction with sitravatinib may be excluded (see appendix 5).
  • Active hepatitis C (HCV) infection. Patients with a history of HCV may be eligible if they have completed curative antiviral treatment with undetectable HCV viral load and liver function tests are otherwise within acceptable limits (as described in Section 4.5.2). Patients with chronic Hepatitis B (HBV) infection are not excluded if liver function is within acceptable limits, but should be evaluated for reactivation risk and started on suppressive antiviral therapy prior to enrollment if appropriate.
  • History of stroke or transient ischemic attack within the previous 6 months.
  • History of life threatening venous thromboembolic event (such as hemodynamically significant pulmonary embolism) or any arterial thrombotic event within the previous 6 months. Patients with non-life threatening venous thromboembolic events are not excluded and should be managed with anti-coagulation as per standard institutional practice.
  • Any of the following cardiac abnormalities:

    • Unstable angina pectoris within the past 6 months.
    • Congestive heart failure ≥ NYHA Class 3 within the past 6 months.
    • Prolonged QTc on electrocardiogram >500 milliseconds.
    • Left ventricular ejection fraction (LVEF) < 40%.
  • Uncontrolled hypertension (>150mm Hg or >100mm Hg diastolic) on multiple observations despite standard of care treatment
  • Major surgery within 4 weeks of the date of randomization.
  • History of significant hemoptysis or hemorrhage within 4 weeks of the date of randomization.
  • Known or suspected presence of another malignancy that could be mistaken for the malignancy under study during disease assessments.
  • Has received a live vaccine within 30 days prior to the first dose of trial treatment.
  • Pregnancy. WOCBP must have a negative serum or urine pregnancy test documented within the screening period prior to the date of randomization.
  • Breast-feeding or planning to breast-feed during the study or within 30 days following the last dose of sitravatinib and within 5 months following the last dose of pembrolizumab.
  • Any serious illness, uncontrolled inter-current illness, psychiatric illness, active or uncontrolled infection, or other medical history, including laboratory results, which, in the Investigator's opinion, would be likely to interfere with the patient's participation in the study, or with the interpretation of the results.

Sites / Locations

  • Yale University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1A: PD-L1 1-49%, Main Study Population

Group 1B: PD-L1 1-49%, Pembrolizumab run-in population

Group 2A: PD-L1 ≥ 50%, Main Study Population

Group 2B: PD-L1 ≥ 50%, Pembrolizumab run-in population

Arm Description

Participants with PD-L1 Tumor Proportion Score (TPS) 1-49% receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).

Participants with PD-L1 Tumor Proportion Score (TPS) 1-49% receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.

Participants with PD-L1 Tumor Proportion Score (TPS) ≥ 50% receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).

Participants with PD-L1 Tumor Proportion Score (TPS) ≥ 50% receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)
(1) Objective Response Rate (ORR): The primary endpoint for this study will be ORR as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in the main study population.

Secondary Outcome Measures

Overall Survival (OS)
Overall Survival (OS) in the main study populations (ie groups 1A and 2A) is a secondary endpoint for this study. OS in groups 1B and 2B is an exploratory endpoint.
Progression Free Survival (PFS)
Progression Free Survival (PFS) in the main study populations (ie groups 1A and 2A) is a secondary endpoint for this study. PFS in groups 1B and 2B is an exploratory endpoint.
Duration of Response (DOR)
Duration of Response (DOR) for patients in Group A is a secondary endpoints for this study; DOR for Group B is an exploratory endpoint.
Clinical Benefit Rate (CBR)
Clinical Benefit Rate (CBR) in Group A is a secondary endpoints for this study, while CBR in Group B is an exploratory endpoint.
Incidence of Adverse Events as per CTCAE v.5
Evaluation of the safety and toxicity profile of the combination of sitravatinib and pembrolizumab in the first-line treatment of patients with non-squamous metastatic NSCLC is a secondary objective in this study. Secondary endpoint is adverse events as per CTCAE v.5. The Safety population is defined as all patients who received any dose of study treatment (i.e., sitravatinib and/or pembrolizumab) and will be used for all safety analyses.

