Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors
NCT ID: NCT03037385
Last Updated: 2025-05-31
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE1/PHASE2
Total Enrollment
590 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-03-17
Study Completion Date
2024-03-21
Brief Summary
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This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of pralsetinib (BLU-667) administered orally in participants with medullary thyroid cancer (MTC), RET-altered NSCLC and other RET-altered solid tumors.
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Detailed Description
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The study consists of 2 parts, a dose-escalation part (Phase 1) and an expansion part (Phase 2). Both parts will enroll participants with advanced non-resectable NSCLC, advanced non-resectable thyroid cancer and other advanced solid tumors that have progressed following standard systemic therapy, have not adequately responded to standard systemic therapy, or the participants must be intolerant to or the Investigator has determined that treatment with standard therapy is not appropriate, or there must be no accepted standard therapy for their disease.
Conditions
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RET-altered Non Small Cell Lung Cancer
Medullary Thyroid Cancer
RET-altered Papillary Thyroid Cancer
RET-altered Colon Cancer
RET-altered Solid Tumors
Lung Neoplasm
Carcinoma, Non-Small-Cell Lung
Thyroid Diseases
Thyroid Neoplasm
Thyroid Cancer, Papillary
Carcinoma, Neuroendocrine
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Disease
Carcinoma, Bronchogenic
Bronchial Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasm
Head and Neck Neoplasms
Adenocarcinoma, Papillary
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasm
Digestive System Disease
Gastrointestinal Disease
Colonic Diseases
Intestinal Disease
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Phase 1 (Complete):
* Advanced MTC, NSCLC or other solid tumor
* 30-600mg (PO QD or BID)
Phase 2 (400mg QD):
* Group 1: RET fusion NSCLC previously treated with a platinum chemotherapy
* Group 2: RET fusion NSCLC not previously treated for metastatic disease
* Group 3: MTC previously treated with cabozantinib and/or vandetanib
* Group 4: MTC not previously treated with cabozantinib or vandetanib
* Group 5: Other solid tumors with a RET fusion not eligible for any of the other groups and previously treated with SOC or have no acceptable SOC for their tumor type as determined by the investigator
* Group 6: Any solid tumor with a RET alteration (fusion or mutation) previously treated with a selective RET Inhibitor
* Group 7: Other solid tumors with a RET mutation previously treated with SOC
* Group 8: RET fusion NSCLC previously treated with a platinum chemotherapy (China only)
* Group 9: MTC not previously treated with systemic therapy for advanced or metastatic disease (China only)
* Advanced MTC, NSCLC or other solid tumor
* 30-600mg (PO QD or BID)
Phase 2 (400mg QD):
* Group 1: RET fusion NSCLC previously treated with a platinum chemotherapy
* Group 2: RET fusion NSCLC not previously treated for metastatic disease
* Group 3: MTC previously treated with cabozantinib and/or vandetanib
* Group 4: MTC not previously treated with cabozantinib or vandetanib
* Group 5: Other solid tumors with a RET fusion not eligible for any of the other groups and previously treated with SOC or have no acceptable SOC for their tumor type as determined by the investigator
* Group 6: Any solid tumor with a RET alteration (fusion or mutation) previously treated with a selective RET Inhibitor
* Group 7: Other solid tumors with a RET mutation previously treated with SOC
* Group 8: RET fusion NSCLC previously treated with a platinum chemotherapy (China only)
* Group 9: MTC not previously treated with systemic therapy for advanced or metastatic disease (China only)
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Phase 1 Dose Escalation
Multiple doses of pralsetinib (BLU-667) for oral administration.
Group Type
EXPERIMENTAL
pralsetinib (BLU-667)
Intervention Type
DRUG
pralsetinib (BLU-667) is a potent and selective inhibitor of the RET mutations, fusions, and predicted resistant mutants
Phase 2 Dose Expansion
Oral dose of pralsetinib (BLU-667) as determined during Dose Escalation.
Group Type
EXPERIMENTAL
pralsetinib (BLU-667)
Intervention Type
DRUG
pralsetinib (BLU-667) is a potent and selective inhibitor of the RET mutations, fusions, and predicted resistant mutants
Interventions
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pralsetinib (BLU-667)
pralsetinib (BLU-667) is a potent and selective inhibitor of the RET mutations, fusions, and predicted resistant mutants
Intervention Type
DRUG
Other Intervention Names
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BLU-667
Eligibility Criteria
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Inclusion Criteria
* Diagnosis during dose escalation (Phase 1) - Pathologically documented, definitively diagnosed non-resectable advanced solid tumor.
