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ProtocolTrial Name and Objective
031507

Moving PD-1 Blockade with Pembrolizumab into Concurrent Chemoradiation for Locally Advanced Non-Small Cell Lung Cancer

1) To assess safety and toxicity of PD-1 inhibition with pembrolizumab with concurrent chemoradiation therapy for non-operable, locally advanced non-small cell lung cancer
2) To evaluate local control and distant metastasis-free survival, progression-free and overall survival with the addition of pembrolizumab to chemoradiotherapy
3) To evaluate the rates of pneumonitis that may result from combination pembrolizumab and chemoradiotherapy
4) To assess whether PD-L1 status on immunohistochemistry is predictive of response to pembrolizumab when combined with chemoradiation therapy
5)To assess T cell (CD8+T cells and CD4+FoxP3+ regulatory cells) responses at weeks 1, 3, 6 during chemoradiation therapy and before each administration of pembrolizumab for cycles 1, 2, 3
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031503

ALLIANCE A081105: Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC).

OBJECTIVES
2.1 Primary Objective
To assess whether adjuvant therapy with erlotinib will result in improved overall survival (OS) over placebo for patients with completely resected stage IB (?4 cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy.
2.2 Secondary Objectives
2.2.1 To assess whether adjuvant therapy with erlotinib will result in improved disease free survival (DFS) over placebo for patients with completely resected stage IB (?4 cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy, both overall and within the stage subgroups: IB and II/IIIA.
2.2.2 To evaluate the safety profile of erlotinib in the adjuvant setting.
2.2.3 To assess whether adjuvant therapy with erlotinib will result in improved DFS rate at 2 years, and OS rate at 5 years over placebo for patients with completely resected stage IB (? 4cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy, both overall and within the stage subgroups: IB and II/IIIA.
2.2.4 To assess the primary and secondary objectives in all randomized patients, regardless of central confirmation of the EGFR mutant status.
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031404

NRG ONCOLOGY (RTOG 1306): A RANDOMIZED PHASE II STUDY OF INDIVIDUALIZED COMBINED MODALITY THERAPY FOR STAGE III NON-SMALL CELL LUNG CANCER (NSCLC).

OBJECTIVES
Primary Objective:
To assess whether patients with unresectable local-regionally advanced NSCLC treated with targeted agents based on molecular characteristics have a longer progression-free survival than those treated with standard care therapy alone.
Secondary Objectives:
To evaluate response rate;
To assess toxicity;
To assess overall survival;
To correlate clinical outcomes with tumor molecular aberrations identified from deep sequencing of selected kinomes in patients from whom adequate baseline tissue is available.
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031501

A phase II trial of concurrent chemoradiation with consolidation Pembrolizumab (MK-3475) for the treatment of inoperable or unresectable stage III non-small cell lung cancer (NSCLC): LUN14-179

Primary Objective:
To determine if consolidation therapy with Pembrolizumab (MK-3475), following concurrent chemoradiation improves time to death or distant metastatic disease, depending on which occurs first, in patients with inoperable or unresectable stage IIIA or IIIB NSCLC. Distant metastasis is defined as anything that is outside of the radiation field.
Secondary Objectives:
h To determine if consolidation therapy with Pembrolizumab (MK-3475), following concurrent chemoradiation improves progression free survival (PFS) and overall survival (OS) in patients with inoperable or unresectable stage IIIA or IIIB NSCLC.
h To assess toxicity and tolerability of consolidation therapy with Pembrolizumab (MK-3475), following concurrent chemoradiation in patients with inoperable or unresectable stage IIIA or IIIB NSCLC.
h Time To Death in evaluable set
Exploratory Objectives:
To assess PD-L1 expression levels in the tumor samples of patients with inoperable or unresectable stage IIIA or IIIB NSCLC and correlate with time to distant metastatic disease, tumor histology, PFS, OS, and treatment toxicity
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031502

ECOG 4512: A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein.

Primary objective:
To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival (OS) over placebo for patients with stage IB ? 4cm, II and IIIA, ALK-positive NSCLC following surgical resection.

Secondary objectives:
1. To evaluate and compare disease-free survival (DFS) associated with crizotinib and placebo
2. To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting
3. To collect tumor tissue and blood specimens for future research.
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051506

CLDK378A2112: Phase I, multi-center, randomized open label study to assess the systemic exposure and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged (ALK-positive) metastatic non-small cell lung cancer (NSCLC.)

Primary Objective:
To assess the steady-state PK of 450 mg or 600 mg ceritinib taken daily
with a low-fat meal as compared with that of 750 mg ceritinib taken daily in
the fasted state in patients with metastatic ALK-positive NSCLC.

Secondary objective:
To assess the safety profile (including frequency of patients with GI AEs by
severity and overall) of 450 mg or 600 mg ceritinib taken daily with a lowfat
meal as compared with that of 750 mg ceritinib taken daily in the fasted
state in patients with metastatic ALK-positive NSCLC

To assess the single-dose PK of 450 mg or 600 mg ceritinib taken daily
with a low-fat meal as compared with that of 750 mg ceritinib taken daily in
the fasted state in patients with metastatic ALK-positive NSCLC

To assess the antitumor activity of ceritinib as measured by objective
response rate (ORR) and duration of response (DOR) in patients with
metastatic ALK-positive NSCLC following oral dosing of 450 mg or 600 mg
ceritinib taken daily with a low-fat meal as compared with that of 750 mg
ceritinib taken daily in the fasted state
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031504

ALLIANCE A151216: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST): A screening trial for A081105 and E4512.

2.0 OBJECTIVES
2.1 Primary Objectives
2.1.1 To centrally genotype resected lung adenocarcinomas for EGFR mutations and ALK
rearrangements to facilitate accrual to randomized adjuvant studies.
2.1.2 To obtain clinically annotated tumor tissue and patient-matched non-malignant DNA from
peripheral blood, as well as detailed epidemiologic and clinical follow-up data, to allow
clinically annotated advanced genomic analyses in concert with the NCI Center for Cancer
Genomics (CCG).
2.2 Secondary Objectives
2.2.1 To characterize the natural history of EGFR and ALK wild-type lung cancers to allow
subsequent development of targeted therapies against genotype-defined subpopulations in
the adjuvant and recurrent settings.
2.2.2 To cross-validate local genotyping assays for EGFR and ALK with a central reference
standard.
2.3 Exploratory/Other Objectives
2.3.1 To study the genomic evolution of lung cancers by comparing genomic characteristics at
resection and at recurrence.
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