Full Information

First Posted
June 8, 2021
Last Updated
June 20, 2023
Sponsor
Sarah Goldberg
Collaborators
Mirati Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04925986
Brief Title
Sitravatinib Plus Pembrolizumab in Patients With Advanced Treatment-Naïve PD-L1+ Non-Squamous NSCLC
Official Title
Phase 2 Trial of Sitravatinib Plus Pembrolizumab in Patients With Advanced Treatment-Naïve PD-L1+ Non-Squamous Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 10, 2022 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sarah Goldberg
Collaborators
Mirati Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a multicohort phase 2 study to evaluate the efficacy of pembrolizumab combined with the investigational drug sitravatinib in the frontline treatment of advanced, non-squamous PD-L1 positive NSCLC.
Detailed Description
This is a multicohort phase 2 study to evaluate the efficacy of pembrolizumab combined with the investigational drug sitravatinib in the frontline treatment of advanced, non-squamous PD-L1 positive NSCLC. For clinical analysis, there will be two patient cohorts defined by PD-L1 status: Cohort 1 for patients with PD-L1 Tumor Proportion Score (TPS) 1-49% and Cohort 2 for patients with TPS≥50%. The investigators will implement a Simon's two-stage design to evaluate the efficacy of sitravatinib in combination with pembrolizumab for each cohort separately. There will be two groups within each cohort of this study: the "main study population" (Group A) in which patients will receive pembrolizumab plus sitravatinib beginning on Cycle 1 Day 1 (C1D1), and a "pembrolizumab run-in population" (Group B) in which patients will receive pembrolizumab alone for 1 dose followed by pembrolizumab plus sitravatinib beginning C2D1. The primary endpoint of the trial is the ORR for patients treated with pembrolizumab plus sitravatinib in the main study population. The purpose of the pembrolizumab run-in population is to obtain tissue and blood samples from these patients to be used as controls for correlative studies and to determine the preliminary efficacy of pembrolizumab alone followed by the combination. Primary Objective (1) The primary objective of this study is to evaluate the efficacy of sitravatinib in combination with pembrolizumab in the front-line treatment of patients with advanced non-squamous PD-L1 positive NSCLC by measuring Objective Response Rate (ORR). Secondary Objectives To evaluate other measures of efficacy including Overall Survival (OS), Progression Free Survival (PFS), Duration of Response (DOR) and Clinical Benefit Rate (CBR) in the first-line setting for patients with advanced, non-squamous, PD-L1 positive NSCLC treated with the combination of sitravatinib and pembrolizumab. To evaluate the toxicity profile and tolerability of sitravatinib/pembrolizumab in advanced, treatment naïve, non-squamous, PD-L1 positive NSCLC. Exploratory Objectives: To evaluate ORR, OS, PFS, DOR, and CBR in patients with advanced, non-squamous, treatment naïve, PD-L1 positive NSCLC who receive pembrolizumab run-in followed by pembrolizumab/sitravatinib combination therapy. To evaluate the CNS activity of sitravatinib/pembrolizumab in patients with advanced, treatment naïve, PD-L1 positive NSCLC by measuring Intracranial Objective Response Rate (iORR) and Intracranial Duration of Response(iDOR) in patients with baseline CNS disease, and Intercranial Progression-Free Survival (iPFS) in all patients. To study correlates of the adaptive and innate immune responses induced by sitravatinib and pembrolizumab treatment in both tumor tissue and peripheral blood. To explore the association between tumor immune contexture and clinical benefit to sitravatinib and pembrolizumab.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung, Lung Diseases, Lung Neoplasms, Metastatic Lung Non-Small Cell Carcinoma, Stage IV Lung Non-Small Cell Cancer AJCC v7, PD-L1 Gene Mutation, Advanced Treatment-Naïve PD-L1, Sitravatinib, Pembrolizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1A: PD-L1 1-49%, Main Study Population
Arm Type
Experimental
Arm Description
Participants with PD-L1 Tumor Proportion Score (TPS) 1-49% receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
Arm Title
Group 1B: PD-L1 1-49%, Pembrolizumab run-in population
Arm Type
Experimental
Arm Description
Participants with PD-L1 Tumor Proportion Score (TPS) 1-49% receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.