* All participants treated at doses \> 120 mg per day must have MTC, or a RET-altered solid tumor per local assessment of tumor tissue and/or blood.
* Diagnosis during dose expansion (Phase 2) - All participants (with the exception of participants with MTC enrolled in Groups 3, 4, and 9) must have an oncogenic RET-rearrangement/fusion or mutation (excluding synonymous, frameshift, and nonsense mutations) solid tumor, as determined by local or central testing of tumor or circulating tumor nucleic acid in blood; as detailed below.
* Group 1 - participants must have pathologically documented, definitively diagnosed locally advanced or metastatic NSCLC with a RET fusion previously treated with a platinum-based chemotherapy.
* Group 2 - participants must have pathologically documented, definitively diagnosed locally advanced or metastatic NSCLC with a RET fusion not previously treated with a platinum-based chemotherapy, including those who have not had any systemic therapy. Prior platinum chemotherapy in the neoadjuvant and adjuvant setting is permitted if the last dose of platinum was 4 months or more before the first dose of study drug.
* Group 3 - participants must have pathologically documented, definitively diagnosed advanced MTC that had progressed within 14 months prior to the Screening Visit and was previously treated with cabozantinib and/or vandetanib.
* Group 4 - participants must have pathologically documented, definitively diagnosed advanced MTC that had progressed within 14 months prior to the Screening Visit and was not previously treated with cabozantinib and/or vandetanib.
* Group 5 - participants must have a pathologically documented, definitively diagnosed advanced solid tumor with an oncogenic RET fusion, have previously received standard of care (SOC) appropriate for their tumor type (unless there is no accepted standard therapy for the tumor type or the Investigator has determined that treatment with standard therapy is not appropriate), and must not have been eligible for any of the other groups.
* Group 6 - participants must have a pathologically documented, definitively diagnosed advanced solid tumor with an oncogenic RET fusion or mutation that was previously treated with a selective tyrosine kinase inhibitor (TKI) that inhibits RET
* Group 7 - participants must have a pathologically documented, definitively diagnosed advanced solid tumor with an oncogenic RET mutation previously treated with SOC appropriate for the tumor type and not eligible for any of the other groups
* Group 8 - participants must have pathologically documented, definitively diagnosed locally advanced or metastatic NSCLC with a RET fusion that was previously treated with a platinum based chemotherapy (China only).
* Group 9 - participants must have pathologically documented, definitively diagnosed advanced MTC that had progressed within 14 months prior to the Screening Visit, and was not previously treated with systemic therapy (except prior cytotoxic chemotherapy is allowed) for advanced or metastatic disease (China only).
* Participants must have non-resectable disease.
* Dose expansion (Phase 2): Participants in all groups (except Group 7) must have measurable disease per RECIST v1.1 (or RANO, criteria if appropriate for tumor type).
* Participants agrees to provide tumor tissue (archived, if available or a fresh biopsy) for RET status confirmation and is willing to consider an on-treatment tumor biopsy, if considered safe and medically feasible by the treating Investigator. For Phase 2, Group 6, participants are required to undergo a pretreatment biopsy to define baseline RET status in tumor tissue.
* Participants has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
* All participants treated at doses \> 120 mg per day must have MTC, or a RET-altered solid tumor per local assessment of tumor tissue and/or blood.
* Diagnosis during dose expansion (Phase 2) - All participants (with the exception of participants with MTC enrolled in Groups 3, 4, and 9) must have an oncogenic RET-rearrangement/fusion or mutation (excluding synonymous, frameshift, and nonsense mutations) solid tumor, as determined by local or central testing of tumor or circulating tumor nucleic acid in blood; as detailed below.
* Group 1 - participants must have pathologically documented, definitively diagnosed locally advanced or metastatic NSCLC with a RET fusion previously treated with a platinum-based chemotherapy.
* Group 2 - participants must have pathologically documented, definitively diagnosed locally advanced or metastatic NSCLC with a RET fusion not previously treated with a platinum-based chemotherapy, including those who have not had any systemic therapy. Prior platinum chemotherapy in the neoadjuvant and adjuvant setting is permitted if the last dose of platinum was 4 months or more before the first dose of study drug.
