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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04956692
Other study ID # 3475-A86
Secondary ID MK-3475-A86jRCT2
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date August 5, 2021
Est. completion date October 14, 2026

Study information

Verified date May 2024
Source Merck Sharp & Dohme LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate pembrolizumab (MK-3475) subcutaneous (SC) administration as the first-line therapy in the treatment of metastatic squamous and nonsquamous NSCLC by assessing the pharmacokinetics (PK), safety, and efficacy of pembrolizumab SC injection in combination with standard-of-care chemotherapy. The primary hypothesis of the study is Pembrolizumab SC is noninferior to pembrolizumab intravenous (IV) for Cycle 1 Area Under Curve (AUC) and Cycle 6 minimal concentration (Ctrough) at steady state. Participants who discontinue study treatment after receiving the first course of 35 administrations of pembrolizumab (approximately up to 2 years) for reasons other than disease progression or intolerability, may be eligible for a second course of pembrolizumab for up to approximately 1 additional year if they have experienced radiographic disease progression per RECIST 1.1 as assessed by BICR after stopping first course treatment.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 531
Est. completion date October 14, 2026
Est. primary completion date April 4, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Has pathologically (histologically or cytologically) confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC) - Has Stage IV (T any, N any, M1a, M1b, or M1c - American Joint Committee on Cancer 8th Edition) squamous or nonsquamous NSCLC - Has confirmation that epidermal growth factor receptor (EGFR), Anaplastic lymphoma kinase (ALK), or ROS Proto-Oncogene 1, Receptor Tyrosine Kinase (ROS1)-directed therapy is not indicated in nonsquamous NSCLC as well as mixed nonsquamous/squamous NSCLC. Participants with purely squamous NSCLC do not require testing - Has not received prior systemic treatment for their metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease - Has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 or 1 - Male participants are eligible to participate if they agree to use contraception as per protocol unless confirmed to be azoospermic - A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP) or is a WOCBP who agrees of using a contraceptive method per protocol - Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology - Submit an archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated for PD-L1 status determination prior to randomization - Has adequate organ function Exclusion Criteria: - Has a known additional malignancy that is progressing or has required active treatment within the past 3 years - Has known central nervous system (ie, brain and/or spinal cord) metastases and/or carcinomatous meningitis. Participants with treated brain metastases may participate only if they satisfy all of the following: a) Have no evidence of new or enlarging brain metastases confirmed by post-treatment repeat brain imaging performed at least 4 weeks after pretreatment brain imaging, and b) Are neurologically stable without the need for steroids for at least 14 days before first dose of trial treatment as per local site assessment - Has severe hypersensitivity to study intervention and/or any of its excipients - Has an active autoimmune disease that has required systemic treatment in past 2 years - Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease - Has an active infection requiring systemic therapy - Has a known history of human immunodeficiency virus (HIV) infection and/or Hepatitis B infection or known active Hepatitis C infection - Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study - Has symptomatic ascites or pleural effusion. A participant who is clinically stable after treatment for these conditions is eligible - Before the first dose of study intervention: a) Has received prior systemic cytotoxic chemotherapy for metastatic NSCLC b) Has received antineoplastic biological therapy for metastatic NSCLC c) Has had major surgery (<3 weeks prior to first dose) d) Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor - Received radiation therapy to the lung that is >30 Gray within 6 months of the first dose of study intervention - Is expected to require any other form of antineoplastic therapy while on study - For participants with nonsquamous histology: Is unable to interrupt aspirin or other Non-steroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose =1.3 g/day, for a 5-day period - For participants with nonsquamous histology: Is unable or unwilling to take folic acid or vitamin B12 supplementation - Has received prior radiotherapy within 2 weeks of start of study intervention or have had a history of radiation pneumonitis. Participants must have recovered from all radiation-related toxicities and not require corticosteroids. A 1-week washout is permitted for palliative radiation (=2 weeks of radiotherapy) to non-CNS disease - Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention - Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention - Has had an allogenic tissue/solid organ transplant

Study Design


Intervention

Biological:
Pembrolizumab SC
SC injection
Pembrolizumab IV
IV injection
Drug:
Paclitaxel
IV injection
Nab-Paclitaxel
IV infusion
Carboplatin
IV infusion
Cisplatin
IV infusion
Pemetrexed
IV infusion