Arm Title
Group 2A: PD-L1 ≥ 50%, Main Study Population
Arm Type
Experimental
Arm Description
Participants with PD-L1 Tumor Proportion Score (TPS) ≥ 50% receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
Arm Title
Group 2B: PD-L1 ≥ 50%, Pembrolizumab run-in population
Arm Type
Experimental
Arm Description
Participants with PD-L1 Tumor Proportion Score (TPS) ≥ 50% receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.
Intervention Type
Drug
Intervention Name(s)
Sitravatinib
Other Intervention Name(s)
IND 155305
Intervention Description
Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda
Intervention Description
All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
(1) Objective Response Rate (ORR): The primary endpoint for this study will be ORR as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in the main study population.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall Survival (OS) in the main study populations (ie groups 1A and 2A) is a secondary endpoint for this study. OS in groups 1B and 2B is an exploratory endpoint.
Time Frame
2 years
Title
Progression Free Survival (PFS)
Description
Progression Free Survival (PFS) in the main study populations (ie groups 1A and 2A) is a secondary endpoint for this study. PFS in groups 1B and 2B is an exploratory endpoint.
Time Frame
2 years
Title
Duration of Response (DOR)
Description
Duration of Response (DOR) for patients in Group A is a secondary endpoints for this study; DOR for Group B is an exploratory endpoint.
Time Frame
2 years
Title
Clinical Benefit Rate (CBR)
Description
Clinical Benefit Rate (CBR) in Group A is a secondary endpoints for this study, while CBR in Group B is an exploratory endpoint.
Time Frame
2 years
Title
Incidence of Adverse Events as per CTCAE v.5
Description
Evaluation of the safety and toxicity profile of the combination of sitravatinib and pembrolizumab in the first-line treatment of patients with non-squamous metastatic NSCLC is a secondary objective in this study. Secondary endpoint is adverse events as per CTCAE v.5. The Safety population is defined as all patients who received any dose of study treatment (i.e., sitravatinib and/or pembrolizumab) and will be used for all safety analyses.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: In order to be to be eligible to participate in this study, an individual must meet all of the following criteria: Histologically or cytologically confirmed non-squamous NSCLC that is metastatic (Stage IV), recurrent, or unresectable locally advanced (Stage IIIB/IIIC) disease, not amenable to treatment with curative intent. No prior systemic therapy for advanced disease. Prior chemotherapy for local or locally advanced disease is allowed if completed >6 months prior to trial enrollment. Prior immunotherapy is not allowed. PD-L1 ≥ 1% using the 22c3 PD-L1 IHC assay or a local assay performed in a CLIA facility Age ≥ 18 years. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Life expectancy of at least 3 months. Measurable disease as per RECIST v1.1 Adequate bone marrow and organ function demonstrated by: Absolute neutrophil count >1,500/mm3 (1.5 × 10^9/L). Hemoglobin ≥ 8.0 g/dL not dependent on transfusion support. Platelet count ≥ 75 × 10^9/L (≥ 75,000 per mm3). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN without liver metastases; < 5.0 x ULN if documented liver metastases Serum total bilirubin ≤ ULN, or for patients with potential Gilbert's, direct bilirubin ≤ ULN Calculated creatinine clearance ≥ 40 mL/min, using the Cockcroft-Gault formula. Women of child-bearing potential (WOCBP) or men whose partner is a WOCBP agrees to use contraception while participating in this study, and for a period of 6 months following termination of study treatment. Completed informed consent process, including signing IRB approved informed consent form. Willing to comply with clinical trial instructions and requirements. Willing to undergo an on-treatment biopsy with an appropriate biopsy site identified prior to treatment initiation Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: Symptomatic or untreated brain metastases ≥ 2cm in diameter. Patients with brain lesions that are adequately treated with local therapy (i.e. radiation therapy) and neurologically stable without the need for corticosteroids for at least 2 weeks