* Group 3 - participants must have pathologically documented, definitively diagnosed advanced MTC that had progressed within 14 months prior to the Screening Visit and was previously treated with cabozantinib and/or vandetanib.
* Group 4 - participants must have pathologically documented, definitively diagnosed advanced MTC that had progressed within 14 months prior to the Screening Visit and was not previously treated with cabozantinib and/or vandetanib.
* Group 5 - participants must have a pathologically documented, definitively diagnosed advanced solid tumor with an oncogenic RET fusion, have previously received standard of care (SOC) appropriate for their tumor type (unless there is no accepted standard therapy for the tumor type or the Investigator has determined that treatment with standard therapy is not appropriate), and must not have been eligible for any of the other groups.
* Group 6 - participants must have a pathologically documented, definitively diagnosed advanced solid tumor with an oncogenic RET fusion or mutation that was previously treated with a selective tyrosine kinase inhibitor (TKI) that inhibits RET
* Group 7 - participants must have a pathologically documented, definitively diagnosed advanced solid tumor with an oncogenic RET mutation previously treated with SOC appropriate for the tumor type and not eligible for any of the other groups
* Group 8 - participants must have pathologically documented, definitively diagnosed locally advanced or metastatic NSCLC with a RET fusion that was previously treated with a platinum based chemotherapy (China only).
* Group 9 - participants must have pathologically documented, definitively diagnosed advanced MTC that had progressed within 14 months prior to the Screening Visit, and was not previously treated with systemic therapy (except prior cytotoxic chemotherapy is allowed) for advanced or metastatic disease (China only).
* Participants must have non-resectable disease.
* Dose expansion (Phase 2): Participants in all groups (except Group 7) must have measurable disease per RECIST v1.1 (or RANO, criteria if appropriate for tumor type).
* Participants agrees to provide tumor tissue (archived, if available or a fresh biopsy) for RET status confirmation and is willing to consider an on-treatment tumor biopsy, if considered safe and medically feasible by the treating Investigator. For Phase 2, Group 6, participants are required to undergo a pretreatment biopsy to define baseline RET status in tumor tissue.
* Participants has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
Exclusion Criteria
* Participant's cancer has a known primary driver alteration other than RET. For example, NSCLC with a targetable mutation in EGFR, ALK, ROS1 or BRAF; colorectal with an oncogenic KRAS, NRAS, or BRAF mutation.
* Participants had any of the following within 14 days prior to the first dose of study drug:
1. Platelet count \< 75 × 10\^9/L.
2. Absolute neutrophil count \< 1.0 × 10\^9/L.
3. Hemoglobin \< 9.0 g/dL (red blood cell transfusion and erythropoietin may be used to reach at least 9.0 g/dL, but must have been administered at least 2 weeks prior to the first dose of study drug.
4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 × the upper limit of normal (ULN) if no hepatic metastases are present; \> 5 × ULN if hepatic metastases are present.
5. Total bilirubin \> 1.5 × ULN; \> 3 × ULN with direct bilirubin \> 1.5 × ULN in presence of Gilbert's disease.
6. Estimated (Cockcroft-Gault formula) or measured creatinine clearance \< 40 mL/min.
7. Total serum phosphorus \> 5.5 mg/dL
* QT interval corrected using Fridericia's formula (QTcF) \> 470 msec or history of prolonged QT syndrome or Torsades de pointes, or familial history of prolonged QT syndrome.
* Clinically significant, uncontrolled, cardiovascular disease.
* Central nervous system (CNS) metastases or a primary CNS tumor that is associated with progressive neurological symptoms.
* Clinically symptomatic interstitial lung disease or interstitial pneumonitis including radiation pneumonitis
* Participants in Groups 1-5 and 7 (Phase 2) previously treated with a selective RET inhibitor
* Participant had a major surgical procedure within 14 days of the first dose of study drug
* Participant had a history of another primary malignancy that had been diagnosed or required therapy within the a year prior to the study
* Pregnant or breastfeeding female participants
* Participants had any of the following within 14 days prior to the first dose of study drug:
1. Platelet count \< 75 × 10\^9/L.
2. Absolute neutrophil count \< 1.0 × 10\^9/L.
3. Hemoglobin \< 9.0 g/dL (red blood cell transfusion and erythropoietin may be used to reach at least 9.0 g/dL, but must have been administered at least 2 weeks prior to the first dose of study drug.