Locations

Country Name City State
Brazil HOSPITAL EVANGÉLICO DE CACHOEIRO DE ITAPEMIRIM ( Site 0307) Cachoeiro de Itapemirim Espirito Santo
Brazil Instituto Joinvilense de Hematologia e Oncologia ( Site 0308) Joinville Santa Catarina
Brazil Hospital Sao Vicente de Paulo ( Site 0311) Passo Fundo Rio Grande Do Sul
Brazil Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0305) Sao Jose do Rio Preto Sao Paulo
Brazil Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0304) São Paulo Sao Paulo
France CHU Limoges CHU Dupuytren ( Site 1011) Limoges Haute-Vienne
France Institut Regional du Cancer de Montpellier - ICM ( Site 1003) Montpellier Herault
France Hopital Cochin ( Site 1002) Paris
France Centre Hospitalier de Pau ( Site 1016) Pau Pyrenees-Atlantiques
France CHU de Rouen ( Site 1013) Rouen Seine-Maritime
France Hopital Guillaume & Rene Laennec ( Site 1007) Saint-Herblain Loire-Atlantique
France Centre Hospitalier Sud Réunion ( Site 1020) Saint-Pierre La Reunion
France Nouvel Hôpital Civil (NHC) ( Site 1018) Strasbourg Bas-Rhin
France Hôpital Foch ( Site 1019) Suresnes Hauts-de-Seine
Guatemala Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0602) Guatemala
Guatemala Clinica Privada Dr. Rixci Ramirez ( Site 0601) Guatemala
Guatemala Grupo Angeles SA ( Site 0604) Guatemala
Guatemala INTERVASC ( Site 0605) Guatemala
Guatemala Centro Regional de Sub Especialidades Médicas SA ( Site 0600) Quetzaltenango
Hungary Orszagos Koranyi Pulmonologiai Intezet ( Site 1104) Budapest
Hungary Semmelweis University-Pulmonológiai Klinika ( Site 1114) Budapest
Hungary Veszprem Megyei Tudogyogyintezet ( Site 1108) Farkasgyepu Veszprem
Hungary Petz Aladar Megyei Oktato Korhaz ( Site 1110) Gyor Gyor-Moson-Sopron
Hungary Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1106) Kecskemét Bacs-Kiskun
Hungary Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1103) Szolnok Jasz-Nagykun-Szolnok
Hungary Tudogyogyintezet Torokbalint ( Site 1105) Torokbalint Pest
Hungary Zala Megyei Szent Rafael Korhaz ( Site 1111) Zalagerszeg Zalaegerszeg
Japan Chiba University Hospital ( Site 3008) Chiba
Japan National Hospital Organization Kyushu Cancer Center ( Site 3002) Fukuoka
Japan National Hospital Organization Kyushu Medical Center ( Site 3001) Fukuoka
Japan Kansai Medical University Hospital ( Site 3016) Hirakata Osaka
Japan Kanazawa University Hospital ( Site 3004) Kanazawa Ishikawa
Japan Kurashiki Central Hospital ( Site 3013) Kurashiki Okayama
Japan Kurume University Hospital ( Site 3006) Kurume Fukuoka
Japan Miyagi Cancer Center ( Site 3000) Natori Miyagi
Japan Okayama University Hospital ( Site 3012) Okayama
Japan Osaka International Cancer Institute ( Site 3018) Osaka
Japan National Hospital Organization Kinki-chuo Chest Medical Center ( Site 3009) Sakai Osaka
Japan National Hospital Organization Hokkaido Cancer Center ( Site 3014) Sapporo Hokkaido
Japan Sendai Kousei Hospital ( Site 3015) Sendai Miyagi
Japan Osaka Medical and Pharmaceutical University Hospital ( Site 3017) Takatsuki Osaka
Japan Tokushima University Hospital ( Site 3019) Tokushima
Japan Juntendo University Hospital ( Site 3011) Tokyo
Japan Showa University Hospital ( Site 3010) Tokyo
Japan Ehime University Hospital ( Site 3005) Toon Ehime
Japan Fujita Health University Hospital ( Site 3007) Toyoake Aichi
Japan Kanagawa Cardiovascular and Respiratory Center ( Site 3003) Yokohama Kanagawa
Korea, Republic of Chungnam National University Hospital ( Site 2002) Daejeon Chungnam
Korea, Republic of Chonnam National University Hwasun Hospital-Pulmonology ( Site 2000) Hwasun Jeonranamdo
Korea, Republic of Korea University Guro Hospital ( Site 2003) Seoul
Peru Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 0704) Arequipa Ariqipa
Peru Clinica Internacional Sede San Borja ( Site 0705) Lima
Peru Hospital Nacional Cayetano Heredia ( Site 0700) Lima
Peru Instituto Nacional de Enfermedades Neoplasicas ( Site 0703) Lima
Peru Oncosalud ( Site 0706) Lima Muni Metro De Lima
Peru Clínica Peruano-Americana de Trujillo ( Site 0701) Trujillo La Libertad
Poland Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 1201) Bydgoszcz Kujawsko-pomorskie
Poland Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1205) Bystra Slaskie
Poland Przychodnia Lekarska KOMED ( Site 1202) Konin Wielkopolskie
Poland Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1200) Koszalin Zachodniopomorskie
Poland Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1206) Siedlce Mazowieckie
Poland Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Warszawa Mazowieckie
Romania S.C.Focus Lab Plus S.R.L ( Site 1301) Bucuresti
Romania Spitalul Universitar de Urgenta Bucuresti ( Site 1305) Bucuresti
Romania Cardiomed SRL Cluj-Napoca ( Site 1313) Cluj-Napoca Cluj
Romania Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1303) Cluj-Napoca Cluj
