Study to Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of Avelumab In Combination With Either Crizotinib Or PF-06463922 In Patients With NSCLC. (Javelin Lung 101)

• ClinicalTrials.gov Identifier: NCT02584634
• Recruitment Status: Terminated
• First Posted: October 22, 2015
• Results First Posted: February 9, 2022
• Last Update Posted: July 7, 2023
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: October 21, 2015
• First Posted Date: October 22, 2015
• Results First Submitted Date: January 13, 2022
• Results First Posted Date: February 9, 2022
• Last Update Posted Date: July 7, 2023
• Actual Study Start Date: December 18, 2015
• Actual Primary Completion Date: February 2, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 13, 2022)

• Number of Participants With Dose-limiting Toxicities (DLTs): Phase 1b [ Time Frame: First 2 cycles (1 cycle = 14 days) ]
  Any of the following adverse events (AEs) occurring during the primary DLT observation period that are attributable to one, the other, or both study drugs were classified as DLTs: Grade 4 (life-threatening) neutropenia if >7 days in duration; febrile neutropenia; Grade >=3 (severe or life threatening) neutropenic infection; Grade >=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia >7 days; Grade 4 anemia; any Grade >=3 toxicity, except for any of the following: transient (<=6 hours) Grade 3 (severe) flu like symptoms or fever; transient (<=24 hours) Grade 3 fatigue, local reactions, or headache that resolved to Grade <=1 (no AE or mild AE); Grade 3 nausea and/or vomiting, diarrhea or skin toxicity that resolved to Grade <=1 within 7 days; any Grade >=3 amylase or lipase abnormality; tumor flare phenomenon; single laboratory values out of normal range that were not related to treatment, did not have any clinical correlate, and resolve to Grade <=1 within 7 days.
• Percentage of Participants With Objective Response (OR): Phase 2 [ Time Frame: Screening, Day 1 of each cycle starting Cycle 3, up to end of treatment/withdrawal (maximum of 5 years) ]
  OR is defined as complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 from start date (the date of first dose of study treatment) until disease progression or death due to any cause. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. Per RECIST v1.1: CR is defined as the disappearance of all target or non-target lesions; any pathological lymph nodes (whether target or non target) must have reduction in short axis to <10 mm and all lymph nodes must be non-pathological in size (<10 mm short axis). PR is defined as a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
• Percentage of Participants With CR for Group B: Phase 2 [ Time Frame: Baseline up to 60 months ]
  Per RECIST v1.1: CR is defined as the disappearance of all target or non-target lesions; any pathological lymph nodes (whether target or non target) must have reduction in short axis to <10 mm and all lymph nodes must be non-pathological in size (<10 mm short axis).

Original Primary Outcome Measures (submitted: October 21, 2015)

• First two cycles dose limiting toxicities (DLTs) for Group A and Group B [ Time Frame: 28 days ]
• Confirmed Overall Response (OR) per RECIST v.1.1 for Group A [ Time Frame: Up to 60 months ]
  Complete response (CR) or Partial Response (PR) from start date (first dose of study treatment) until disease progression or death. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met.