4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 × the upper limit of normal (ULN) if no hepatic metastases are present; \> 5 × ULN if hepatic metastases are present.
5. Total bilirubin \> 1.5 × ULN; \> 3 × ULN with direct bilirubin \> 1.5 × ULN in presence of Gilbert's disease.
6. Estimated (Cockcroft-Gault formula) or measured creatinine clearance \< 40 mL/min.
7. Total serum phosphorus \> 5.5 mg/dL
* QT interval corrected using Fridericia's formula (QTcF) \> 470 msec or history of prolonged QT syndrome or Torsades de pointes, or familial history of prolonged QT syndrome.
* Clinically significant, uncontrolled, cardiovascular disease.
* Central nervous system (CNS) metastases or a primary CNS tumor that is associated with progressive neurological symptoms.
* Clinically symptomatic interstitial lung disease or interstitial pneumonitis including radiation pneumonitis
* Participants in Groups 1-5 and 7 (Phase 2) previously treated with a selective RET inhibitor
* Participant had a major surgical procedure within 14 days of the first dose of study drug
* Participant had a history of another primary malignancy that had been diagnosed or required therapy within the a year prior to the study
* Pregnant or breastfeeding female participants
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Mayo Clinic Hospital
Phoenix, Arizona, United States
Site Status
UC Irvine Medical Center
Orange, California, United States
Site Status
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Site Status
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Site Status
Mayo Clinic-Jacksonville
Jacksonville, Florida, United States
Site Status
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Site Status
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States
Site Status
Massachusetts General Hospital.
Boston, Massachusetts, United States
Site Status
University of Michigan
Ann Arbor, Michigan, United States
Site Status
Mayo Clinic Rochester
Rochester, Minnesota, United States
Site Status
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
Site Status
Albany Medical Center
Albany, New York, United States
Site Status
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, United States
Site Status
Oregon Health & Science University
Portland, Oregon, United States
Site Status
Texas Oncology-Austin Midtown
Austin, Texas, United States
Site Status
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Site Status
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Site Status
Seattle Cancer Care Alliance
Seattle, Washington, United States
Site Status
Antwerp University Hospital
Edegem, , Belgium
Site Status
Beijing Cancer Hospital
Beijing, , China
Site Status
Beijing Cancer Hospital
Beijing, , China
Site Status
The affiliated Cancer Hospital, School of Medicine, UESTC
Chengdu, , China
Site Status
West China Hospital, Sichuan University
Chengdu, , China
Site Status
Chongqing Cancer Hospital
Chongqing, , China
Site Status
Fujian Provincial Cancer Hospital
Fuzhou, , China
Site Status
First Affiliated Hospital of Gannan Medical University
Ganzhou, , China
Site Status
Sun Yet-sen University Cancer Center
Guangzhou, , China
Site Status
Guangdong General Hospital
Guangzhou, , China
Site Status
Zhejiang Cancer Hospital
Hangzhou, , China
Site Status
Jinan Central Hospital
Jinan, , China
Site Status
Gansu Cancer Hospital
Lanzhou, , China
Site Status
Fudan University Shanghai Cancer Center
Shanghai, , China
Site Status
Fudan University Shanghai Cancer Center
Shanghai, , China
Site Status
Tianjin Medical University Cancer Institute & Hospital
Tianjing, , China
Site Status
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, , China
Site Status
Henan Cancer Hospital
Zhengzhou, , China
Site Status
Institut Bergonie
Bordeaux, , France
Site Status
Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
Lille, , France
Site Status
Centre Léon Bérard
Lyon, , France
Site Status
Centre Antoine Lacassagne
Nice, , France
Site Status
Institut Curie
Paris, , France
Site Status
CHU de Rennes - Hopital de Pontchaillo
Rennes, , France
Site Status