prior to enrollment are allowed. Patients with brain lesions that are asymptomatic, smaller than 2cm, in non-critical regions of the brain and not requiring corticosteroids for at least 2 weeks prior to enrollment may be eligible after review with the Sponsor Investigator. Leptomeningeal disease Known mutations/alterations in EGFR, ROS1, ALK, or BRAF Any prior treatment with checkpoint inhibitor therapy or other immunotherapy agents Any prior treatment with therapy having the same mechanism of action as sitravatinib (e.g., tyrosine kinase inhibitor with a similar target profile or bevacizumab/ramucirumab) Active or prior documented autoimmune disease within the past 2 years (note: patients with type 1 diabetes, vitiligo, Graves' disease, hypothyroidism due to an autoimmune condition only requiring hormone replacement, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded). Active or prior immunocompromising conditions, including use of immunosuppressive medication within 2 weeks of enrollment. This does not include topical, intranasal or inhaled steroids with minimal systemic absorption or systemic corticosteroids at physiologic doses not to exceed 10mg/day of prednisone or equivalent. Use of higher dose corticosteroids for short/defined course (ie prophylaxis in patients with contrast dye allergy) is also allowed if indicated. Uncontrolled HIV. Patients with HIV may be eligible if they meet the following criteria: CD4+ T cell count>350 cell/uL No history of AIDS-defining opportunistic infection within the past 12 months Currently tolerating treatment with ART for at least 4 weeks prior to enrollment, with HIV viral load <400 copies/mL Patients on specific ART drugs with possibility for drug-drug interaction with sitravatinib may be excluded (see appendix 5). Active hepatitis C (HCV) infection. Patients with a history of HCV may be eligible if they have completed curative antiviral treatment with undetectable HCV viral load and liver function tests are otherwise within acceptable limits (as described in Section 4.5.2). Patients with chronic Hepatitis B (HBV) infection are not excluded if liver function is within acceptable limits, but should be evaluated for reactivation risk and started on suppressive antiviral therapy prior to enrollment if appropriate. History of stroke or transient ischemic attack within the previous 6 months. History of life threatening venous thromboembolic event (such as hemodynamically significant pulmonary embolism) or any arterial thrombotic event within the previous 6 months. Patients with non-life threatening venous thromboembolic events are not excluded and should be managed with anti-coagulation as per standard institutional practice. Any of the following cardiac abnormalities: Unstable angina pectoris within the past 6 months. Congestive heart failure ≥ NYHA Class 3 within the past 6 months. Prolonged QTc on electrocardiogram >500 milliseconds. Left ventricular ejection fraction (LVEF) < 40%. Uncontrolled hypertension (>150mm Hg or >100mm Hg diastolic) on multiple observations despite standard of care treatment Major surgery within 4 weeks of the date of randomization. History of significant hemoptysis or hemorrhage within 4 weeks of the date of randomization. Known or suspected presence of another malignancy that could be mistaken for the malignancy under study during disease assessments. Has received a live vaccine within 30 days prior to the first dose of trial treatment. Pregnancy. WOCBP must have a negative serum or urine pregnancy test documented within the screening period prior to the date of randomization. Breast-feeding or planning to breast-feed during the study or within 30 days following the last dose of sitravatinib and within 5 months following the last dose of pembrolizumab. Any serious illness, uncontrolled inter-current illness, psychiatric illness, active or uncontrolled infection, or other medical history, including laboratory results, which, in the Investigator's opinion, would be likely to interfere with the patient's participation in the study, or with the interpretation of the results.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Goldberg, MD MPH
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Sitravatinib Plus Pembrolizumab in Patients With Advanced Treatment-Naïve PD-L1+ Non-Squamous NSCLC

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