Current Secondary Outcome Measures (submitted: June 21, 2023)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to 30 days after last dose of study treatment or the day before start day of new anti-cancer therapy (maximum of 5 years) ]
  TEAEs are those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period. Treatment-related AEs was any untoward medical occurrence attributed to study drug in a participant who received study drug. Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03: Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment; Grade 4 (Life-threatening) events caused participant to be in imminent danger of death; Grade 5 (Death) events=death related to an AE. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in participant hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
• Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 [ Time Frame: Screening up to end of treatment/withdrawal (maximum of 5 years) ]
  The laboratory results were graded according to the NCI CTCAE v4.03 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Shift tables were provided to examine the distribution of laboratory toxicities. The following parameters had met the criteria of CTCAE grade shift change from Grade <=2 at baseline to Grade 3 or 4 post baseline: anemia, lymphocyte count decreased, lymphocyte count decreased, neutrophil count decreased, white blood cell decreased, alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, cholesterol high, Creatine phosphokinase (CPK) increased, Gamma glutamyl transferase (GGT) increased, hypercalcemia, hyperglycemia, hypermagnesemia, hypertriglyceridemia, hypoalbuminemia, hyponatremia, lipase increased, serum amylase increased. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment.
• Number of Participants With Vital Signs Meeting Pre-defined Criteria [ Time Frame: Screening up to end of treatment/withdrawal (maximum of 5 years) ]
  Pre-defined criteria in vital signs: pulse rate <50 beats per minute, pulse rate >120 bpm, sitting diastolic blood pressure (DBP) increase and decrease in change from baseline of >= 20 millimeter of mercury (mmHg), sitting systolic blood pressure(SBP) < 90 mmHg, increase and decrease in change from baseline of >= 30mmHg. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment.
• Disease Control Rate (DCR) [ Time Frame: Screening, Day 1 of each cycle starting Cycle 3, up to end of treatment/withdrawal (maximum of 5 years) ]
  DC is defined as objective response (CR or PR) or stable disease (SD) per RECIST v.1.1 from the date of first dose of study treatment until disease progression or death due to any cause. The DCR is the proportion of patients with DC. Per RECIST v1.1: CR is defined as the disappearance of all target or non-target lesions; any pathological lymph nodes (whether target or non target) must have reduction in short axis to <10 mm. PR is defined as a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is defined as a >=20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions.
• Duration of Response (DR) [ Time Frame: Screening, Day 1 of each cycle starting Cycle 3, up to end of treatment/withdrawal (maximum of 5 years) ]
  DR: time from first documented occurrence of response (PR or CR) until date of first documented PD or death due to underlying cancer. Per RECIST 1.1: CR: disappearance of all non-nodal target lesions and of all non-target lesions; any pathological lymph nodes assigned as target lesions/non-target lesions have a reduction in short axis to <10 mm. PR: at least a >=30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters. PD: at least a >=20% increase in sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Appearance of new lesions. Participants with no PD and were still alive by 02 Feb 2020, were censored at last adequate tumor assessment. Kaplan-Meier method was used for DR analysis.
• Time to Tumor Response (TTR) [ Time Frame: Screening, Day 1 of each cycle starting Cycle 3, up to end of treatment/withdrawal (maximum of 5 years) ]
  TTR is defined, for participants with an objective response (CR or PR), as the time from the start date (the date of first dose of treatment) to the first documentation of objective response (CR or PR) which is subsequently confirmed. Per RECIST v1.1: CR: disappearance of all non-nodal target lesions and of all non-target lesions. In addition, any pathological lymph nodes assigned as target lesions/ non-target lesions must have a reduction in short axis to <10 mm. PR: at least a 30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters.
• Progression-free Survival (PFS) [ Time Frame: Screening, Day 1 of each cycle starting Cycle 3, up to end of treatment/withdrawal (maximum of 5 years) ]
  PFS is defined as the time from start date (the date of first dose of treatment) to the date of the first documentation of PD per RECIST v1.1 or death due to any cause, whichever occurs first. Per RECIST v1.1: PD: a >=20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
• Kaplan-Meier Estimates of Overall Survival (OS) [ Time Frame: Screening, Day 1 of each cycle starting Cycle 3, up to end of treatment/withdrawal (maximum of 5 years) ]
  OS is defined as the time from start date (the date of first dose of treatment) to the date of death due to any cause.
• Maximum Plasma Concentration (Cmax) of Crizotinib in The Presence of Avelumab [ Time Frame: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2 ]
  Cmax of crizotinib in the presence of avelumab was observed directly from data.
• Time to Cmax (Tmax) of Crizotinib in The Presence of Avelumab [ Time Frame: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2 ]
  Tmax of crizotinib in the presence of avelumab was observed directly from data as time of first occurrence.
• Area Under The Plasma Concentration-Time Curve During The Dosing Interval Time Course (AUCtau) of Crizotinib in The Presence of Avelumab [ Time Frame: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2 ]