Hôpital Larrey
Toulouse, , France
Site Status
Gustave Roussy
Villejuif, , France
Site Status
Helios Klinikum Emil von Behring GmbH
Berlin, , Germany
Site Status
Universitätsklinikum Essen
Essen, , Germany
Site Status
Thoraxklinik Heidelberg gGmbH
Heidelberg, , Germany
Site Status
Klinikum der Universität München
München, , Germany
Site Status
Pius-Hospital
Oldenburg, , Germany
Site Status
The Chinese University of Hong Kong
Shatin, , Hong Kong
Site Status
Ospedale Santa Maria Delle Croci
Ravenna, Emilia-Romagna, Italy
Site Status
Istituto Nazionale Tumori Regina Elena
Rome, Lazio, Italy
Site Status
IEO
Milan, Lombardy, Italy
Site Status
Asst Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, Italy
Site Status
Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, , Netherlands
Site Status
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Site Status
National Cancer Centre
Singapore, , Singapore
Site Status
Seoul National University Hospital
Seoul, , South Korea
Site Status
Asan Medical Center
Seoul, , South Korea
Site Status
Samsung Medical Center
Seoul, , South Korea
Site Status
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Site Status
Institut Catala d Oncologia Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Site Status
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, , Spain
Site Status
Hospital Clinic de Barcelona
Barcelona, , Spain
Site Status
Hospital Ramon y Cajal
Madrid, , Spain
Site Status
Hospital Universitario 12 de Octubre
Madrid, , Spain
Site Status
National Taiwan University Hospital
Taipei, , Taiwan
Site Status
Taipei Veterans General Hospital
Taipei, , Taiwan
Site Status
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London, , United Kingdom
Site Status
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
Site Status
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Site Status
Countries
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United States
Belgium
China
France
Germany
Hong Kong
Italy
Netherlands
Singapore
South Korea
Spain
Taiwan
United Kingdom
References
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Subbiah V, Hu MI, Mansfield AS, Taylor MH, Schuler M, Zhu VW, Hadoux J, Curigliano G, Wirth L, Gainor JF, Alonso G, Adkins D, Godbert Y, Ahn MJ, Cassier PA, Cho BC, Lin CC, Zalutskaya A, Barata T, Trask P, Scalori A, Bordogna W, Heinzmann S, Brose MS. Pralsetinib in Patients with Advanced/Metastatic Rearranged During Transfection (RET)-Altered Thyroid Cancer: Updated Efficacy and Safety Data from the ARROW Study. Thyroid. 2024 Jan;34(1):26-40. doi: 10.1089/thy.2023.0363.
Reference Type
DERIVED
Subbiah V, Burris HA 3rd, Kurzrock R. Revolutionizing cancer drug development: Harnessing the potential of basket trials. Cancer. 2024 Jan;130(2):186-200. doi: 10.1002/cncr.35085. Epub 2023 Nov 7.
Reference Type
DERIVED
Griesinger F, Curigliano G, Subbiah V, Baik CS, Tan DS, Lee DH, Misch D, Garralda E, Kim DW, van der Wekken AJ, Gainor JF, Paz-Ares L, Liu SV, Kalemkerian GP, Bowles DW, Mansfield AS, Lin JJ, Smoljanovic V, Rahman A, Zalutskaya A, Louie-Gao M, Boral AL, Mazieres J. Pralsetinib in patients with RET fusion-positive non-small-cell lung cancer: A plain language summary of the ARROW study. Future Oncol. 2024 Feb;20(6):297-306. doi: 10.2217/fon-2023-0155. Epub 2023 Nov 2.
Reference Type
DERIVED
Zhou Q, Zhao J, Chang J, Wang H, Fan Y, Wang K, Wu G, Nian W, Sun Y, Sun M, Wang X, Shi H, Zheng X, Yao S, Qin M, Shen Z, Yang J, Wu YL. Efficacy and safety of pralsetinib in patients with advanced RET fusion-positive non-small cell lung cancer. Cancer. 2023 Oct 15;129(20):3239-3251. doi: 10.1002/cncr.34897. Epub 2023 Jun 6.
Reference Type
DERIVED
Subbiah V, Cassier PA, Siena S, Garralda E, Paz-Ares L, Garrido P, Nadal E, Vuky J, Lopes G, Kalemkerian GP, Bowles DW, Seetharam M, Chang J, Zhang H, Green J, Zalutskaya A, Schuler M, Fan Y, Curigliano G. Pan-cancer efficacy of pralsetinib in patients with RET fusion-positive solid tumors from the phase 1/2 ARROW trial. Nat Med. 2022 Aug;28(8):1640-1645. doi: 10.1038/s41591-022-01931-y. Epub 2022 Aug 12.