Romania SC Radiotherapy Center Cluj SRL ( Site 1307) Comuna Floresti Cluj
Romania Centrul de Oncologie Oncolab-Medical Oncology ( Site 1312) Craiova Dolj
Romania S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1304) Craiova Dolj
Romania Spitalul Municipal Ploiesti ( Site 1308) Ploiesti Prahova
Romania Policlinica Oncomed SRL ( Site 1302) Timisoara Timis
Russian Federation Republican Clinical Oncology Dispensary-Chemotherapy #1 ( Site 1425) Kazan Tatarstan, Respublika
Russian Federation National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1407) Saint-Petersburg Sankt-Peterburg
Russian Federation Saint-Petersburg Scientific-Practical Center of Specialized Kinds of Medical Care (o) ( Site 1424) Saint-Petersburg Sankt-Peterburg
Russian Federation SPBU Clinic of Advanced medical technologies n.a. N. I. Pirogov ( Site 1406) Saint-Petersburg Sankt-Peterburg
Russian Federation SPb SBHI City Clinical Oncological Dispensary ( Site 1409) Sankt-Peterburg
South Africa The Oncology Centre ( Site 1507) Durban Limpopo
South Africa Wits Clinical Research ( Site 1510) Johannesburg Gauteng
South Africa Cape Town Oncology Trials Pty Ltd ( Site 1500) Kraaifontein Western Cape
South Africa Marry Potter Oncology Centre ( Site 1502) Pretoria Gauteng
South Africa Steve Biko Academic Hospital ( Site 1506) Pretoria Gauteng
South Africa Sandton Oncology Medical Group PTY LTD ( Site 1505) Sandton Gauteng
South Africa Chris Hani Baragwanath Academic Hospital-Wits Clinical Research Bara ( Site 1513) Soweto Gauteng
Spain H.U. Vall de Hebron ( Site 1600) Barcelona
Spain Hospital Juan Ramon Jimenez ( Site 1602) Huelva
Spain Hospital Insular de Gran Canaria-Oncology ( Site 1604) Las Palmas de Gran Canaria Las Palmas
Spain Hospital Universitario Lucus Augusti ( Site 1603) Lugo
Spain Hospital Universitario La Paz ( Site 1601) Madrid
Taiwan Changhua Christian Hospital ( Site 2104) Changhua
Taiwan National Taiwan University Hospital Hsin-Chu Branch ( Site 2103) Hsinchu
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2107) Kaohsiung
Taiwan National Cheng Kung University Hospital ( Site 2105) Tainan
Taiwan National Taiwan University Hospital ( Site 2101) Taipei
Taiwan Taipei Veterans General Hospital ( Site 2106) Taipei
Taiwan Chang Gung Medical Foundation-Linkou Branch ( Site 2102) Taoyuan
Turkey Ankara Sehir Hastanesi ( Site 1702) Ankara
Turkey Gulhane Egitim ve Arastirma Hastanesi ( Site 1704) Ankara
Turkey TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1701) Istanbul
Turkey Ege Universitesi Tip Fakultesi Hastanesi ( Site 1703) Izmir
Turkey Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 1707) Malatya
Ukraine Communal non profit enterprise Regional Clinical Oncology Center ( Site 1806) Kharkiv Kharkivska Oblast
Ukraine Medical Center Asklepion LLC ( Site 1804) Khodosivka Kyivska Oblast
Ukraine Kremenchuk Regional Oncology Center ( Site 1811) Kremenchuk Poltavska Oblast
Ukraine Ukrainian Center of Tomotherapy ( Site 1807) Kropyvnytskyi Kirovohradska Oblast
Ukraine Medical Center Mriya Med-Service ( Site 1805) Kryvyi Rih Dnipropetrovska Oblast
Ukraine Kyiv City Clinical Oncology Centre ( Site 1809) Kyiv
Ukraine Medical Center Dobrobut Clinic ( Site 1808) Kyiv
Ukraine Municipal non-profit enterprise'Odesa Regional Clinical Hosp-Thoracic surgery department. ( Site 181 Odesa Odeska Oblast
United States St. Vincent Frontier Cancer Center ( Site 0058) Billings Montana
United States Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 0100) Blacksburg Virginia
United States Montefiore Medical Center [Bronx, NY] ( Site 0040) Bronx New York
United States Holy Cross Hospital ( Site 0017) Fort Lauderdale Florida
United States Fort Wayne Medical Oncology and Hematology ( Site 0101) Fort Wayne Indiana
United States St Joseph Heritage Healthcare-Oncology ( Site 0102) Fullerton California
United States Memorial Regional Hospital-Memorial Cancer Institute ( Site 0104) Hollywood Florida
United States Millennium Physicians - Oncology ( Site 0097) Houston Texas
United States Oncology Consultants, PA ( Site 0052) Houston Texas
United States St. Bernards Medical Center ( Site 0103) Jonesboro Arkansas
United States St Luke's Hospital - Kansas City ( Site 0033) Kansas City Missouri
United States The University of Tennessee Medical Center ( Site 0050) Knoxville Tennessee
United States Baptist Health Lexington ( Site 0099) Lexington Kentucky
United States Cancer Blood and Specialty Clinic ( Site 0105) Los Alamitos California
United States West Virginia University ( Site 0056) Morgantown West Virginia
United States Tennessee Oncology ( Site 0051) Nashville Tennessee
United States Advent Health ( Site 0013) Orlando Florida
United States PIH Health Hematology Medical Oncology ( Site 0106) Whittier California