  AUCtau of crizotinib in the presence of avelumab was calculated by Linear/Log trapezoidal method. Dose interval is defined as after single dose from time zero to the next dose (after single dose and at steady state).
• Apparent Plasma Clearance (CL/F) of Crizotinib in The Presence of Avelumab [ Time Frame: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2 ]
  Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
• Cmax of Crizotinib Metabolite PF-06260182 in The Presence of Avelumab [ Time Frame: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2 ]
  Cmax of crizotinib metabolite PF-06260182 in the presence of avelumab was observed directly from data.
• Tmax of Crizotinib Metabolite PF-06260182 in The Presence of Avelumab [ Time Frame: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2 ]
  Tmax of crizotinib metabolite PF-06260182 in the presence of avelumab was observed directly from data as time of first occurrence.
• AUCtau of Crizotinib Metabolite PF-06260182 in The Presence of Avelumab [ Time Frame: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2 ]
  AUCtau of crizotinib metabolite PF-06260182 in the presence of avelumab was calculated by Linear/Log trapezoidal method. Dose interval: single dose from time zero to the next dose (after single dose and at steady state).
• Metabolite to Parent Ratio for AUCtau (MRAUCtau) of PF-06260182 in The Presence of Avelumab [ Time Frame: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2 ]
  MRAUCtau of metabolite PF-06260182 in the presence of avelumab was calculated (MRAUCtau=Metabolite AUCtau/parent AUCtau). Parent=crizotinib, metabolite=PF-06260182
• Metabolite to Parent Ratio for Cmax (MRCmax) of PF-06260182 in The Presence of Avelumab [ Time Frame: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2 ]
  MRCmax of metabolite PF-06260182 in the presence of avelumab was calculated (MRCmax=Metabolite Cmax/parent Cmax). Parent=crizotinib, metabolite=PF-06260182
• Cmax of Lorlatinib in The Presence of Avelumab [ Time Frame: Pre-dose, 1, 2, 4, 6, 8, and 24 hours (prior to Day 2 lorlatinib dose) post dose on Day 1 of Cycle 2 ]
  Cmax of lorlatinib in the presence of avelumab was observed directly from data.
• Tmax of Lorlatinib in The Presence of Avelumab [ Time Frame: Pre-dose, 1, 2, 4, 6, 8, and 24 hours (prior to Day 2 lorlatinib dose) post dose on Day 1 of Cycle 2 ]
  Tmax of lorlatinib in the presence of avelumab was observed directly from data.
• AUCtau of Lorlatinib in The Presence of Avelumab [ Time Frame: Pre-dose, 1, 2, 4, 6, 8, and 24 hours (prior to Day 2 lorlatinib dose) post dose on Day 1 of Cycle 2 ]
  AUCtau of lorlatinib in the presence of avelumab was calculated by Linear/Log trapezoidal method. Dose interval: single dose from time zero to the next dose (after single dose and at steady state).
• Area Under The Plasma Concentration Time Curve From Time of Dosing to The Last Collection Time Point (AUClast) of Lorlatinib in The Presence of Avelumab [ Time Frame: Pre-dose, 1, 2, 4, 6, 8, and 24 hours (prior to Day 2 lorlatinib dose) post dose on Day 1 of Cycle 2 ]
  AUClast of lorlatinib in the presence of avelumab.
• CL/F of Lorlatinib in The Presence of Avelumab [ Time Frame: Pre-dose, 1, 2, 4, 6, 8, and 24 hours (prior to Day 2 lorlatinib dose) post dose on Day 1 of Cycle 2 ]
  Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
• Cmax of Avelumab in The Presence of Crizotinib (Group A) or Lorlatinib (Group B) After Single Dose of Avelumab [ Time Frame: Pre-dose, 1, and 168 hours post dose of avelumab on Cycle 1 Day 1. ]
  Cmax of avelumab in the presence of crizotinib was observed directly from the data in Group A. Cmax of avelumab in the presence of lorlatinib was observed directly from the data in Group B.
• Cmax of Avelumab in The Presence of Crizotinib (Group A) or Lorlatinib (Group B) After Multiple Doses of Avelumab [ Time Frame: Pre-dose, 1, and 168 hours post dose of avelumab on Cycle 2 Day 1 ]
  Cmax of avelumab in the presence of crizotinib was observed directly from the data in Group A. Cmax of avelumab in the presence of lorlatinib was observed directly from the data in Group B.
• Trough Serum Concentration (Ctrough) of Avelumab in The Presence of Crizotinib (Group A) Following Multiple Doses of Avelumab [ Time Frame: Pre-dose on Day 1 of Cycles 2-5, 11, 17, 23, 29, 35, and 47. ]
  Ctrough is defined as predose concentration following multiple doses. Ctrough of avelumab in the presence of crizotinib was observed directly from the data in Group A.
• Trough Serum Concentration (Ctrough) of Avelumab in The Presence of Lorlatinib (Group B) Following Multiple Doses of Avelumab [ Time Frame: Pre-dose on Day 1 of Cycles 2-5, 11, 17, 23, 29, 35, 41, and 47. ]
  Ctrough is defined as predose concentration following multiple doses. Ctrough of avelumab in the presence of lorlatinib was observed directly from the data in Group B.
• Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status [ Time Frame: Day 1 of Cycles 1-5, then every 12 weeks thereafter, end of treatment/withdrawal, and 30 days after last avelumab dose (up to a maximum of 5 years) ]
  ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. Baseline is defined as the last assessment on or prior to the date/time of the first dose of avelumab.
• Number of Participants With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression [ Time Frame: Baseline ]
  PD-L1 protein expression is determined by using Combined Positive Score (CPS), which is the percentage of viable tumor and tumor-infiltrated immune cells (restricted to lymphocytes and macrophages) within or directly associated with tumor cell strands showing partial or complete membrane staining using the SP263 antibody. Positive is defined as CPS>=1% and negative is defined as CPS <1%.
• Number of Participants With Positive Tumor Infiltrating CD8+ Lymphocytes [ Time Frame: Baseline ]
  Tumor infiltrating CD8+ lymphocytes is defined as the number of CD8+ cells per unit area and the percent of counted cells. Positive is defined as >=1% and negative is defined as <1%.