Reference Type
DERIVED
Popat S, Liu SV, Scheuer N, Hsu GG, Lockhart A, Ramagopalan SV, Griesinger F, Subbiah V. Addressing challenges with real-world synthetic control arms to demonstrate the comparative effectiveness of Pralsetinib in non-small cell lung cancer. Nat Commun. 2022 Jun 17;13(1):3500. doi: 10.1038/s41467-022-30908-1.
Reference Type
DERIVED
Subbiah V, Hu MI, Wirth LJ, Schuler M, Mansfield AS, Curigliano G, Brose MS, Zhu VW, Leboulleux S, Bowles DW, Baik CS, Adkins D, Keam B, Matos I, Garralda E, Gainor JF, Lopes G, Lin CC, Godbert Y, Sarker D, Miller SG, Clifford C, Zhang H, Turner CD, Taylor MH. Pralsetinib for patients with advanced or metastatic RET-altered thyroid cancer (ARROW): a multi-cohort, open-label, registrational, phase 1/2 study. Lancet Diabetes Endocrinol. 2021 Aug;9(8):491-501. doi: 10.1016/S2213-8587(21)00120-0. Epub 2021 Jun 9.
Reference Type
DERIVED
Gainor JF, Curigliano G, Kim DW, Lee DH, Besse B, Baik CS, Doebele RC, Cassier PA, Lopes G, Tan DSW, Garralda E, Paz-Ares LG, Cho BC, Gadgeel SM, Thomas M, Liu SV, Taylor MH, Mansfield AS, Zhu VW, Clifford C, Zhang H, Palmer M, Green J, Turner CD, Subbiah V. Pralsetinib for RET fusion-positive non-small-cell lung cancer (ARROW): a multi-cohort, open-label, phase 1/2 study. Lancet Oncol. 2021 Jul;22(7):959-969. doi: 10.1016/S1470-2045(21)00247-3. Epub 2021 Jun 9.
Reference Type
DERIVED
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-004390-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BLU-667-1101
Identifier Type: REGISTRY
Identifier Source: secondary_id
BO42863
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
PHASE3
Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (MK-3475-A86)
NCT04956692
ACTIVE_NOT_RECRUITING
PHASE3
Pemetrexed Disodium or Erlotinib Hydrochloride as Second-Line Therapy in Treating Patients With Advanced Non-small Cell Lung Cancer
NCT00738881
TERMINATED
PHASE3
Trametinib and Pembrolizumab in Treating Patients With Recurrent Non-small Cell Lung Cancer That Is Metastatic, Unresectable, or Locally Advanced
NCT03225664
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)
NCT04623775
ACTIVE_NOT_RECRUITING
PHASE2
A Study of RO5083945 in Combination With Chemotherapy Versus Chemotherapy Alone in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
NCT01185847
COMPLETED
PHASE2
Sintilimab After Stereotactic Ablation Brachytherapy for Refractory Oligometastatic Non-Small Cell Lung Cancer
NCT04486287
UNKNOWN
PHASE2
Anti-angiogenesis Agent AG-013736 in Patients With Advanced Non-Small Cell Lung Cancer
NCT00094094
COMPLETED
PHASE2
A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Treatment of Physician's Choice in Subjects With Advanced Non-Small Cell Lung Cancer
NCT01454934
COMPLETED
PHASE3
Phase I Study of Gene Induction Mediated by Sequential Decitabine/Depsipeptide Infusion With or Without Concurrent Celecoxib in Subjects With Pulmonary and Pleural Malignancies
NCT00037817
COMPLETED
PHASE1
Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC
NCT06162221
RECRUITING
PHASE1/PHASE2
A Trial of Pembrolizumab in Combination With Chemotherapy and Radiotherapy in Stage III NSCLC (KEYNOTE-799, MK-3475-799)
NCT03631784
COMPLETED
PHASE2
A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor (TKI) Therapy
NCT02864251
COMPLETED
PHASE3
Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-Small Cell Lung Cancer
NCT04475939
ACTIVE_NOT_RECRUITING
PHASE3
A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06)
NCT03322566
COMPLETED
PHASE2
Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients With Stage III/IV and Relapsed NSCLC
NCT00001450
COMPLETED
PHASE2
A Study to Compare the Combination of BMS-986504 With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion
NCT07063745
RECRUITING
PHASE2/PHASE3
Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
NCT00061854
COMPLETED
PHASE2