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Brazil,  France,  Guatemala,  Hungary,  Japan,  Korea, Republic of,  Peru,  Poland,  Romania,  Russian Federation,  South Africa,  Spain,  Taiwan,  Turkey,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cycle 1 Area Under The Curve From 0-3 Weeks (AUC 0-3wks) of Pembrolizumab Cycle 1 AUC0-3wks is defined as the area under the concentration-time curve for pembrolizumab in plasma over a 3-week dosing interval in Cycle 1. Each cycle is 21 days. Cycle 1: predose and postdose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 2: predose day 1. Each cycle is 21 days.
Primary Cycle 6 Model-Based Minimal Concentration (Ctrough) of Pembrolizumab Cycle 6 model-based Ctrough is defined as the lowest concentration of pembrolizumab in plasma at the end of the dosing interval in Cycle 6, as predicted by the pharmacokinetic (PK) model based on historical intravenous pembrolizumab PK data. Each cycle is 21 days. Cycle 6: predose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 7: predose day 1. Each cycle is 21 days.
Secondary Objective Response (OR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) The OR rate is defined as the percentage of participants who achieve a confirmed complete response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by BICR. Up to approximately 5 years
Secondary Cycle 1 Observed Ctrough of Pembrolizumab Cycle 1 observed Ctrough is defined as the lowest observed concentration of pembrolizumab in plasma at the end of the dosing interval in Cycle 1. Each cycle is 21 days. Predose Cycle 2 day 1. Each cycle is 21 days.
Secondary Cycle 1 Maximum Concentration (Cmax) of Pembrolizumab Cycle 1 Cmax is defined as the observed peak concentration of pembrolizumab in plasma over the dosing interval in Cycle 1. Each cycle is 21 days. Cycle 1: predose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 2: predose day 1. Each cycle is 21 days.
Secondary Cycle 6 AUC 0-3wks of Pembrolizumab Cycle 6 AUC0-3wks is defined as the area under the concentration-time curve for pembrolizumab in plasma over a 3-week dosing interval in Cycle 6. Each cycle is 21 days. Cycle 6: predose and postdose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 7: predose day 1. Each cycle is 21 days.
Secondary Cycle 6 Cmax of Pembrolizumab Cmax in Cycle 6 is defined as the observed peak concentration of pembrolizumab in plasma over the dosing interval in Cycle 6. Each cycle is 21 days. Cycle 6: predose and postdose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 7: predose day 1. Each cycle is 21 days.
Secondary Cycle 6 Observed Ctrough of Pembrolizumab Cycle 6 observed Ctrough is defined as the lowest observed concentration of pembrolizumab in plasma at the end of the dosing interval in Cycle 6. Each cycle is 21 days. Predose Cycle 7 day 1. Each cycle is 21 days.
Secondary Number of Participants Who Experienced an Adverse Event (AE) An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE will be reported. Up to approximately 28 months
Secondary Number of Participants Who Discontinued Study Treatment Due to an AE An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. The number of participants who discontinue study treatment due to an AE will be presented. Up to approximately 25 months
Secondary Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD. Up to approximately 5 years
Secondary Overall Survival (OS) OS is defined as the time from randomization to death due to any cause. Up to approximately 5 years
Secondary Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR For participants who show confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression (PD) per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. Up to approximately 5 years
Secondary Anti-Drug Antibodies (ADAs) Incidence After Administration of Pembrolizumab ADA incidence will be assessed by analyzing the development of ADAs following administration of pembrolizumab SC and pembrolizumab IV. Up to approximately 26 months
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