Original Secondary Outcome Measures (submitted: October 21, 2015)

• Disease Control (DC) [ Time Frame: Up to 60 months. ]
  DC is defined as Best Overall Response of CR, PR, or Stable Disease (SD). Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met.
• Confirmed Overall Response (Group B) [ Time Frame: Up to 60 months ]
  CR or PR from start date until disease progression or death. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met.
• Overall Survival [ Time Frame: Up to 60 months ]
  Time from start date to the date of death due to any cause.
• AUClast [ Time Frame: Avelumab: Day 8, Crizotinib & PF-06463922: 24 hours ]
  Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration (Clast)
• AUCtau [ Time Frame: Avelumab: Days 1 and 8, Crizotinib & PF-06463922: Day 1 ]
  Area under the plasma concentration time profile after single dose from time zero to the next dose
• Cmax [ Time Frame: Avelumab: Day 1, Crizotinib & PF-06463922: Day 1 ]
  Maximum observed plasma concentration
• Tmax [ Time Frame: Avelumab: Day 1, Crizotinib & PF-06463922: Day 1 ]
  Time for Cmax
• t½a [ Time Frame: Avelumab: Days 1 and 8, Crizotinib & PF-06463922: Day 1 ]
  Terminal half life
• Ctrough [ Time Frame: Avelumab: Day 1 pre-dose sample, Crizotinib & PF-06463922: Day 1 ]
  Predose concentration during multiple dosing
• CL/Fa [ Time Frame: Avelumab: Days 1 and 8, Crizotinib & PF-06463922: Day 1 ]
  Apparent clearance
• Vz/Fa [ Time Frame: Avelumab: Days 1 and 8, Crizotinib & PF-06463922: Day 1 ]
  Apparent volume of distribution
• MRAUCtau [ Time Frame: Avelumab: Days 1 and 8, Crizotinib & PF=06463922: Day 1 ]
  Metabolite to parent ratio for AUCtau
• MRCmax [ Time Frame: Avelumab: Day 1, Crizotinib & PF=06463922: Day 1 ]
  Metabolite to parent ratio for Cmax
• tumor tissue biomarkers [ Time Frame: baseline ]
  Tumor tissue biomarkers, including but not limited to, PD-L1 expression and tumor infiltrating CD8+ T cells by immunohistochemistry (IHC)
• Duration of Response (DR) [ Time Frame: Up to 60 months ]
  DR is defined, for patients with an objective response, as the time from first documentation of objective response (CR or PR) to the date of first documentation of objective progression of disease or death due to any cause.
• Time to Treatment Response (TTR) [ Time Frame: Up to 60 months ]
  TTR is defined, for patients with an objective response, as the time from the start date to the first documentation of objective response (CR or PR) which is subsequently confirmed.
• Progression Free Survival (PFS) [ Time Frame: Up to 60 months ]
  PFS is defined as the time from start date to the date of the first documentation of PD or death due to any cause, whichever occurs first.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of Avelumab In Combination With Either Crizotinib Or PF-06463922 In Patients With NSCLC. (Javelin Lung 101)
• Official Title: A PHASE 1B/2, OPEN-LABEL, DOSE-FINDING STUDY TO EVALUATE SAFETY, EFFICACY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AVELUMAB (MSB0010718C) IN COMBINATION WITH EITHER CRIZOTINIB OR PF-06463922 IN PATIENTS WITH ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER
• Brief Summary: The purpose of this study is to evaluate the safety and efficacy of avelumab when combined with either crizotinib or PF-06463922.
• Detailed Description: This is a Phase 1b/2, open label, multi center, multiple dose, safety, pharmacokinetic and pharmacodynamic study of Group A and Group B in cohorts of adult patients with locally advanced or metastatic NSCLC.
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non-Small Cell Lung Cancer

Intervention

• Drug: Avelumab
  Administered by IV once every two weeks in doses of either 5 mg/kg or 10 mg/kg
  Other Name: MSB0010718C
• Drug: PF-06463922
  Tablets taken orally once every day in doses of either 100mg, 75mg, or 50mg.
• Drug: Crizotinib
  Capsules. Taken orally once or twice every day in doses of either 200mg or 250mg.
  Other Name: PF-02341066

Study Arms

• Experimental: Group A
  ALK negative Non-Small Cell Lung Cancer
  Interventions:

  • Drug: Avelumab
  • Drug: Crizotinib
• Experimental: Group B
  ALK positive Non-Small Cell Lung Cancer
  Interventions:

  • Drug: Avelumab
  • Drug: PF-06463922

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: January 14, 2020): 43
• Original Estimated Enrollment (submitted: October 21, 2015): 130
• Actual Study Completion Date: July 13, 2022
• Actual Primary Completion Date: February 2, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

• Inclusion Criteria
• Diagnosis of advanced or metastatic NSCLC. Group A must be ALK negative NSCLC and Group B must be ALK positive NSCLC
• Group A at least one prior regimen of therapy
• Group B any number of prior regimens.
• Mandatory tumor tissue available
• At least one measurable lesion
• ECOG Performance status 0 or 1
• Adequate bone marrow, renal, liver and pancreatic function
• Negative pregnancy test for females of childbearing potential
• Group B Phase 2: No prior systemic treatment for advanced or metastatic disease (adjuvant and/or neoadjuvant therapies are allowed if completed at least 6 months prior to study entry. No prior tyrosine kinase inhibitor therapy is allowed at any time prior to study entry)

Exclusion Criteria:

• No prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody.
• No Severe or Chronic medical conditions including gastrointestinal abnormalities or significant cardiac history
• No active infection requiring systemic therapy
• Prior organ transplantation including allogenic stem cell transplantation.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Japan, Korea, Republic of, Spain, United States
• Removed Location Countries: France

Administrative Information

• NCT Number: NCT02584634
• Other Study ID Numbers: B9991005; 2015-001879-43 ( EudraCT Number ); JAVELIN LUNG 101 ( Other Identifier: Alias Study Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Current Responsible Party: Pfizer
• Original Responsible Party: Same as current
• Current Study Sponsor: Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: June 2023